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Clinical Trial Summary

The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be evaluated for four different age groups with different schedules:

< 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib vaccine.


Clinical Trial Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00345358
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date September 18, 2006
Completion date November 15, 2007

See also
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