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What is Diphtheria vaccine?

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In the U.S. today, diphtheria vaccine is administered only in a combination shot (DTaP, DT, Tdap, Td) that contains vaccines for tetanus (T), diphtheria (D) and possibly pertussis (whooping cough) (P). It can also be found in combination with vaccines for polio, Haemophilus influenzae B (HIB), and hepatitis B (see below for descriptions).

The CDC’s Advisory Committee on Immunization Practices (ACIP) currently recommends administration of a diphtheria containing vaccine (DTaP) at two, four, and six months old; between 15 and 18 months old; and between four and six years old. Another booster dose is recommended at 11-12 years of age (Tdap). After a booster dose of Tdap vaccine, booster doses with a diphtheria toxoid (Td or Tdap) are recommended every ten years throughout a person’s life.

While ACIP also recommends that pregnant women between 27- and 36-weeks gestation receive a dose of Tdap vaccine during each pregnancy, regardless of a previous history of Tdap vaccine, this recommendation contradicts the information provided by the vaccine manufacturers. Boostrix vaccine is approved to be administered only as a single dose and the Adacel package insert states that a second dose of Adacel vaccine may be administered if there has been at least an eight year interval between the first Tdap dose. The product insert of both Boostrix and Adacel, the two available FDA licensed Tdap vaccines, also state that there are “no adequate and well-controlled studies” on the use of Tdap vaccine in pregnant women.

Diphtheria Toxoid Vaccines Licensed for Use in the U.S.

The U.S. Food and Drug Administration has approved twelve different combination vaccine that include diphtheria toxoid vaccine. There are different rules for use of these vaccines by different age groups.

Following is a list of currently available vaccine combination shots that contain diphtheria toxoid vaccine with links to the manufacturer product inserts (click on the name of the product):

Infanrix, a 3 in 1 combination shot containing diphtheria, tetanus toxoids, and acellular pertussis vaccine for children under 7 years of age. It is manufactured by GlaxoSmithKline.
DAPTACEL, a 3 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis vaccine for children under 7 years of age. It is manufactured by Sanofi Pasteur Ltd.
Pediarix, a 5 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, hepatitis B recombinant and inactivated poliovirus vaccines for children under 7 years of age. It is manufactured by GlaxoSmithKline.
Kinrix, a 4 in 1 combination vaccine containing diphtheria and tetanus toxoids, acellular pertussis and inactivated poliovirus vaccines for children 4 to 6 years old. It is manufactured by GlaxoSmithKline.
Quadracel, a 4 in 1 combination vaccine containing diphtheria and tetanus toxoid, acellular pertussis and inactivated poliovirus vaccine for children 4 to 6 years old. It is manufactured by Sanofi Pasteur
Pentacel, a 5 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine for children under four years old. It is manufactured by Sanofi Pasteur Ltd.
VAXELIS, a 6 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus b conjugate, and hepatitis B recombinant vaccine for children under 5 years of age. It is manufactured by MCM Vaccine Company. (Not currently available for use)
Diphtheria and Tetanus Toxoid Adsorbed, a 2 in 1 combination shot containing diphtheria and tetanus toxoid for children under seven years old. It is manufactured by Sanofi Pasteur Ltd
Adacel, a 3 in 1 combination booster shot containing tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine for those 10 years or older. It is manufactured by Sanofi Pasteur Ltd.
Boostrix, a 3 in 1 combination booster shot containing tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine for those 10 years or older. It is manufactured by GlaxoSmithKline.
TDVAX, a 2 in 1 combination shot containing tetanus and diphtheria toxoid for those 7 years of age or older. It is manufactured by MassBiologics
TENIVAC, a 2 in 1 combination shot containing tetanus and diphtheria toxoid for those 7 years of age or older. It is manufactured by Sanofi Pasteur

Combination Vaccines

There are some doctors who limit the number of vaccines given simultaneously on the same day and will work as partners with parents to choose certain vaccine products and develop individualized schedules for vaccination. If you want your child to receive diphtheria vaccine but would prefer a 3 in 1 combination shot (diphtheria, tetanus, and pertussis) rather than a 4 in 1 or 5 in 1 combination shot, talk with your doctor.

If your doctor or the nurse administering vaccines refuses to have a discussion with you about vaccine products or schedules, you may want to consider consulting one or more other trusted health care professionals before making a vaccine decision.

