NCT00307034

Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule

An Open, Randomized, Phase IIIa Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly According to a 2-4-11 Months Vaccination Schedule

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Weeks – 16 Weeks
• Healthy volunteers: Accepted

Summary

Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)

Detailed description

Total anticipated: 300 subjects (150/group). 2-dose group - 10-valent pneumococcal vaccine + DTPa combined vaccine (2, 4, 11 months); Comparator group - 10-valent pneumococcal vaccine (2, 3, 4, 11 months) + DTPa combined vaccine (2, 4, 11 months). 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	GSK Biologicals' 10-valent pneumococcal conjugate vaccine.	Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).
BIOLOGICAL	Infanrix hexa.	Intramuscular injection, 3 doses (2-4-11 months of age schedule).
BIOLOGICAL	Infanrix-IPV/Hib.	Intramuscular injection, 3 doses (2-4-11 months of age schedule).

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-01-01
• Completion: 2007-01-25
• First posted: 2006-03-27
• Last updated: 2018-06-08
• Results posted: 2017-04-04

Locations

8 sites across 4 countries: Denmark, Norway, Slovakia, Sweden