Trials / Completed
CompletedNCT00463437
Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines
Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,437 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 11 Months – 18 Months
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine. 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 = NCT00334334).
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 | Pneumococcal conjugate vaccine GSK1024850A | Intramuscular injection, 1 dose. |
| BIOLOGICAL | Prevenar | Intramuscular injection, 1 dose. |
| BIOLOGICAL | Infanrix hexa | Intramuscular injection, 1 dose. In Germany and Poland. |
| BIOLOGICAL | Infanrix IPV Hib | Intramuscular injection, 1 dose. In Spain. |
| BIOLOGICAL | Infanrix penta | Intramuscular injection, 1 dose. In Germany and Poland. |
| BIOLOGICAL | Infanrix IPV | Intramuscular injection, 1 dose. In Spain. |
| BIOLOGICAL | Meningitec | Intramuscular injection, 1 dose. |
| BIOLOGICAL | NeisVac-C | Intramuscular injection, 1 dose. |
| BIOLOGICAL | Menitorix | Intramuscular injection, 1 dose. |
Timeline
- Start date
- 2007-04-25
- Primary completion
- 2008-01-21
- Completion
- 2008-06-14
- First posted
- 2007-04-20
- Last updated
- 2020-01-02
- Results posted
- 2009-08-03
Locations
63 sites across 3 countries: Germany, Poland, Spain
Source: ClinicalTrials.gov record NCT00463437. Inclusion in this directory is not an endorsement.