At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa
In Brief
A Phase 3 clinical trial evaluating Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine, and 1 other intervention for Meningococcal Immunization and Healthy Volunteers. Completed, enrolled 1,328 participants across 17 sites in 2 countries.
Detailed Summary
This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in RSA.
Study Details
Timeline
Interventions
Pharmaceutical form: solution for injection; Route of administration: intramuscular, 0.5 mL
Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL
Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL