drugset / Trial / NCT05779020
Immunogenicity and Safety of Butantan Quadrivalent Influenza Vaccine (Split Virion, Inactivated) in Infants and Children .
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a Phase III Randomized Clinical Trial, blind, multicenter, with active controls, to evaluate the immunogenicity and safety of the Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan, in two dose scheme (0.25ml and 0.50ml), in infants and children under 3 years of age.
Timeline
- Start
- 2023-04-25
- Primary completion
- 2024-09-12
- Completion
- 2025-08-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Quadrivalent influenza vaccine(Split Virion),Inactivated | Vaccine | 0.25 ml | — |
| Subject | Quadrivalent influenza vaccine(Split Virion),Inactivated | Vaccine | 0.5 ml | — |
| Comparator | Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage | Vaccine | 0.5 ml | — |
| Comparator | Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage | Vaccine | 0.25 ml | — |