drugset / Trial / NCT00136604
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
RandomizedParallel-groupSingle-blindPrevention
Summary
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
Timeline
- Start
- 2006-01-22
- Primary completion
- 2006-04-23
- Completion
- 2006-04-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN | Vaccine | — | Intramuscular |
| Subject | Mencevax™ ACWY | Vaccine | — | Subcutaneous |
| Subject | Meningitec | Vaccine | — | Intramuscular |
| Subject | Tritanrix-HepB/Hib-MenAC | Vaccine | — | Intramuscular |