drugset / Trial / NCT05513391
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.
Timeline
- Start
- 2022-11-10
- Primary completion
- 2023-10-03
- Completion
- 2023-10-03
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Quadrivalent influenza vaccine | Vaccine | — | Intramuscular |
| Subject | Recombinant Influenza Vaccine | Vaccine | — | Intramuscular |
Indications
No indication recorded.