Trials / Completed
CompletedNCT00344318
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
To Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine Compared to Prevenar™, Co-administered With DTPw-HBV/Hib & OPV or IPV Vaccines as a 3-dose Primary Immunization Course During the First 6 Months of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 806 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age. The study has 2 groups. * One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated). * The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™. All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives \& outcome measures of the primary study. The objectives \& outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).
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 | 3 Intramuscular injections. |
| BIOLOGICAL | Prevenar | 3 Intramuscular injections |
| BIOLOGICAL | Tritanrix-HepB | 3 Intramuscular injections |
| BIOLOGICAL | Hiberix | Reconstituted with Tritanrix before injection |
| BIOLOGICAL | Polio Sabin. | 3 oral doses. |
| BIOLOGICAL | Poliorix. | 3 intramuscular injections |
Timeline
- Start date
- 2006-08-07
- Primary completion
- 2007-04-27
- Completion
- 2007-10-17
- First posted
- 2006-06-26
- Last updated
- 2018-12-07
- Results posted
- 2018-12-07
Locations
7 sites across 2 countries: Philippines, Poland
Source: ClinicalTrials.gov record NCT00344318. Inclusion in this directory is not an endorsement.