Not all diphtheria-containing vaccines have been studied in clinical trials to prove the safety and effectiveness of giving the shot simultaneously with other licensed vaccines. Check the product inserts for more information about administering vaccines at the same time with other vaccines.

About Infanrix Vaccine in Brief

Ages: Infanrix is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis vaccine) given to children under age seven (see GlaxoSmithKline product insert for recommended schedule and other indications).
Vaccine ingredients: Aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 80), formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde, fenton medium containing a bovine extract, modified Latham medium derived from bovine casein.
Estimated Efficacy: Efficacy of diphtheria toxoid in Infanrix was based on immunogenicity (blood immune response) and was tested in only 45 infants one month following the completion of three doses of Infanrix vaccine. At this time, 100 percent of infants had a blood immune response to Infanrix
Use with Other Vaccines: In clinical trials, Infanrix was given with HIB, pneumococcal, hepatitis B, inactivated polio or MMR vaccines. There is no information in the package insert about the safety or effectiveness of giving Infanrix simultaneously with inactivated or live influenza, rotavirus, varicella or hepatitis A vaccines.
Commonly Reported Adverse Events: Pain, redness, and swelling at the site of the injection; drowsiness; irritability/fussiness; loss of appetite.
Other Serious Reported Adverse Events: Hypotonic-hyporesponsive (collapse) episode; persistent cry for three or more hours; high fever, and convulsions (seizures). After licensure (post-marketing), reported adverse events included bronchitis, cellulitis, respiratory tract infection, lymphadenopathy, thrombocytopenia, anaphylactic reaction, encephalopathy, headache, hypotonia, ear pain, apnea, cough, angioedema, pruritus, rash, fatigue and Sudden Infant Death Syndrome (SIDS).
Contraindications and precautions (Some reasons Infanrix should not be given to a child – See GlaxoSmithKline product insert for complete list):
- Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
- Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
- Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
- Convulsions with or without fever, occurring within three days of a previous pertussis vaccination;
- Serious allergic reaction to a previous pertussis vaccination;
- Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within seven days of a previous pertussis vaccination not attributable to another identifiable cause;
- Children with a progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy;
- Apnea following intramuscular vaccination has been observed in some infants born prematurely. Infanrix vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Infanrix vaccine;
- The tip caps of prefilled Infanrix syringes contain latex and may cause an allergic reaction in persons sensitive to latex.

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Infanrix. It is also not known whether Infanrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Infanrix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About DAPTACEL Vaccine in Brief

Ages: DAPTACEL is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis vaccines) given to children under age seven (see Sanofi Pasteur product insert for recommended schedule and other indications).
Vaccine ingredients: Aluminum phosphate, formaldehyde, ammonium sulfate, modified Mueller-Miller casamino acid medium without beef heart infusion, glutaraldehyde, 2-phenoxyethanol, Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin, Mueller’s growth medium.
Estimated Efficacy: In a U.S study of children who received four doses of DAPTACEL vaccine at two, four, six and 15-17 months, after administration of the third dose of vaccine (at six months of age), 100 percent of vaccine recipients were found to have blood antibody levels indicative of protection. Following administration of the fourth dose of DAPTACEL, 96.5 percent of children sampled were found to have levels of blood antibodies considered to be protective against diphtheria disease.
Use with Other Vaccines: In clinical trials, DAPTACEL was given with HIB, inactivated polio (IPV), hepatitis B, pneumococcal, and MMR or varicella vaccines. There is no information in the package insert about the safety or effectiveness of giving DAPTACEL simultaneously with inactivated or live influenza, rotavirus, or hepatitis A vaccines. DAPTACEL has been noted to reduce meningococcal antibody responses to Menactra when administered one month after Menactra. In cases where DAPTACEL and Menactra are to be administered, the vaccines are recommended to be given at the same time or else one month apart, with Menactra administered first.
Commonly Reported Adverse Events: Injection site soreness, tenderness, redness, and increase in arm circumference; fussiness/irritability; inconsolable crying; decreased activity/lethargy.
Other Serious Reported Adverse Events: Convulsions (seizures), including infantile spasms; bronchiolitis; pneumonia; meningitis; sepsis; irritability; unresponsiveness. After licensure (post-marketing), reported adverse events have also included cyanosis, nausea, diarrhea, cellulitis, and allergic reaction.
Contraindications and precautions (Some reasons DAPTACEL should not be given to a child – See Sanofi Pasteur product insert for complete list):
- Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
- Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
- Persistent crying lasting three hours or more within 48 hours of a previous pertussis vaccination;
- Convulsions with or without fever, occurring within three days of a previous pertussis vaccination;
- Serious allergic reaction to a previous pertussis vaccination;
- Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within seven days of a previous pertussis vaccination not attributable to another identifiable cause;
- Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy).
- Apnea following intramuscular vaccination has been observed in some infants born prematurely. DAPTACEL vaccine package insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering DAPTACEL vaccine.

