Trials / Completed
CompletedNCT00611559
Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
Immunogenicity and Reactogenicity Study of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 283 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Months – 23 Months
- Healthy volunteers
- Accepted
Summary
The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study. The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Infanrix™ penta | Subjects received a booster dose |
| BIOLOGICAL | Infanrix™ hexa | Subjects received a booster dose |
Timeline
- Start date
- 2008-02-14
- Primary completion
- 2008-06-25
- Completion
- 2008-06-25
- First posted
- 2008-02-11
- Last updated
- 2018-06-06
- Results posted
- 2009-08-10
Locations
3 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT00611559. Inclusion in this directory is not an endorsement.