Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
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- STATUS
- Recruiting
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- participants needed
- 13320
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- sponsor
- Sanofi Pasteur, a Sanofi Company
Summary
The primary objective of the study is to compare the clinical efficacy of high-dose
quadrivalent
The secondary objectives of the study are:
- To compare QIV-HD to QIV-SD:
- in participants 6 months through 35 months of age for the prevention of
laboratory-confirmed
influenza illness caused by anyinfluenza A or B type using a more stringent threshold - in participants 6 months through 35 months of age for the prevention of
laboratory-confirmed protocol-defined
influenza-like illness caused by viral strains similar to those contained in thevaccine . - in participants 6 months through 23 months of age for the prevention of
laboratory-confirmed
influenza illness caused by anyinfluenza A or B types. - To compare
hemagglutination inhibition (HAI) immune response of QIV-HD to QIV-SD in participants 6 months through 35 months of age - To describe the HAI, seroneutralization (SN), and anti-neuraminidase (NA) immune response
- To describe the immune response to revaccination in Season 3 (Northern Hemisphere)
- To describe the safety profile of each
vaccine
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
Participants will receive either 1 or 2 doses of the study
Study duration per participant is approximately 6 to 7 months.
Details
Condition |
|
---|---|
Age | 1years - 1years |
Treatment |
Quadrivalent |
Clinical Study Identifier | NCT04544267 |
Sponsor | Sanofi Pasteur, a Sanofi Company |
Last Modified on | 19 February 2024 |
How to participate?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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