NCT01119625

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Months – 21 Months
• Healthy volunteers: Accepted

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.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal vaccine GSK1024850A	Intramuscular injection, one dose
BIOLOGICAL	Infanrix-IPV/Hib	Intramuscular injection, one dose

Timeline

• Start date: 2010-07-12
• Primary completion: 2011-02-17
• Completion: 2011-02-17
• First posted: 2010-05-07
• Last updated: 2018-09-20
• Results posted: 2012-03-22

Locations

3 sites across 1 country: Singapore