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Safety and Immunogenicity of Concomitant MenC-TT and PCV7 in Toddlers
NCT00617760Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2008
- Primary completion
- Aug 2009
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- Meningococcal group C infection
01
Overview
Phase 3, randomised, open-label trial of Meningococcal group C polysaccharide conjugate vaccine in Meningococcal group C infection (3 arms), sponsored by Pfizer. Primary endpoints: Number of subjects achieving PCV7-specific antibody concentrations >= 0.2 mg/mL and Number of subjects achieving sero-protective levels of MenC-specific SBA titer >= 1:8. Started Mar 2008; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Concomitant
MenC-TT + PCV7
PCV7 Control
PCV7 only
MenC-TT Control
MenC-TT only
03
Who it enrols
Healthy toddlers aged 12-18 months who have completed the primary PCV7 series but have not received a PCV7 booster or prior MenC vaccine.
04
Endpoints
Primary
Number of subjects achieving PCV7-specific antibody concentrations >= 0.2 mg/mL
Number of subjects achieving sero-protective levels of MenC-specific SBA titer >= 1:8
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