drugset / Trial / NCT04143061
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
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2019-12-30
- Primary completion
- 2023-01-28
- Completion
- 2023-01-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine | Vaccine | 0.5 ml | Intramuscular |
| Subject | Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine | Vaccine | 0.5 ml | Intramuscular |