drugset / Trial / NCT06947499
A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD 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
Timeline
- Start
- 2025-05-30
- Primary completion
- 2026-11
- Completion
- 2027-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Inactivated Polio Vaccine | Vaccine | — | Intramuscular |
| Subject | LBVD | Vaccine | — | Intramuscular |
| Comparator | Pentavalent vaccine | Vaccine | — | Intramuscular |