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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00291343 |
This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. In the Mencevax™ ACWY "small dose" stage at 30 to 36 months of age, the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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Diphtheria Tetanus Pertussis Hepatitis B Hib Disease Neisseria Meningitidis Serogroup Diseases |
Biological: Tritanrix™- HepB Biological: Hiberix™ Biological: Mencevax™ ACWY |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study |
Enrollment: | 296 |
Study Start Date: | February 2006 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group B: Active Comparator
AC unprimed group
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Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Mencevax™ ACWY
One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
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Group A: Experimental
AC primed group
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Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Mencevax™ ACWY
One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
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Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC.
Blood samples will be drawn from subjects as follows:
Ages Eligible for Study: | 15 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Philippines | |
GSK Investigational Site | |
Manila, Philippines, 1000 | |
GSK Investigational Site | |
Manila, Philippines |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 105239 (mth24-30), 105245 (mth30-36) |
Study First Received: | February 13, 2006 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00291343 |
Health Authority: | Philippines: Bureau of Food and Drugs |
Prophylaxis diphtheria tetanus pertussis hepatitis B |
Haemophilus influenzae type b meningococcal serogroups A and C diseases meningococcal vaccine |
Bacterial Infections Liver Diseases Haemophilus influenzae Hepatitis, Viral, Human Whooping Cough Cough Neisseria meningitidis Diphtheria Tetanus Whooping cough Gram-Negative Bacterial Infections |
Virus Diseases Hepatitis Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Hepatitis B Influenza, Human DNA Virus Infections Clostridium Infections |
Bordetella Infections Corynebacterium Infections Infection Hepadnaviridae Infections Actinomycetales Infections |