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Vaccine Comparison

Adacel Boostrix DAPTACEL DECAVAC Diphtheria and Tetanus Toxoids Adsorbed Infanrix KINRIX Pediarix Pentacel TENIVAC Tripedia
Vaccine Information Vaccine Information Vaccine Information Vaccine Information Vaccine Information Vaccine Information Vaccine Information Vaccine Information Vaccine Information Vaccine Information Vaccine Information
  • Product Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
  • Tradename: Adacel
  • Manufacturer: Sanofi Pasteur, Ltd (USA: License #1726)
  • Vaccine Ontology ID: VO_0000005
  • CDC CVX code: 20, 115
  • Type: Toxoid vaccine
  • Status: Licensed
  • Location Licensed: USA: License #1726
  • Host Species for Licensed Use: Human
  • Antigen: Pertussis
  • Adjuvant: aluminum phosphate vaccine adjuvant
    • VO ID: VO_0000128
    • Description: It is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.
  • Preparation: Corynebacterium diphtheriae is grown in modified Mueller‘s growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Diphtheria toxoid is adsorbed onto aluminum phosphate (Adacel).
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Adacel vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE
  • Approved Age for Licensed Use: Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age.
  • Contraindication: A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Adacel vaccine or any other tetanus toxoid, diphtheria toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication to vaccination with Adacel vaccine (Adacel).
  • Description: It is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.
  • Product Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
  • Tradename: Boostrix
  • Manufacturer: GlaxoSmithKline Biologicals
  • Vaccine Ontology ID: VO_0000015
  • CDC CVX code: 20, 115
  • Type: Toxoid vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1617)
  • Host Species for Licensed Use: Human
  • Adjuvant: aluminum phosphate vaccine adjuvant
    • VO ID: VO_0000128
    • Description: BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens (Boostrix).
  • Preparation: Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking.
    The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. The bovine materials used in this extract are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). The diphtheria toxin is detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration .
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.
  • Approved Age for Licensed Use: BOOSTRIX is a vaccine indicated for active booster immunization against tetanus, diphtheria, and pertussis as a single dose. BOOSTRIX is approved for use in individuals 10 through 64 years of age (Boostrix).
  • Contraindication: A severe allergic reaction after a previous dose of any tetanus toxoid-diphtheria toxoid or pertussis antigen containing vaccine or any component of this vaccine is a contraindication to administration of BOOSTRIX (Boostrix).
  • Description: BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens (Boostrix).
  • Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
  • Tradename: DAPTACEL
  • Manufacturer: Sanofi Pasteur, Ltd.
  • Vaccine Ontology ID: VO_0000029
  • CDC CVX code: 20, 106
  • Type: Toxoid vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1726)
  • Host Species for Licensed Use: Human
  • Adjuvant: aluminum hydroxide vaccine adjuvant
    • VO ID: VO_0000127
    • Description: DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age.
  • Preparation: DAPTACEL vaccine is a sterile isotonic suspension of pertussis antigens and diphtheria toxoids adsorbed on aluminum phosphate. Corynebacterium diphtheriae is grown in modified Mueller’s growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered (FDA: DAPTACEL).
  • Storage: DAPTACEL vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE
  • Approved Age for Licensed Use: DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age (prior to 7th birthday) (FDA: DAPTACEL).
  • Contraindication: Severe allergic reaction (e.g. anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, or any component of DAPTACEL, encephalopathy within 7 days of a previous pertussis-containing vaccine with no other identifiable cause and, progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized (FDA: DAPTACEL).
  • Description: DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age.
  • Product Name: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
  • Tradename: DECAVAC
  • Manufacturer: Sanofi Pasteur, Inc
  • Vaccine Ontology ID: VO_0000030
  • CDC CVX code: 113
  • Type: Toxoid vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1725)
  • Host Species for Licensed Use: Human