Animal reproduction studies have not been conducted with DAPTACEL. It is not known whether DAPTACEL can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. DAPTACEL has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Pediarix Vaccine in Brief

Ages: Pediarix is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio and recombinant hepatitis B vaccines) given to children under age seven (see GlaxoSmithKline product insert for recommended schedule and other indications).
Vaccine Ingredients: Aluminum hydroxide, aluminum phosphate, aluminum salts, sodium chloride, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B, yeast protein, VERO cells, a continuous line of monkey kidney cells, calf serum and lactalbumin hydrolysate, fenton medium containing a bovine extract, modified Latham medium derived from bovine casein, formaldehyde, glutaraldehyde, modified Stainer-Scholte liquid medium.
Estimated Efficacy: Antibody responses to diphtheria were tested one month following three doses of Pediarix administered in concomitantly with Hib vaccine and PCV7 (Prevnar 7) vaccine at two, four, and six months. At this time, 99.4 percent of vaccine recipients were found to have blood antibody levels considered to be protective against diphtheria.
Use with Other Vaccines: In clinical trials, Pediarix was given with HIB conjugate vaccine (no longer licensed in the U.S.) or pneumococcal vaccines (PCV7). There is no information in the package insert about the safety or effectiveness of giving Pediarix simultaneously with inactivated or live influenza, rotavirus, or hepatitis A vaccines.
Commonly Reported Adverse Events: Local injection site reactions (pain, redness, or swelling); fussiness, high fever (Pediarix is associated with higher rates of fever relative to separately administered vaccines. The prevalence of fever was highest on the day of vaccination and the day following vaccination).
Other Serious Reported Adverse Events: High fever that required medical attention (In a safety study that evaluated medically attended fever after Pediarix or separately administered vaccines when co-administered with 7-valent pneumococcal and Hib conjugate vaccines, infants who received Pediarix had a higher rate of medical encounters for fever within the first four days following the first vaccination); febrile and afebrile convulsions (seizures); gastroenteritis, bronchiolitis; asthma, diabetes mellitus, and chronic neutropenia; anaphylactic reactions (hives, swelling, difficulty breathing, hypotension or shock), demyelinating diseases.
Contraindications and precautions (Some reasons why Pediarix should not be given to a child – See GlaxoSmithKline product insert for complete list):
- Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
- Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
- Persistent crying lasting three hours or more within 48 hours of a previous pertussis vaccination;
- Convulsions with or without fever, occurring within three days of a previous pertussis vaccination;
- Serious allergic reaction to a previous pertussis vaccination;
- Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within seven days of a previous pertussis vaccination not attributable to another identifiable cause;
- Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
- Sensitivity to any component of Pediarix, including yeast or neomycin and polymyxin B (antibiotics);
- Apnea following intramuscular vaccination has been observed in some infants born prematurely. Pediarix vaccine package insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
- The tip caps of prefilled Pediarix syringes contain latex and may cause an allergic reaction in persons sensitive to latex;
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Pediarix vaccine.

Animal reproduction studies have not been conducted with Pediarix. It is not known whether Pediarix can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Pediarix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Kinrix Vaccine in Brief:

