Trials / Completed
CompletedNCT00907777
Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™
Vaccination With the Pneumococcal Vaccine GSK 1024850A or Prevenar™ at Approximately 4 Years of Age in Children Primed With 3 Doses of GSK 1024850A Vaccine or Prevenar™ and Boosted With 23-valent Pneumococcal Plain Polysaccharide Vaccine
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 46 Months – 50 Months
- Healthy volunteers
- Accepted
Summary
The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age. Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™. This protocol posting deals with objectives \& outcome measures of the extension phase at year 4. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pneumococcal conjugate vaccine GSK 1024850A | One dose of vaccine will be injected intramuscularly into the deltoid. |
| BIOLOGICAL | Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's) | One dose of vaccine will be injected intramuscularly into the deltoid. |
Timeline
- Start date
- 2009-06-23
- Primary completion
- 2009-10-05
- Completion
- 2009-10-05
- First posted
- 2009-05-25
- Last updated
- 2020-11-23
- Results posted
- 2017-01-06
Locations
17 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00907777. Inclusion in this directory is not an endorsement.