Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Influenza
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A sentinel safety cohort is selected for collection safety events where QIV-HD will be administered open-label in 100 participants. These subjects will not provide blood samples and will not be followed for influenza-like illness (ILI) surveillance. A re-vaccination cohort will be composed of a subset of approximately 120 participants from Season 1 (2021-2022 Northern Hemisphere) will be re-enrolled and re-randomized in Season 3.The re-vaccination cohort will be included re-randomized to receive either QIV-HD or QIV-SD, will provide blood samples in Season 1 and Season 3, and will not be followed for ILI surveillance during their participation in Season 3.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: A total of 100 participants will be in an uncontrolled, open-label sentinel cohort, while all other participants will be in an randomized, modified double-blind design. The following measures will ensure the integrity of the blinded data for the participants in the randomized, modified double-blind cohort: The unblinded qualified study staff member, independent of the safety evaluation and other study evaluations, will administer the vaccine The Investigators (or delegates) in charge of safety assessment, the study staff who collect the safety data, and the laboratory personnel who analyze the blood samples will not know which product was administered The participant / parent / guardian will not know which product was administered. To maintain the blinding of the participant / parent / guardian, the vaccine syringe label will be covered with appropriate materials prior to administration. Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 635 years
- Gender
- Both males and females
Description
The study is planned to start in the second half of 2020 with the Sentinel Safety Cohort. Following the Sentinel Safety Cohort, the main efficacy cohort will be conducted during the 2021-2022 Northern Hemisphere influenza season (Season 1), the 2021-2022 Southern Hemisphere influenza season (Season ...
The study is planned to start in the second half of 2020 with the Sentinel Safety Cohort. Following the Sentinel Safety Cohort, the main efficacy cohort will be conducted during the 2021-2022 Northern Hemisphere influenza season (Season 1), the 2021-2022 Southern Hemisphere influenza season (Season 2), and the 2021-2022-2023 Northern Hemisphere influenza season (Season 3). Participants will receive either 1 or 2 doses of the study vaccine depending on whether they were previously influenza vaccinated or previously influenza unvaccinated, respectively. Study duration per participant is approximately 6 to 7 months.
Tracking Information
- NCT #
- NCT04544267
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
Get Well Soon