Trials / Completed
CompletedNCT00370396
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
To Assess the Safety, Reactogenicity & Immunogenicity of a 4th Dose of GSK Biologicals' Pneumococcal Vaccine or Prevenar™ in Children (12-18 Months) Previously Vaccinated in the Primary Study NCT00307554 With Either Pneumococcal Vaccine or Prevenar™
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,200 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Months – 18 Months
- Healthy volunteers
- Accepted
Summary
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™. The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Synflorix | 1 dose injected IM in the right thigh or deltoid. |
| BIOLOGICAL | Prevenar | 1 dose injected IM in the right thigh or deltoid. |
| BIOLOGICAL | Infanrix hexa | 1 dose injected IM in the right thigh or deltoid. |
Timeline
- Start date
- 2006-09-25
- Primary completion
- 2007-06-04
- Completion
- 2007-11-06
- First posted
- 2006-08-31
- Last updated
- 2019-06-10
- Results posted
- 2018-11-26
Locations
35 sites across 3 countries: Finland, France, Poland
Source: ClinicalTrials.gov record NCT00370396. Inclusion in this directory is not an endorsement.