NCT00345358

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Evaluate Immunogenicity, Safety & Reactogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine Given as Catch-up Immunization in Children Older Than 7 mo of Age or as 3-dose Primary Immunization in Children Before 6 mo of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 9 Weeks – 60 Months
• Healthy volunteers: Accepted

Summary

The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be evaluated for four different age groups with different schedules: \< 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib vaccine.

Detailed description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Synflorix	1, 2, 3 or 4 Intramuscular injections, depending on age group
BIOLOGICAL	Infanrix IPV/Hib	4 intramuscular injections

Timeline

• Start date: 2006-09-18
• Primary completion: 2007-11-15
• Completion: 2007-11-15
• First posted: 2006-06-28
• Last updated: 2019-01-15
• Results posted: 2019-01-15

Locations

10 sites across 1 country: Finland