Trials / Completed
CompletedNCT00291343
Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 296 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 15 Months – 24 Months
- Healthy volunteers
- Accepted
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.
Detailed description
Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC. Blood samples will be drawn from subjects as follows: * prior to and one month after the full dose of the Mencevax™ ACWY vaccine. * prior to and one month after 1/5th of a dose of Mencevax™ ACWY vaccine (only for the first 75 subjects in each of the two centers).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tritanrix™- HepB | One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months |
| BIOLOGICAL | Hiberix™ | One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months |
| BIOLOGICAL | Mencevax™ ACWY | One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2007-03-15
- Completion
- 2007-03-15
- First posted
- 2006-02-14
- Last updated
- 2018-06-06
- Results posted
- 2017-08-03
Locations
2 sites across 1 country: Philippines
Source: ClinicalTrials.gov record NCT00291343. Inclusion in this directory is not an endorsement.