Ages: Kinrix is a 4 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio vaccines) given to children four to six years old (see GlaxoSmithKline product insert for recommended schedule and other indications).
Vaccine Ingredients: Aluminum hydroxide, VERO cells - a continuous line of monkey kidney cells, calf serum, lactalbumin hydrolysate, fenton medium containing a bovine extract, modified Latham medium derived from bovine casein, formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde, sodium chloride, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B.
Estimated Efficacy: The efficacy of the diphtheria toxoid component of Kinrix is estimated to be equal to that of Infanrix.
Use with Other Vaccines: In clinical trials, Kinrix was administered simultaneously with the second dose of MMR or MMR and Varicella vaccine. There is no information in the product insert about the safety or effectiveness of giving Kinrix simultaneously with inactivated or live influenza, hepatitis B, or hepatitis A vaccines.
Commonly Reported Adverse Events: Injection site pain, including redness, swelling and increase in arm circumference; drowsiness; fever; loss of appetite.
Other Serious Reported Adverse Events: Gastroenteritis, dehydration, and cellulitis. After licensure (post-marketing) reported adverse event reports have also included apnea, collapse or shock-like state (hypotonic-hyporesponsive episode), convulsions (with or without fever), injection site vesicles; pruritus (intense itching); allergic reactions, including anaphylaxis; urticaria; angioedema; lympadenopathy, and thrombocytopenia.
Contraindications and precautions (Some reasons why Kinrix should not be given to a child – See GlaxoSmithKline product insert for complete list):
- Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
- Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
- Persistent crying lasting three hours or more within 48 hours of a previous pertussis vaccination;
- Convulsions with or without fever, occurring within three days of a previous pertussis vaccination;
- Serious allergic reaction to a previous pertussis vaccination;
- Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within seven days of a previous pertussis vaccination not attributable to another identifiable cause;
- Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
- Severe allergic reaction to any component of Kinrix, including neomycin and polymyxin B (antibiotics);
- The tip caps of prefilled Kinrix syringes contain latex and may cause an allergic reaction in persons sensitive to latex;
- If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Kinrix vaccine.

Animal reproduction studies have not been conducted with Kinrix. It is not known whether Kinrix can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Kinrix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Quadracel Vaccine in Brief:

Ages: Quadracel is a 4 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio vaccines) given to children four to six years old (see Sanofi Pasteur product insert for recommended schedule and other indications).
Vaccine Ingredients: Aluminum phosphate, Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin, MRC-5 cells, normal human diploid cells, CMRL 1969 medium supplemented with calf serum, modified Mueller’s growth medium, ammonium sulfate, modified Mueller-Miller casamino acid medium without beef heart infusion, formaldehyde, 2-phenoxyethanol, polysorbate 80, glutaraldehyde, neomycin, polymyxin B sulfate.
Estimated Efficacy: The efficacy of the diphtheria toxoid vaccine component of Quadracel is estimated to be equal to that of DAPTACEL.
Use with Other Vaccines: In clinical trials, Quadracel was administered simultaneously with the MMR and varicella. There is no information in the product insert about the safety or effectiveness of giving Quadracel simultaneously with inactivated or live influenza, hepatitis A, or hepatitis B vaccines.
Commonly Reported Adverse Events: Injection site pain, including redness, swelling and increase in arm circumference; malaise; muscle pain; headache.
Other Serious Reported Adverse Events: After licensure (post-marketing) reported adverse event reports have also included cyanosis; convulsions (with or without fever); injection site abscess; injection site cellulitis; pallor; screaming; allergic reactions, including anaphylaxis; urticarial, and dyspnea.
Contraindications and precautions (Some reasons why Quadracel should not be given to a child – See Sanofi Pasteur product insert for complete list):
- Serious allergic reaction following administration of a pertussis, tetanus, diphtheria, or polio containing vaccine or any ingredient of Quadracel vaccine;
- Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within seven days of a previous pertussis vaccination not attributable to another identifiable cause;
- Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
- Seizures within three days of a previous pertussis vaccination;
- Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Quadracel vaccine.

Animal reproduction studies have not been conducted with Quadracel. It is not known whether Quadracel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Quadracel has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Pentacel Vaccine in Brief:

Ages: Pentacel is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae b conjugate vaccines) for children under age five (see Sanofi Pasteur product insert for recommended schedule and other indications).
Vaccine Ingredients: Aluminum phosphate, polysorbate 80, sucrose, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxyethanol, MRC-5 cells (a line of normal human diploid cells), CMRL 1969 medium supplemented with calf serum, Medium 199 without calf serum, modified Mueller and Miller medium, neomycin, polymyxin B sulfate, modified Mueller’s growth medium, ammonium sulfate, modified Mueller-Miller casamino acid medium without beef heart infusion, Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin.

