drugset / Trial / NCT00291343
Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
RandomizedParallel-groupOpen-labelPrevention
Summary
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.
Timeline
- Start
- 2006-02-01
- Primary completion
- 2007-03-15
- Completion
- 2007-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mencevax™ ACWY | Vaccine | 0.2 unknown | Subcutaneous |
| Background | HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN | Vaccine | — | Intramuscular |
| Background | Tritanrix-HepB | Vaccine | — | Intramuscular |