NCT00758264

Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration

Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-administered With GSK Biologicals' Pneumococcal Vaccine GSK1024850A in Healthy 12-23-month-old Children Previously Primed With GSK1024850A

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered individually.

Detailed description

Multi-center study with 3 parallel groups. One group will receive 2 vaccines injections at the same visit (pneumococcal+ meningococcal), one group will receive a pneumococcal vaccine followed one month later by a meningococcal vaccine, and the last group will receive the meningococcal vaccine followed one month later by the pneumococcal vaccine. All subjects will have one blood sample taken before vaccination and one blood sample taken one month after each vaccination (i.e. the first group will have 2 blood samples taken, and the other two groups will have 3 blood sample taken)

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal vaccine GSK134612	Single dose intramuscular injection.
BIOLOGICAL	Pneumococcal vaccine GSK1024850A	Single dose intramuscular injection.

Timeline

• Start date: 2008-10-30
• Primary completion: 2009-06-02
• Completion: 2009-11-02
• First posted: 2008-09-25
• Last updated: 2018-05-09
• Results posted: 2018-05-09

Locations

5 sites across 2 countries: Mexico, Taiwan