Estimated Efficacy: Antibody responses to tetanus were tested one month following three doses of Pentacel at two, four, and six months. At this time, 98.8 percent of vaccine recipients were found to have blood antibody levels considered to be protective against diphtheria. Following a booster dose of Pentacel at 15-16 months, 100 percent of vaccine recipients were noted to have blood antibody levels considered protective against diphtheria.

Use with Other Vaccines: In clinical trials, Pentacel was given with hepatitis B, pneumococcal, MMR or varicella vaccines. There is no information in the package insert about the safety or effectiveness of giving Pentacel simultaneously with inactivated or live influenza, rotavirus, or hepatitis A vaccines
Commonly Reported Adverse Events: Systemic reactions that occurred in clinical trials in more than 50 percent of participants following any dose included fussiness/irritability and inconsolable crying; fever; injection site reactions, including tenderness, abscess and increase in arm circumference. Cases of encephalopathy and death occurred in clinical trials but were not causally attributed to Pentacel vaccine by investigators.
Other Serious Reported Adverse Events: After licensure (post marketing), there have been reports of febrile and afebrile convulsions (seizures); bronchiolitis, gastroenteritis, dehydration, pneumonia, lethargy/somnolence; hypotonic/hyporesponsive episode (collapse); apnea, cyanosis, asthma.
Contraindications and precautions (Some reasons why Pentacel should not be given to a child – See Sanofi Pasteur product insert for complete list):
- Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
- Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
- Persistent crying lasting three hours or more within 48 hours of a previous pertussis vaccination;
- Convulsions with or without fever, occurring within three days of a previous pertussis vaccination;
- Serious allergic reaction to a previous pertussis vaccination;
- Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within seven days of a previous pertussis vaccination not attributable to another identifiable cause;
- Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
- Severe allergic reaction to any component of Pentacel, including neomycin and polymyxin B (antibiotics);
- Apnea following intramuscular vaccination has been observed in some infants born prematurely. Pentacel vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Pentacel vaccine.

NVIC NOTE: Some doctors only vaccinate children, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Pentacel. It is not known whether Pentacel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Pentacel has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About VAXELIS Vaccine in Brief:

Ages: VAXELIS is a 6 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, Haemophilus influenzae b (Meningococcal Protein Conjugate) and Hepatitis B (recombinant) vaccines for infants and children between six weeks through four years of age (prior to the fifth birthday) (see MCM company product insert for recommended schedule and other indications).
Vaccine Ingredients: Aluminum, polysorbate 80, glutaraldehyde, formaldehyde, bovine serum albumin, neomycin, streptomycin sulfate, polymyxin B sulfate, yeast protein, ammonium thiocyanate, Mueller’s growth medium, Mueller-Miller casamino acid medium without beef heart infusion, ammonium sulfate, aluminum phosphate, Stainer-Scholte medium, Vero cells, extract of yeast, soy peptone, dextrose, amino acids, mineral salts, amorphous aluminum hydroxyphosphate sulfate.

Estimated Efficacy: Diphtheria antibodies measured one month following administration of three doses of VAXELIS were found to be at 82.4 percent.
Use with Other Vaccines: In clinical trials, VAXELIS was given with pneumococcal (Prevnar 13) and rotavirus (RotaTeq) vaccines. There is no information in the package insert about the safety or effectiveness of giving VAXELIS simultaneously with inactivated or live influenza, hepatitis A, measles, mumps, rubella (MMR), varicella, or measles, mumps, rubella and varicella (MMR-V) vaccines.

Commonly Reported Adverse Events: Systemic reactions that occurred in clinical trials following any dose included injection site redness, swelling, and pain, fever, crying, decreased appetite, irritability, vomiting, and somnolence.
Other Serious Reported Adverse Events: In the two U.S. clinical trials, six deaths were reported but were determined not to be attributed to VAXELIS by trial investigators. These deaths included sepsis, asphyxia, hydrocephalus, unknown cause, and two cases of sudden infant death syndrome (SIDS). As VAXELIS is not currently available for use in the United States, post-marketing data on serious adverse events are limited to those events considered to have a causal link to the vaccines containing the antigens of VAXELIS. These include anaphylaxis, hypersensitivity, seizures, including febrile seizures, and excessive swelling of the injected limb.
Contraindications and precautions (Some reasons why VAXELIS should not be given to a child – See MCM Vaccine Company product insert for complete list):
- Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
- Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
- Persistent crying lasting three hours or more within 48 hours of a previous pertussis vaccination;
- Convulsions with or without fever, occurring within three days of a previous pertussis vaccination;
- Serious allergic reaction to a previous dose of VAXELIS, any ingredient found in VAXELIS, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, hepatitis B vaccine, inactivated poliovirus vaccine, or H. influenzae type b vaccine;
- Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within seven days of a previous pertussis vaccination not attributable to another identifiable cause;
- Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering VAXELIS vaccine;
- Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision to vaccinate an infant born prematurely should be careful based on both the possible benefits and potential risks of vaccination.

