NCT00829010

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.

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 489 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 10 Weeks
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal vaccine GSK1024850A	Intramuscular injection, administered as 3 or 4 doses
BIOLOGICAL	Tritanrix-HepB/Hib	Intramuscular injection, 4 doses
BIOLOGICAL	measles	Intramuscular injection, 2 doses
BIOLOGICAL	Rotarix	Oral, 2 doses
BIOLOGICAL	Local OPV	Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine

Timeline

• Start date: 2009-02-17
• Primary completion: 2011-06-13
• Completion: 2012-06-27
• First posted: 2009-01-26
• Last updated: 2018-08-17
• Results posted: 2012-07-06

Locations

1 site across 1 country: South Africa