Trial intelligence / Profile preview

Safety and Immunogenicity of MenACYW Conjugate Vaccine in Infants and Toddlers

NCT01049035Phase 2Completed

Sponsor
Sanofi
Start
Dec 2009
Primary completion
Feb 2012
Modality
Vaccines & Immunotherapeutics
Countries
1
01

Overview

Phase 2, randomised, open-label trial of meningococcal A conjugate vaccine in meningococcal infection (7 arms), sponsored by Sanofi. Primary endpoints: Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4 at 16 months, Percentage of Participants With SBA-HC Pre-booster/Pre-vaccination Titer >= 1:8 or < 1:8 Who Then Achieved >= 4-Fold Rise in SBA-HC Titer After Vaccination at 16 months and 15 more. Started Dec 2009; status: completed.

02

Drugs

meningococcal A conjugate vaccine
03

Conditions

meningococcal infection

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