NVIC NOTE: Some doctors only vaccinate children, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with VAXELIS. It is not known whether VAXELIS can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. VAXELIS has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Diphtheria and Tetanus Toxoid Adsorbed Vaccine in Brief:

Ages: Diphtheria and Tetanus Toxoid Adsorbed is a 2 in 1 shot (diphtheria and tetanus) for children six weeks to six years of age (see Sanofi Pasteur product insert for recommended schedule and other indications). It is used in cases where pertussis vaccine should not be administered.
Vaccine Ingredients: aluminum phosphate, isotonic sodium chloride, uracil, inorganic salts, vitamins, dextrose, formaldehyde, casein, cystine, maltose.

Estimated Efficacy: Efficacy of diphtheria toxoid in Diphtheria and Tetanus Toxoid Adsorbed was based on immunogenicity (blood immune response) and tested in 137 infants only two months following the completion of three doses of the vaccine (given at two, four, and six months). 99 percent of infants were noted to have blood antibody levels considered protective against tetanus, two months following three doses of the vaccine.

Use With Other Vaccines No clinical trials examined the safety or effectiveness of administering the vaccine with any other U.S. licensed vaccine.
Commonly Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site, loss of appetite, crying, and fever. Adverse events were noted for only 24 hours following vaccination. In clinical trials, the Diphtheria and Tetanus Toxoid Adsorbed vaccine contained thimerosal (mercury).
Other Serious Reported Adverse Events: After licensure (post marketing) adverse event reports have included injection site pain, swelling and hypersensitivity; syncope; convulsion; somnolence; headache; rash; pallor; itching; lymphadenopathy;
Contraindications and precautions (Some reasons why Diphtheria and Tetanus Toxoid Adsorbed should not be given to a child – See Sanofi Pasteur product insert for complete list):
- Serious allergic or hypersensitivity reaction to a previous shot, or to any diphtheria or tetanus toxoid vaccine;
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Diphtheria and Tetanus Toxoid Absorbed vaccine;
- Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision to vaccinate an infant born prematurely should be careful based on both the possible benefits and potential risks of vaccination.

NVIC NOTE: Some doctors only vaccinate children and adults, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you or your child are sick and do not want to get vaccinated, but your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Diphtheria and Tetanus Toxoid Adsorbed. It is not known whether Diphtheria and Tetanus Toxoid Adsorbed can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Diphtheria and Tetanus Toxoid Adsorbed has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Adacel in Brief:

