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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00317122 |
This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) & hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.
Condition | Intervention | Phase |
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Diphtheria Tetanus Pertussis Hepatitis B Hib Disease Neisseria Meningitidis Serogroup Diseases |
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Demonstrate Non-Inferiority of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ With Respect to Anti-HBs Immune Response, When Given to Healthy Infants at 6,10 & 14 Wks Age, After a Birth Dose of Hepatitis B Vaccine |
Estimated Enrollment: | 192 |
Study Start Date: | October 2004 |
Randomized study with two groups to receive one of the following vaccination regimens:
Ages Eligible for Study: | up to 10 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
South Africa | |
GSK Investigational Site | |
Brits, South Africa | |
GSK Investigational Site | |
Ga-Rankuwa, South Africa, 0208 | |
GSK Investigational Site | |
Centurion, South Africa |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 759346/007 |
Study First Received: | February 23, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00317122 |
Health Authority: | South Africa: Medicines Control Council |
Bacterial Infections Liver Diseases Hepatitis, Viral, Human Whooping Cough Cough Neisseria meningitidis Healthy 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 DNA Virus Infections |
Bordetella Infections Corynebacterium Infections Infection Hepadnaviridae Infections Actinomycetales Infections |