Trials / Completed
CompletedNCT00678301
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 365 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 10 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.
Detailed description
Vaccination course at 6, 10, 14 weeks of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK Biologicals' Synflorix™ | 3 IM doses. |
| BIOLOGICAL | GSK Biologicals' Polio Sabin™ | 3 oral doses |
| BIOLOGICAL | GSK Biologicals' Zilbrix™ Hib | 3 IM doses. |
Timeline
- Start date
- 2008-06-18
- Primary completion
- 2009-11-09
- Completion
- 2009-12-10
- First posted
- 2008-05-15
- Last updated
- 2019-11-15
- Results posted
- 2017-10-27
Locations
2 sites across 2 countries: Mali, Nigeria
Source: ClinicalTrials.gov record NCT00678301. Inclusion in this directory is not an endorsement.