Ages: Adacel is a 3 in 1 shot (tetanus, diphtheria, and acellular pertussis) used as a booster dose (Tdap) for children and adults 10 years and older (see Sanofi Pasteur product insert for recommended schedule and other indications).
Vaccine Ingredients: Aluminum phosphate, formaldehyde, 2-phenoxyethanol, Stainer-Scholte medium, casamino acids, ammonium sulfate, modified Mueller’s growth medium, dimethyl-beta-cyclodextrin, glutaraldehyde, modified Mueller-Miller casamino acid medium without beef heart infusion.
Estimated Efficacy: Blood antibody responses to diphtheria toxoid vaccine were tested one month following administration of a single booster dose of Adacel in persons between the ages of 11 and 64 years. 99.8 percent of vaccine recipients aged 11 through 17 and 94.1 percent of vaccine recipients aged 18 through 64 were found to have blood antibody levels considered protective against diphtheria disease.
Use with Other Vaccines: In clinical trials, Adacel was given with hepatitis B or inactivated influenza vaccine. There is no information in the product insert about the safety or effectiveness of giving Adacel simultaneously with live influenza, meningococcal, HPV, MMR, varicella, hepatitis A, inactivated polio or other vaccines.
Commonly Reported Adverse Events: In clinical trials, the most common reactions were pain and swelling at the injection site; fever (especially in adolescents); headache; body aches/muscle weakness; fatigue; chills; sore and swollen joints; nausea; lymph node swelling.
Other Serious Reported Adverse Events: After licensure (post-marketing), adverse event reports have included severe injection site swelling, bruising, sterile abscess; facial palsy; convulsion; syncope (fainting); parasthesia; Guillain-Barre syndrome; myelitis; anaphylactic reaction; hypersensitivity reaction (angioedema, rash, hypotension); urticaria; muscle spasm; myocarditis.
Contraindications and precautions (Some reasons why Adacel should not be given to a child or adult – See Sanofi Pasteur product insert for complete list):
- Moderate or severe acute illness (with or without fever) until the illness resolves;
- Serious allergic or hypersensitivity reaction to a previous shot;
- Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within seven days of a previous pertussis vaccination not attributable to another identifiable cause;
- In adolescents, a progressive neurologic disorder, including progressive encephalopathy or uncontrolled epilepsy (convulsions);
- In adults, an unstable neurologic condition, such as cerebrovascular events and acute encephalopathic conditions;
- Severe allergic reaction to any component of Adacel;
- If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Adacel vaccine;
- Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive Adacel more frequently than every 10 years;
- The tip caps of prefilled Adacel syringes contain latex and may cause an allergic reaction in persons sensitive to latex.

There are no adequate and well-controlled studies on the administration of Adacel in pregnant women in the United States. It is not known whether Adacel vaccine components are excreted in human milk and there is no available data on the effect of administrating Adacel on breast-fed infants or on milk production/excretion. Adacel has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility.

About Boostrix Vaccine in Brief:

Ages: Boostrix is a 3 in 1 shot (tetanus, diphtheria, and acellular pertussis) used as a booster dose (Tdap) for children and adults 10 years and older (see GlaxoSmithKline product insert for recommended schedule and other indications).
Vaccine ingredients: Aluminum hydroxide, sodium chloride, polysorbate 80, modified Latham medium derived from bovine casein, Fenton medium containing a bovine extract, formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde.

Estimated Efficacy: Antibody responses to diphtheria were tested one month following administration of a single booster dose of Boostrix in adolescents between the ages of 10 and 18 years. 99.9 percent of vaccine recipients were found to have blood antibody levels considered protective against diphtheria. When tested one month following administration in persons between 19 and 64 years of age, 98.2 percent of vaccine recipients were noted to have blood antibody levels considered to be protective against diphtheria.

Use with Other Vaccines In clinical trials, Boostrix was given with inactivated influenza vaccine (Fluarix) and the meningococcal vaccine (Menactra). In both clinical trials, the antibody level for the pertussis component was determined to be lowered. There is no information in the product insert about the safety or effectiveness of giving Boostrix simultaneously with live influenza, MMR, varicella, HPV, hepatitis B, hepatitis A, inactivated polio or other vaccines.
Commonly Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site, increase in arm circumference of injected arm; headache; fatigue; gastrointestinal symptoms.
Other Serious Reported Adverse Events: One case of diabetes developed after Boostrix administration in clinical trials. After licensure (post marketing) adverse event reports have included extensive inflammation, swelling of injected limb; itching; encephalitis (brain inflammation); convulsion; facial palsy; lymphadenitis; lymphadenopathy; myocarditis; arthralgia; back pain; myalgia; urticaria; Henoch-Schonlein purpura.
Contraindications and precautions (Some reasons why Boostrix should not be given to a child or adult – See GlaxoSmithKline product insert for complete list):
- Serious allergic or hypersensitivity reaction to a previous shot;
- Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within seven days of a previous pertussis vaccination not attributable to another identifiable cause;
- In adolescents and adults, a progressive neurologic disorder, including progressive encephalopathy or uncontrolled epilepsy (convulsions);
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Boostrix vaccine;
- Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive Boostrix more frequently than every 10 years;
- The tip caps of prefilled Boostrix syringes contain latex and may cause an allergic reaction in persons sensitive to latex.

Animal reproduction studies have not been conducted with Boostrix. It is not known whether Boostrix can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Boostrix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. There are no adequate and well-controlled studies on the administration of Boostrix in pregnant women in the United States.

