NCT00307541

Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Phase IIIa Randomized, Controlled Study to Assess the Immunogenicity of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered as a 3-dose Primary Immunization Course Before 6 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Weeks – 16 Weeks
• Healthy volunteers: Accepted

Summary

Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age

Detailed description

Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib

Conditions

• Infections, Streptococcal
• Streptococcus Pneumoniae Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal (vaccine)

Timeline

• Start date: 2005-10-27
• Primary completion: 2006-04-07
• Completion: 2006-04-07
• First posted: 2006-03-28
• Last updated: 2020-01-02

Locations

32 sites across 1 country: Germany