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 (MET55)

NCT04143061 PHASE3 COMPLETED Results posted

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.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	PHASE3
Status	COMPLETED
Enrolment	1328
Start date	Mon Dec 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sat Jan 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Meningococcal Immunization
• Healthy Volunteers

Interventions

• 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
• Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine

Countries

South Africa, India