  • Adjuvant: aluminum potassium sulfate adjuvant
    • VO ID: VO_0001240
    • Description: It is for intramuscular injection, and is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution (Decavac).
  • Preparation: The cultures are grown in a modified Mueller and Miller medium. Diphtheria toxins produced during the growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration, and adsorbed onto alum. (FDA: Decavac).
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Store at 2° to 8°C (35° to 46°F). Do not freeze. Do not use vaccine after expiration date.
  • Approved Age for Licensed Use: DECAVAC vaccine is indicated for active immunization for the prevention of tetanus and diphtheria. DECAVAC vaccine is approved for use in persons 7 years of age and older (FDA: Decavac).
  • Contraindication: Do not use after anaphylaxis or other serious allergic reaction following a previous dose of this vaccine, any other tetanus or diphtheria toxoid containing vaccine, or any component of this vaccine
  • Description: It is for intramuscular injection, and is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution (FDA: Decavac).
  • Product Name: Diphtheria and Tetanus Toxoids Adsorbed
  • Tradename: None
  • Manufacturer: Sanofi Pasteur Inc
  • Vaccine Ontology ID: VO_0000033
  • CDC CVX code: 28
  • Type: Inactivated or "killed" vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1725), Canada
  • Host Species for Licensed Use: Human
  • Adjuvant: aluminum potassium sulfate adjuvant
  • Preparation: The vaccine is grown in a peptone-based medium containing bovine extract. The meat used in this medium is US sourced. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration.
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
  • Approved Age for Licensed Use: 6 weeks to 6 years of age
  • Contraindication: Hypersensitivity to any component of the vaccine, including thimerosal, a mercury derivative, is a contraindication for further use of this vaccine. It is a contraindication to use this or any other related vaccine after an immediate anaphylactic reaction associated with a previous dose (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).
  • Description: The primary series of vaccination for infants 6 weeks through 12 months, consists of 4 doses: administer three 0.5 mL doses intramuscularly 4 to 8 weeks apart. A reinforcing dose is given 6 to 12 months after the third injection (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).
  • Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
  • Tradename: Infanrix
  • Manufacturer: GlaxoSmithKline Biologicals
  • Vaccine Ontology ID: VO_0000064
  • CDC CVX code: 20
  • Type: Inactivated or "killed" vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1617)
  • Host Species for Licensed Use: Human
  • Adjuvant: aluminum hydroxide vaccine adjuvant
    • VO ID: VO_0000127
    • Description: INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a 5-dose series in infants and children 6 weeks to 7 years of age. INFANRIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA: INFANRIX).
  • Preparation: The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract.
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Store INFANRIX refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.
  • Approved Age for Licensed Use: INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a 5-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday). Because of the substantial risks of complications from pertussis disease in infants, completion of the primary series of 3 doses of vaccine early in life is strongly recommended. INFANRIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older. When passive protection against tetanus or diphtheria is required, Tetanus Immune Globulin or Diphtheria Antitoxin, respectively, should be administered at separate sites (FDA: INFANRIX).
  • Contraindication: Hypersensitivity to any component of the vaccine and ti should not be administered to anyone with a known previous allergic reaction associated with the vaccine (FDA: INFANRIX).
  • Description: INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a 5-dose series in infants and children 6 weeks to 7 years of age. INFANRIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA: INFANRIX).
  • Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
  • Tradename: KINRIX
  • Manufacturer: GlaxoSmithKline Biologicals
  • Vaccine Ontology ID: VO_0000067
  • CDC CVX code: 130
  • Type: Inactivated or "killed" vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1617)
  • Host Species for Licensed Use: Human
  • Antigen: Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussin toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) (FDA: KINRIX).

