drugset / Trial / NCT00290303
Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vaccine to Tritanrix™-HepB/Hiberix™ when given to healthy infants (born to mothers who do not carry hepatitis B virus) at 6, 10 \& 14 weeks of age. This study will also include a small group of infants born to mothers who do carry hepatitis B virus; these infants will receive a birth dose of hepatitis B vaccine and will be vaccinated with Tritanrix™ HepB/Hib-MenAC at 6, 10 \& 14 weeks age.
Timeline
- Start
- 2004-05
- Primary completion
- 2005-03
- Completion
- 2005-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTPw-HBV/Hib-MenAC conjugate vaccine | Vaccine | — | — |