Trials / Completed
CompletedNCT00547248
Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
Booster Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in Children Who Completed the Primary Vaccination Course in Study 107007
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 756 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Months – 18 Months
- Healthy volunteers
- Accepted
Summary
The purpose of this observer blind study is to assess the safety in terms of fever \>39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00344318)
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, 1 dose |
| BIOLOGICAL | Tritanrix-HepB | Intramuscular injection, 1 dose |
| BIOLOGICAL | Hiberix | Reconstituted with Tritanrix-Hep B before injection |
| BIOLOGICAL | Polio Sabin | Oral, 1 dose |
| BIOLOGICAL | Poliorix | Intramuscular injection, 1 dose |
| BIOLOGICAL | Prevenar (Wyeth) | Intramuscular injection, 1 dose |
Timeline
- Start date
- 2007-10-22
- Primary completion
- 2008-05-10
- Completion
- 2008-10-07
- First posted
- 2007-10-22
- Last updated
- 2019-01-14
- Results posted
- 2019-01-14
Locations
7 sites across 2 countries: Philippines, Poland
Source: ClinicalTrials.gov record NCT00547248. Inclusion in this directory is not an endorsement.