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.
|
NEWS HIGHLIGHTS
Published Studies Related to Infanrix (Diphtheria / Tetanus / Pertussis)
An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children. [2011.06.06]
Tetravalent meningococcal serogroups ACWY conjugate vaccines will provide an advantage to those at most risk of invasive meningococcal disease; namely young children. Co-administration of ACWY-TT with DTaP-HBV-IPV/Hib was assessed in a randomized trial in 793 children aged 12-23 months.ACWY-TT and DTaP-HBV-IPV/Hib co-administration during the second year would facilitate introduction of ACWY-TT into routine toddler vaccination schedules.
Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. [2011.06]
BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 mug Hansenula polymorpha-derived recombinant hepatitis B (Hep B) surface antigen, Sanofi Pasteur, in Argentinean infants... CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) is highly immunogenic and safe when compared with licensed comparators, warranting further development.
Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China. [2011.02.24]
The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim((R))) compared to individual vaccines in infants in the People's Republic of China. Infants (N=792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib((R))) and IPV (Imovax((R)) Polio) at 3, 4 and 5 months of age (Group C)...
Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the Republic of Korea. [2011.02.11]
This randomized trial enrolled 442 infants in the Republic of Korea to assess the immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV; Tetraxim) for primary vaccination at 2, 4 and 6 months of age compared with DTaP and IPV vaccines given separately.
Safety and immunogenicity of three different formulations of a liquid hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 4, 6 and 12-14 months of age. [2011.02.01]
The current recommended infant vaccination schedules require many injections at multiple sites, which increase stress for infants and parents and may create challenges to vaccination compliance. Therefore, combination vaccines, which reduce the number of injections at each medical visit, can be an essential method to improve compliance...
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 Infanrixâ¢-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.
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar⢠and Rotarix⢠in Healthy Latin American Infants [Recruiting]
The purpose of this study is to generate immunogenicity and safety data of an
investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine,
Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines.
Primary Objectives:
- To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T
vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with
Prevenar™ and Rotarix™, in terms of immunoresponses.
- To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to
the licensed hexavalent Infanrix hexa vaccine when given with Prevenar⢠and Rotarixâ¢.
Secondary Objectives:
- To describe in each group the immunogenicity parameters for all antigens for each
vaccine
- To assess the safety profile in terms of solicited and unsolicited adverse events and
serious adverse events in each group for each vaccine.
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.
|
