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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00317174 |
The purpose of the study is as follows:
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Pertussis Hepatitis B Hib Disease Neisseria Meningitidis Serogroup Diseases |
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Assess Immune Persistence & Memory by Giving Plain PRP,PSA & PSC (10 Mths Age), & Immunogenicity & Safety of a Tritanrix™-HBV/Hib-MenAC/ Tritanrix™-HBV/Hib2.5 Booster (15-18 Mths Age) in Previously Primed Subjects |
Estimated Enrollment: | 450 |
Study Start Date: | July 2003 |
This study will be conducted in two stages:
At 10 months age, half of the subjects will receive a dose of plain meningococcal AC and PRP polysaccharide (PS) vaccine at 10 months age.
At 15 to 18 months age (DTP booster phase), all subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hib2.5.
Ages Eligible for Study: | 10 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 759346/002 |
Study First Received: | February 15, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00317174 History of Changes |
Health Authority: | Philippines: Bureau of Food and Drugs |
Bacterial Infections Liver Diseases Hepatitis, Viral, Human Whooping Cough Cough Neisseria Meningitidis Diphtheria Tetanus Gram-Negative Bacterial Infections Virus Diseases |
Hepatitis Antibodies Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Hepatitis B DNA Virus Infections Immunoglobulins |
Bacterial Infections Liver Diseases Hepatitis, Viral, Human Whooping Cough Diphtheria Infection Hepadnaviridae Infections Actinomycetales Infections Gram-Negative Bacterial Infections Virus Diseases |
Hepatitis Bordetella Infections Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Corynebacterium Infections Hepatitis B DNA Virus Infections |