Trials / Completed
CompletedNCT01453998
Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 657 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Months – 15 Months
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Infanrix hexa | Single dose, licensed formulation, intramuscular into right thigh |
| BIOLOGICAL | Prevenar 13 | Single co-administered dose, intramuscular into left thigh |
| BIOLOGICAL | GSK217744 | Single dose, investigational formulation A or B, intramuscular into right thigh |
Timeline
- Start date
- 2011-10-14
- Primary completion
- 2012-11-12
- Completion
- 2012-11-12
- First posted
- 2011-10-18
- Last updated
- 2020-07-17
- Results posted
- 2014-07-28
Locations
16 sites across 2 countries: Dominican Republic, Finland
Source: ClinicalTrials.gov record NCT01453998. Inclusion in this directory is not an endorsement.