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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.
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.
Diphtheria Toxoid Vaccines Licensed for Use in the U.S.
The U.S. Food and Drug Administration has approved eleven different combination vaccine that include diphtheria toxoid vaccine; There are different rules for use of these vaccines by different age groups.
Package inserts for each vaccine are located on the Diphtheria Quick Facts Page.
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.
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.
Infanrix is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis vaccine) given to infants and children 6 weeks through 6 years of age. (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.
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.
DAPTACEL is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis vaccines) given to infants and children 6 weeks though 6 years of age. (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.
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.
Pediarix is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio and recombinant hepatitis B vaccines) given to infants and children 6 weeks through 6 years of age. (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.
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.
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.
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.
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.
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.
Pentacel is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae b conjugate vaccines) for infants and children 6 weeks through four years of age. (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
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.
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.
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.
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.
Adacel has not been studied for carcinogenic or mutagenic potential, or impairment of male fertility.
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.
BOOSTRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. Female rats and rabbits vaccinated with BOOSTRIX was reported to have no effect on fertility.
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.
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.
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: The efficacy of diphtheria toxoid in TENIVAC was based on the 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.
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.