INFANRIX SUMMARY
INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile combination of diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (69 kiloDalton outer membrane protein)] adsorbed onto aluminum hydroxide. INFANRIX is intended for intramuscular injection only.
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 (see DOSAGE AND ADMINISTRATION). 1 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. 1
As with any vaccine, INFANRIX may not protect 100% of individuals receiving the vaccine, and is not recommended for treatment of actual infections.
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NEWS HIGHLIGHTS
Published Studies Related to Infanrix (Diphtheria / Tetanus / Pertussis)
Safety and immunogenicity of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 3, 4, and 12-14 months of age. [2009.04.28]
Combination vaccines improve parental and provider satisfaction and schedule compliance by decreasing the number of injections. In a Phase 2, randomized, double-blind, multicenter study, we compared four formulations of a liquid, hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B virus (DTaP-IPV-Hib-HBV) vaccine in 708 infants immunized at 2, 3, 4, and 12-14 months of age...
Booster vaccination of toddlers with reduced antigen content diphtheria -- tetanus -- acellular pertussis vaccine. [2009.04.21]
Immunogenicity and reactogenicity of DTPa and reduced antigen dTpa booster vaccines were compared to a hepatitis A control vaccine in DTPa-primed toddlers aged 18 - 20 months. Post-booster, all DTPa and dTpa recipients were seroprotected against diphtheria and tetanus, and > or = 93.3% had a booster response to pertussis...
Concomitant use of the 3-dose oral pentavalent rotavirus vaccine with a 3-dose primary vaccination course of a diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b vaccine: immunogenicity and reactogenicity. [2009.03]
BACKGROUND: The pentavalent rotavirus vaccine (PRV), RotaTeq, can be concomitantly administered with most routine childhood vaccines. This study evaluated the immunogenicity and reactogenicity of PRV when used concomitantly with a hexavalent vaccine containing diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b... CONCLUSIONS: In this study, concomitant administration of PRV with hexavalent vaccine was well tolerated and the immune responses to the antigens of the hexavalent vaccine were noninferior when compared with those of the control group. In addition, PRV was immunogenic when administered concomitantly with hexavalent vaccine.
Booster vaccination of adults with reduced-antigen-content diphtheria, Tetanus and pertussis vaccine: immunogenicity 5 years post-vaccination. [2009.02.11]
At 60 months post-vaccination, adults (mean age 45.6 years) randomised to receive combined reduced-antigen-content diphtheria-tetanus and acellular pertussis vaccine (dTpa) versus tetanus-diphtheria (Td)+monovalent acellular pertussis (pa) were seroprotected against diphtheria (> or =0.016IU/mL Vero cell assay) and tetanus (> or =0.1IU/mL ELISA assay) in 94.4% and 96.2%, respectively (dTpa), compared with 93.7% and 90.6% (Td+pa).
Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age. [2009.01.29]
PURPOSE: This study was conducted to assess the immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine containing three pertussis antigens (Boostrix, Tdap3v), currently licensed in the US for use in adolescents 10-18 years of age, in adults 19-64 years of age... CONCLUSION: In adult recipients, Tdap3v was comparable to an approved Tdap vaccine in providing seroprotection against diphtheria and tetanus, and produced immune responses to pertussis antigens consistent with protection against disease. The overall safety profile of Tdap3v was generally comparable to that of Tdap5v [NCT #106316].
Clinical Trials Related to Infanrix (Diphtheria / Tetanus / Pertussis)
Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines. [Completed]
To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK
Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months
old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded
for the two DTP vaccines and single blinded for the control arm.
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants [Active, not recruiting]
The purpose of the study is to provide immunogenicity and safety data of the investigational
hexavalent vaccine when it is given concomitantly (the same day at separate injection sites)
with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB
vaccine at birth.
Primary Objective:
To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune
response that is at least as good as the response following Infanrix™-Hexa in terms of
seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6
months), when co-administered with Prevnar®
Secondary Objectives:
Immunogenicity:
To describe in each group the immunogenicity parameters to each vaccine component (for
DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series.
Safety:
To describe the overall safety after each injection.
Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers [Active, not recruiting]
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants
and toddlers when given at 2,3,4 and 12-18 months of age.
Primary Objectives:
- To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both
are co-administered with Prevenar®.
- To describe the post-dose 3 pertussis antibody responses.
Secondary Objectives:
- To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both
are co-administered with Prevenar®.
- To describe the safety after each vaccination following co-administration with
Prevenar®.
Safety and Immunogenicity of a New Serum-Free DTaP-IPVvero Combination Vaccine [Completed]
The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial
investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:
A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line
(DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney
cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5,
and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection
in the opposite thigh.
Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for
antibodies against diphtheria, tetanus, pertussis, polio and prp.
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine [Completed]
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety
and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.
Stage I Primary Objectives:
1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered
with other recommended vaccines.
2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of
DAPTACEL when co-administered with other recommended vaccines.
3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB
concurrently administered in a different injection site with DAPTACEL when these
vaccines are co-administered with other recommended vaccines.
Stage II Primary Objectives:
1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib
or other infant vaccines.
2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when
co-administered with ActHIB in toddlers.
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