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Reactogenicity and Immunogenicity of Synflorix Co-administered with Infanrix Hexa in Infants
NCT00338351Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2006
- Countries
- 1
- Sponsor
- GSK
- Modality
- Split/Subunit Vaccines
- Conditions
- pneumococcal disease
01
Overview
Phase 2, randomised trial of 10-valent pneumococcal conjugate vaccine in pneumococcal disease (2 arms), sponsored by GSK. Primary endpoint: Grade 3 Adverse Events. Started Apr 2006; status: completed.
02
Design
2 arms- Study design
- Randomized
Synflorix Group
Synflorix + Infanrix Hexa administered at 2, 4, and 6 months
Control Group
Havrix + Infanrix Hexa administered at 2, 4, and 6 months
03
Who it enrols
Healthy male or female infants between 6 and 12 weeks of age at the time of the first vaccination.
04
Endpoints
Primary
Grade 3 Adverse Events
Secondary
Solicited and Unsolicited Adverse Events
Serious Adverse Events
Antibody Concentrations to Vaccine Antigens
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