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Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.

Infections, Streptococcal Clinical Trial

Official title:
Primary and Booster Vaccination Course in Human Immunodeficiency Virus (HIV) Infected Infants, HIV Exposed Uninfected Infants and Unexposed Uninfected Infants Receiving the Pneumococcal Vaccine GSK 1024850A.

Clinical Trial Summary

The purposes of this study:

- To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age and following booster vaccination at 9-10 months of age.

- To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age with or without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at 6 and 14 weeks of age followed by booster vaccination at 9-10 months of age.

- This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all study participants.

Clinical Trial Description

This protocol posting has been updated according to Protocol amendment 1, December 08 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00829010
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date February 17, 2009
Completion date June 27, 2012
View Details
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