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Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose

Infections, Streptococcal Clinical Trial

Official title:
Evaluation of Immunological Persistence Following 3-dose Priming With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine in Study NCT00808444 and Safety and Immunogenicity Following a Booster Dose of the Same Vaccine

Clinical Trial Summary

This primary purpose of this study is the evaluation of the immunological persistence following completion of the 3-dose primary vaccination course with either a clinical or a commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In addition, the study will also assess the safety, reactogenicity and immunogenicity of a fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study NCT00808444.

The primary vaccination study was conducted in Malaysia and Singapore. The booster vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally recommended regimen. Administration of the booster dose will be outside the set-up of a clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01119625
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date July 12, 2010
Completion date February 17, 2011
View Details
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