    The diphtheria, tetanus, and pertussis components of KINRIX are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX.
  • Adjuvant: aluminum hydroxide vaccine adjuvant
    • VO ID: VO_0000127
    • Description: A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first three doses and INFANRIX for the fourth dose (FDA: KINRIX).
  • Preparation: The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. After, they are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration (FDA: KINRIX).
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.
  • Approved Age for Licensed Use: A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first three doses and INFANRIX for the fourth dose (FDA: KINRIX).
  • Contraindication: A severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, pertussis or poliovirus-containing vaccine, or to any component of KINRIX, including neomycin and polymyxin B, encephalopathy within 7 days of administration of a previous pertussis-containing vaccine and progressive neurologic disorders (FDA: KINRIX).
  • Description: A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first three doses and INFANRIX for the fourth dose (FDA: KINRIX).
  • Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
  • Tradename: Pediarix
  • Manufacturer: GlaxoSmithKline Biologicals
  • Vaccine Ontology ID: VO_0000082
  • CDC CVX code: 110
  • Type: Inactivated or "killed" vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1617)
  • Host Species for Licensed Use: Human
  • Adjuvant: aluminum hydroxide vaccine adjuvant
    • VO ID: VO_0000127
    • Description: It contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett) (FDA: Pediarix).
  • Allergen: yeast, neomycin,polymyxin B
  • Preparation: The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. The diphtheria, tetanus, and pertussis antigens are individually adsorbed onto aluminum hydroxide then diluted and combined to produce the final formulated vaccine (FDA: Pediarix).
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: The vaccine should be refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.
  • Approved Age for Licensed Use: PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 as a three-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age. PEDIARIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA: Pediarix).
  • Contraindication: Hypersensitivity to any component of the vaccine, including yeast, neomycin, and polymyxin B, the vaccine should also not be administered to anyone with a previous allergic reaction to a dose of the vaccine (FDA: Pediarix).
  • Description: It contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett) (FDA: Pediarix).
  • Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
  • Tradename: Pentacel
  • Manufacturer: Sanofi Pasteur Limited
  • Vaccine Ontology ID: VO_0000084
  • CDC CVX code: 120
  • Type: Subunit vaccine + Inactivated or "killed" vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1726), Canada
  • Host Species for Licensed Use: Human
  • Adjuvant: aluminum phosphate vaccine adjuvant
    • VO ID: VO_0000128
    • Description: It consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® vaccine component. Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b (FDA: Pentacel).
  • Preservative: 2 phenoxy ethanol
  • Allergen: Polymyxin B, Neomycin
  • Preparation: Corynebacterium diphtheriae is grown in modified Mueller’s growth medium. After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. (FDA: Pentacel).
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Store at 2° to 8°C (35° to 46°F). Do not freeze.
  • Approved Age for Licensed Use: 6 weeks to 4 years of age.
  • Contraindication: A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Pentacel vaccine, any ingredient of this vaccine, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine or H influenzae type b vaccine is a contraindication. (FDA: Pentacel).
  • Description: It consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® vaccine component. Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b (FDA: Pentacel).
  • Product Name: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
  • Tradename: TENIVAC
  • Manufacturer: Sanofi Pasteur, Ltd
  • Vaccine Ontology ID: VO_0000102
  • Type: Toxoid vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1726)
  • Host Species for Licensed Use: Human
  • Adjuvant: aluminum phosphate vaccine adjuvant
    • VO ID: VO_0000128
    • Description: Is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older (Tenivac).
  • Preparation: Corynebacterium diphtheriae is grown in modified Mueller’s 223 growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is 224 detoxified with formaldehyde and diafiltered.(Tenivac)
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: TENIVAC vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
  • Approved Age for Licensed Use: TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older (Tenivac).
  • Contraindication: Severe allergic reaction (e.g., anaphylaxis) to a previous dose of TENIVAC, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication.(Tenivac)
  • Description: Is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.(Tenivac)
  • Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
  • Tradename: Tripedia
  • Manufacturer: Sanofi Pasteur, Inc.
  • Vaccine Ontology ID: VO_0000112
  • CDC CVX code: 20
  • Type: Toxoid vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1725)
  • Host Species for Licensed Use: Human
  • Adjuvant: aluminum potassium sulfate adjuvant
    • VO ID: VO_0001240
    • Description: Tripedia vaccine combines diptheria and tetanus toxoids with purified pertussis antigens. It consists of 3 doses administered at intervals of 4-8 weeks (FDA: Tripedia).
  • Preparation: Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium. It is detoxified with formaldehyde and then seperately purified by serial ammonium sulfate fractionation and diafiltration (FDA: Tripedia).
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Store between 2 and 8 degrees Celsius. DO NOT FREEZE.
  • Approved Age for Licensed Use: Tripedia vaccine is indicated for active immunization against diphtheria, tetanus, and pertussis simultaneously in infants and children 6 weeks to 7 years of age (prior to seventh birthday) (FDA: Tripedia).
  • Contraindication: This vaccine should not be administered to anyone with a known hypersensitivity to any component of the vaccine.
  • Description: Tripedia vaccine combines diptheria and tetanus toxoids with purified pertussis antigens. It consists of 3 doses administered at intervals of 4-8 weeks (FDA: Tripedia).
Host Response Host Response Host Response Host Response Host Response Host Response Host Response Host Response Host Response Host Response Host Response

