Trials / Completed
CompletedNCT00533507
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 230 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 8 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 Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Synflorix | Intramuscular injection, 3 doses. |
| BIOLOGICAL | Infanrix hexa | Intramuscular injection, 3 doses. |
| BIOLOGICAL | Rotarix | Oral, 2 doses. |
Timeline
- Start date
- 2007-09-18
- Primary completion
- 2008-06-01
- Completion
- 2008-06-06
- First posted
- 2007-09-21
- Last updated
- 2018-06-08
- Results posted
- 2009-07-24
Locations
3 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT00533507. Inclusion in this directory is not an endorsement.