Trials / Completed
CompletedNCT00814710
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (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 Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pneumococcal conjugate vaccine GSK1024850A | Intramuscular injection, 3 doses |
| BIOLOGICAL | Tritanrix-HepB/Hib | Intramuscular injection, 3 doses |
| BIOLOGICAL | Hiberix | Intramuscular injection, 3 doses |
| BIOLOGICAL | Tritanrix-HepB | Intramuscular injection, 3 doses |
Timeline
- Start date
- 2009-03-07
- Primary completion
- 2009-11-13
- Completion
- 2009-11-13
- First posted
- 2008-12-25
- Last updated
- 2020-01-03
- Results posted
- 2010-10-29
Locations
4 sites across 1 country: India
Source: ClinicalTrials.gov record NCT00814710. Inclusion in this directory is not an endorsement.