Human Response

  • Vaccination Protocol: The principal immunogenicity study was a comparative, multi-center, randomized, observer blind, controlled trial which enrolled 4,480 participants; 2,053 adolescents (11-17 years of age). and 2,427 adults (18-64 years of age). Enrollment was stratified by age to ensure adequate representation across the entire age range. Participants had not received a tetanus or diphtheria toxoid containing vaccine within the previous 5 years (Adacel).
  • Immune Response: Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response. (Adacel)
  • Side Effects: A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Adacel vaccine. Also, headache, body ache or muscle weakness, tiredness, chills, sore and swollen joints, nausea, lymph node swelling, diarrhea, vomiting, and rash may result (Adacel).

Human Response

  • Vaccination Protocol: In a randomized, observer-blinded, controlled study in the US, 3,080 adolescents 10 to 18 years of age received a single dose of BOOSTRIX and 1,034 received the control Td vaccine (Boostrix).
  • Immune Response: Prior to vaccination, antibody levels in subjects were 85.8% while after vaccination were 99.9% (Boostrix).
  • Side Effects: Common solicited adverse events (≥15%) in adolescents were pain, redness, and swelling at the injection site, increase in arm circumference of injected arm, headache, fatigue, and gastrointestinal symptoms.(Boostrix)

Human Response

  • Vaccination Protocol: In a randomized, double-blinded pertussis vaccine efficacy trial, the Sweden I Efficacy Trial, conducted in Sweden during 1992-1995, the safety of DAPTACEL vaccine was compared with DT and a whole-cell pertussis DTP vaccine. A standard diary card was kept for 14 days after each dose and follow-up telephone calls were made 1 and 14 days after each injection. Telephone calls were made monthly to monitor the occurrence of severe events and/or hospitalizations for the 2 months after the last injection (FDA: DAPTACEL).
  • Immune Response: One clinical study found that among a random subset of children who received the fourth dose of DAPTACEL vaccine at 15-16 months of age, 96.5% achieved diphtheria antitoxin levels of ≥1.0 IU/mL after the fourth dose (FDA: DAPTACEL).
  • Side Effects: Side effects of vaccination are: injection site reactions, irritability, fussiness, and lethargy.

Human Response

  • Vaccination Protocol: A clinical study involving 58 individuals 6-58 years of age (FDA: Decavac).
  • Side Effects: Side effects include: erythema, tenderness and induration at the injection site and 2% systemic reactions consisting of headache, malaise and temperature elevations. Boosters can accentuate side effects(FDA: Decavac)
  • Efficacy: The results that indicated protective levels of antibody were achieved in greater than 90% of the study population after primary immunization with both components. Booster effects were achieved in 100% of the individuals with pre-existing antibody responses (FDA: Decavac).

Human Response

Human Response

  • Vaccination Protocol: Efficacy of diphtheria toxoid used in INFANRIX was determined on the basis of immunogenicity studies (FDA: INFANRIX).
  • Side Effects: Side effects of vaccination include: injection site reactions, fever, irritability, drowsiness, loss of appetite, and vomiting (FDA: INFANRIX).
  • Efficacy: A VERO cell toxin neutralizing test confirmed the ability of infant sera, obtained 1 month after a 3-dose primary series, to neutralize diphtheria toxin. Levels of diphtheria antitoxin were achieved in 100% of the sera tested (FDA: INFANRIX).

