drugset / Trial / NCT06385821
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination".
Timeline
- Start
- 2022-09-21
- Primary completion
- 2023-06-15
- Completion
- 2023-10-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Grippol Plus | Vaccine | 0.25 ml | Intramuscular |
| Comparator | Grippol Plus | Vaccine | 0.5 ml | Intramuscular |
| Subject | Grippol Quadrivalent | Vaccine | 0.25 ml | Intramuscular |
| Subject | Grippol Quadrivalent | Vaccine | 0.5 ml | Intramuscular |