About TDVAX Vaccine in Brief:

Ages: TDVAX is a 2 in 1 shot (tetanus and diphtheria) for persons over the age of seven (see MassBiologics product insert for recommended schedule and other indications).
Vaccine Ingredients: Thimerosal, aluminum phosphate, formaldehyde, modified Mueller's media which contains bovine extracts.

Estimated Efficacy: Efficacy of diphtheria toxoid in TDVAX was based on immunogenicity (blood immune response) of six vaccine recipients tested after three doses of TDVAX were given as a primary series. All vaccine recipients were noted to have blood antibody levels considered protective against diphtheria. When administered as a booster dose, all 140 adolescent male vaccine recipients tested were noted to have blood antibody levels believed to be protective against diphtheria.

Use with Other Vaccines: No clinical trials examined the safety or effectiveness of administering the vaccine with any other U.S. licensed vaccine.
Commonly Reported Adverse Events: There is no pre-licensing clinical trial data on adverse events following TDVAX in the vaccine package insert.
Other Serious Reported Adverse Events: After licensure (post marketing) adverse event reports have included injection site pain, swelling, warmth, itching and hypersensitivity; fever; cellulitis; nausea; rash; joint and muscle pain; dizziness; convulsion; malaise; headache.
Contraindications and precautions (Some reasons why TDVAX should not be given to a child or adult – See MassBiologics product insert for complete list):
- Serious allergic or hypersensitivity reaction to a previous shot, or to any diphtheria or tetanus toxoid vaccine;
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering TDVAX vaccine;
- Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive TDVAX more frequently than every 10 years.

Animal reproduction studies have not been conducted with TDVAX. It is not known whether TDVAX can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TDVAX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About TENIVAC Vaccine in Brief:

Ages: TENIVAC is a 2 in 1 shot (tetanus and diphtheria) for persons over the age of seven (see Sanofi Pasteur product insert for recommended schedule and other indications).
Vaccine Ingredients: Aluminum phosphate, formaldehyde, ammonium sulfate, sodium chloride, modified Mueller-Miller casamino acid medium without beef heart infusion, water.

Estimated Efficacy: Efficacy of diphtheria toxoid in TENIVAC was based on evaluation of immunogenicity (blood immune response) in 17 vaccine recipients tested after two and three doses of TENIVAC given as a primary series. All vaccine recipients were noted to have blood antibody levels considered to be protective against diphtheria four weeks following the third dose of TENIVAC. When administered as a booster dose, 100 percent of persons between the ages of 11-18 years, 99.2 percent of adults between 19 and 59 years of age and 88.0 percent of adults 60 years of age and older were noted to have the minimally acceptable blood antibody levels believed to be protective against diphtheria.

Use with Other Vaccines: No clinical trials examined the safety or effectiveness of administering the vaccine with any other U.S. licensed vaccine.
Commonly Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site; fever; muscle weakness; joint pain; malaise; headache.
Other Serious reported Adverse Events: In pre-licensing clinical trials, serious adverse events included asthma, localized infection, stroke, chest pain, colonic polyp, cellulitis, angina pectoris, hip and wrist fracture, and cholecystitis. Three deaths occurred following administration of TENIVAC. Deaths were reported as cardiopulmonary arrest; myocardial infarction and septic shock; and unknown cause. After licensure (post marketing) adverse event reports have included Guillain-Barre Syndrome (GBS), injection site pain, swelling, warmth, itching, cellulitis and hypersensitivity; fever; lymphadenopathy; vomiting; dizziness; paresthesia; syncope; fatigue; peripheral edema; rash; joint and muscle pain; allergic and anaphylactic reactions.
Contraindications and precautions (Some reasons why TENIVAC should not be given to a child or adult – See Sanofi Pasteur product insert for complete list):
- Serious allergic or hypersensitivity reaction to a previous shot, or to any diphtheria or tetanus toxoid vaccine;
- If Guillain-Barré syndrome (GBS) occurred within six weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering TENIVAC vaccine;
- Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive TDVAX more frequently than every 10 years;
- The tip caps of prefilled TENIVAC syringes contain latex and may cause an allergic reaction in persons sensitive to latex;
- Administering TENIVAC vaccine more frequently than prescribed may result in an increased incidence and severity of adverse reactions.

Animal reproduction studies have not been conducted with TENIVAC. It is not known whether TENIVAC can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TENIVAC has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Diphtheria and the Diphtheria vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.