At a glance
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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.
In Brief
A Phase 3 clinical trial evaluating Pneumococcal vaccine GSK1024850A, Tritanrix-HepB/Hib, and 3 other interventions for Infections, Streptococcal. Completed, enrolled 489 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 4 doses
Intramuscular injection, 2 doses
Oral, 2 doses
Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine