Trials / Completed
CompletedNCT00489554
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks 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 – 12 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 Mexican infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine (Infanrix hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months of age.
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
- 2007-07-03
- Primary completion
- 2008-03-31
- Completion
- 2008-03-31
- First posted
- 2007-06-21
- Last updated
- 2020-01-13
- Results posted
- 2012-05-10
Locations
2 sites across 1 country: Mexico
Source: ClinicalTrials.gov record NCT00489554. Inclusion in this directory is not an endorsement.