Trials / Completed
CompletedNCT01248884
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) in Primary Infant Vaccination
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 721 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 60 Days – 90 Days
- Healthy volunteers
- Accepted
Summary
This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.
Detailed description
This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the exclusion criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Infanrix hexa™ | 3 doses, intramuscular into left thigh |
| BIOLOGICAL | Prevenar 13® | 3 co-administered doses, intramuscular into right thigh |
| BIOLOGICAL | GSK217744 | 3 doses, intramuscular into left thigh |
Timeline
- Start date
- 2010-12-09
- Primary completion
- 2012-01-05
- Completion
- 2012-01-05
- First posted
- 2010-11-25
- Last updated
- 2018-08-20
- Results posted
- 2014-06-06
Locations
16 sites across 2 countries: Dominican Republic, Finland
Source: ClinicalTrials.gov record NCT01248884. Inclusion in this directory is not an endorsement.