PEDIARIX™ [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] is a noninfectious, sterile, multivalent vaccine for intramuscular administration manufactured by GlaxoSmithKline Biologicals. It contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT], 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). The diphtheria toxoid, tetanus toxoid, and pertussis antigens are the same as those in INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). The hepatitis B surface antigen is the same as that in ENGERIX-B® [Hepatitis B Vaccine (Recombinant)].
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.
Infants born of HBsAg-positive mothers should receive Hepatitis B Immune Globulin (Human) (HBIG) and monovalent Hepatitis B Vaccine (Recombinant) within 12 hours of birth and should complete the hepatitis B vaccination series according to a particular schedule.36(See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]) (see DOSAGE AND ADMINISTRATION).
Infants born of mothers of unknown HBsAg status should receive monovalent Hepatitis B Vaccine (Recombinant) within 12 hours of birth and should complete the hepatitis B vaccination series according to a particular schedule.36(See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]) (see DOSAGE AND ADMINISTRATION).
PEDIARIX will not prevent hepatitis caused by other agents, such as hepatitis A, C, and E viruses, or other pathogens known to infect the liver. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, hepatitis D will also be prevented by vaccination with PEDIARIX.
Hepatitis B has a long incubation period. Vaccination with PEDIARIX may not prevent hepatitis B infection in individuals who had an unrecognized hepatitis B infection at the time of vaccine administration.
When passive protection against tetanus or diphtheria is required, Tetanus Immune Globulin or Diphtheria Antitoxin, respectively, should be administered at separate sites.1
As with any vaccine, PEDIARIX may not protect 100% of individuals receiving the vaccine, and is not recommended for treatment of actual infections.
Published Studies Related to Pediarix (Diphtheria / Tetanus / Pertussis / Hepatitis B / Poliovirus)
Immunogenicity and reactogenicity of two regimens of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio and Haemophilus influenzae type b vaccines administered to infants primed at birth with hepatitis B vaccine. [2004.09]
An open, randomized study evaluated the immune response and safety of two different regimens of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b (DTPa-HBV-IPV-Hib) immunization in infants primed at birth with hepatitis B vaccine.The most frequently reported post-vaccination symptoms were irritability in the DTPa-IPV-Hib plus separate HBV group (49% of vaccinees) and fever, defined as axillary temperature > or =37.5 degrees C, in the DTPa HBV- IPV-Hib group (50% of vaccinees).
Safety, reactogenicity and immunogenicity of a combined hexavalent tetanus, diphtheria, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b conjugate vaccine, for primary immunization of infants. [2004.06.02]
Safety, reactogenicity and immunogenicity of GSK Biologicals' hexavalent DTPa-HBV-IPV/Hib vaccine (Infanrix)hexa) was assessed when used for primary vaccination at 3, 4 and 5 months of age (N = 2163), compared to the separate administration of DTPa-IPV/Hib and HBV vaccines (N = 720).By offering protection against six diseases in a series of single injections, the hexavalent DTPa-HBV-IPV/Hib vaccine was shown to be a safe, well tolerated and immunogenic alternative to primary immunization with licensed separately administered vaccines.
Comparison of the reactogenicity and immunogenicity of a combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) vaccine, mixed with the Haemophilus influenzae type b (Hib) conjugate vaccine and administered as a single injection, with the DTPa-IPV/Hib and hepatitis B vaccines administered in two simultaneous injections to infants at 2, 4 and 6 months of age. [2003.09.08]
An open, randomised, multicentre trial was performed to compare the reactogenicity and safety profile of the administration of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio (DTPa-HBV-IPV) vaccine administered in one injection mixed with Haemophilus influenzae type b (Hib) conjugate vaccine (Group 1) with that of a pentavalent DTPa-IPV vaccine mixed with a Hib vaccine (DTPa-IPV/Hib), simultaneously administered with HBV (Group 2) in two injections in opposite thighs, as a primary vaccination course, to healthy infants at 2, 4 and 6 months of age...
Simultaneous administration of meningococcal C conjugate vaccine and diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine in children: a randomized double-blind study. [2002.12]
BACKGROUND: Meningococcal C disease can be life-threatening in infants, young children and adolescents. New conjugate vaccines are immunogenic in young infants and induce immunologic memory, so we should consider incorporating them into the routine childhood immunization program. The objective of this study was to measure the safety and immunogenicity of a meningococcal C conjugate vaccine when given with routine childhood vaccines... CONCLUSIONS: The meningococcal C conjugate vaccine can be safely and effectively administered at the same visit as the other vaccine antigens routinely given to infants in Canada.
Impact of a birth dose of hepatitis B vaccine on the reactogenicity and immunogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b combination vaccination. [2002.09]
OBJECTIVES: To assess the impact of a birth dose of hepatitis B vaccine (HepB) on the reactogenicity and immunogenicity of a novel diphtheria-tetanus-acellular pertussis (DTaP)- HepB-inactivated poliovirus (IPV)/ type b (Hib) combination vaccine administered subsequently at 2, 4 and 6 months of age... CONCLUSIONS: A HepB birth dose does not increase the reactogenicity of a combination DTaP-HepB-IPV/Hib vaccine administered at 2, 4 and 6 months of age, and all tested subjects achieved protective anti-HBs titers (> or =10 mIU/ml), although geometric mean titers were higher when a birth dose of HepB was given.
Clinical Trials Related to Pediarix (Diphtheria / Tetanus / Pertussis / Hepatitis B / Poliovirus)
Post-Marketing Safety Study of GSK Biological's Pediarixâ¢ Vaccine. [Active, not recruiting]
Pre-licensure studies of GSK Biologicals' PEDIARIX vaccine have shown it to be generally safe
and unlikely to result in vaccine-associated serious adverse events. This post-licensure
study is designed to evaluate relatively uncommon/rare outcomes in a large population
Pentavalent DTaP-Hep B-IPV [Completed]
The purpose of this study is to evaluate the safety of administering a combination vaccine
(DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration
of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age.
Additionally, researchers will assess the body's antibody response (proteins produced by the
body's immune system that help fight infections) following each vaccine dose. The study will
enroll 5 healthy newborns, ages 0-5 days. Participants will be involved in study related
procedures for up to 280 days, including blood sample collection and 5 study visits.
Database Surveillance Safety Study of PENTACELï¿½ Vaccine [Recruiting]
The objective for this study is to characterize the safety profile of PENTACEL® vaccine for
identification of potential vaccine-related adverse events not currently associated with
PENTACEL® vaccine administration.
Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate Vaccine & Compared to Licensed Meningococcal Serogroups A,C,W,Y Vaccine [Completed]
This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a
control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6
months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135
polysaccharide vaccine administered at 3 to 5 years of age. The safety and immunogenicity of
a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib
conjugate vaccine, each administered at 12 to 15 months of age.
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA [Completed]
The aim of this this study is to confirm absence of immune interference between HRV vaccine
and routine infant vaccinations currently in use in the USA.
Page last updated: 2006-01-31