drugset / Trial / NCT05457946
Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)
Timeline
- Start
- 2023-04-01
- Primary completion
- 2025-09-30
- Completion
- 2025-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Inactivated Polio vaccine (Sabin strains) | Vaccine | — | Intramuscular |
| Subject | LBVD | Vaccine | — | Intramuscular |
| Comparator | Pentavalent vaccine | Vaccine | — | Intramuscular |