Human Response

  • Vaccination Protocol: The primary study (Study 048), conducted in the United States, was a randomized, controlled clinical trial in which children 4 to 6 years of age were vaccinated with KINRIX (N = 3,156) or control vaccines (INFANRIX and IPOL® vaccine [IPV, Sanofi Pasteur SA]; N = 1,053) as a fifth DTaP vaccine dose following 4 doses of INFANRIX and as a fourth IPV dose following 3 doses of IPOL (FDA: KINRIX).
  • Immune Response: After vaccination, antibody levels in clinical trials was determined to be between 85-100% for all subjects (FDA: KINRIX).
  • Side Effects: The most common side effects reported were: injection site reactions, fever, drowisness, and loss of appetite (FDA: KINRIX).

Human Response

  • Vaccination Protocol: A double-blind, randomized, active Diphtheria and Tetanus Toxoids (DT)-controlled trial conducted in Italy, sponsored by the National Institutes of Health (NIH), assessed the absolute protective efficacy of INFANRIX when administered at 2, 4, and 6 months of age (FDA: Pediarix).
  • Immune Response: In response to vaccination, all patients seem to have around 90-100% antibody response.
  • Side Effects: The most reported side effects included: injection site reactions, fever, drowsiness, loss of appetite and fussiness (FDA: Pediarix).

Human Response

  • Vaccination Protocol: A clinical study looked at anti-PRP seroprotection rates and GMCs one month following Dose 3 of Pentacel vaccine or separately administered ActHIB vaccine in studies P3T06 and M5A10 (FDA: Pentacel).
  • Immune Response: After vaccination, subjects achieved 90% or greater anti-PRP ≥0.15 μg/mL (FDA: Pentacel).
  • Side Effects: Injection site reactions include: Redness, swelling, tenderness, and an increase in arm circumference. The Systemic reactions include: fever, decreased activity, inconsolable crying, and irritability. (FDA: Pentacel).

Human Response

  • Vaccination Protocol: A clinical study evaluated 17 participants ages 6 to 56 years conducted in Canada (Tenivac).
  • Immune Response: Four weeks following the second dose, all 17 participants had a serum diphtheria antitoxin level ≥0.01 IU/mL. Four weeks following the third dose, all 17 participants had a serum diphtheria antitoxin level >0.1 IU/mL (Tenivac).
  • Side Effects: The most frequent solicited injection site reaction within 0-3 days following TENIVAC was pain, reported in 78.3% of study participants 11-59 years of age and 35.3% of participants ≥60 years of age. Contraindicatons include pain, redness, swelling, and systemic adverse effects (Tenivac).

Human Response

  • Side Effects: Side effects of vaccination include: injection site reactions, fevver, irritability, drowsiness, and vomiting. In some cases with infant immunization, anorexia and an unusual hig-pitched cry were reported (FDA: Tripedia).
  • Efficacy: Complete immunization significantly reduces the risk of developing diptheria and protection lasts around 10 years.
References References References References References References References References References References References
Adacel: Adacel [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm172481.htm]
Boostrix: Boostrix [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm172925.htm]
FDA: DAPTACEL: FDA: DAPTACEL Vaccine [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101572.htm]
FDA: Decavac: Decavac [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094067.htm]
FDA: Diphtheria and Tetanus Toxoids Adsorbed: FDA: Diphtheria and Tetanus Toxoids Adsorbed [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142732.pdf]
FDA: INFANRIX: FDA: INFANRIX [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101568.htm]
FDA: KINRIX: FDA: KINRIX Vaccine [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM241453.pdf]
FDA: Pediarix: FDA: Pediarix [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm146759.htm]
FDA: Pentacel: FDA: Pentacel Vaccine [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM109810.pdf]
FDA: TENIVAC: FDA: TENIVAC vaccine information [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM152826.pdf]
FDA: Tripedia: FDA: Tripedia [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101565.htm]