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NCT04544267 · ClinicalTrials.gov registry record · Phase 3
Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT04544267 is a Phase 3 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 100 participants.
The verdict
NCT04544267, a Phase 3 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
The primary objective of the study was to compare the clinical efficacy of high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose quadrivalent influenza vaccine (QIV-SD) in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type. The secondary objectives of the study were: * 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 any influenza 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 the vaccine. * in participants 6 months through 23 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza 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
Interventions
- BIOLOGICAL Quadrivalent influenza vaccine, high-dose
- BIOLOGICAL Quadrivalent influenza vaccine, standard dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2021-06-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04544267
The ClinicalTrials.gov registry entry for NCT04544267 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Quadrivalent influenza vaccine, high-dose is the first listed.
NCT04544267 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04544267 about?
NCT04544267 is a clinical study titled "Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age". The primary objective of the study was to compare the clinical efficacy of high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose quadrivalent influenza vaccine (QIV-SD) in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused ...
What is the current status of trial NCT04544267?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2020-09-15. Estimated completion is 2021-06-02.
What interventions are being tested in trial NCT04544267?
The interventions under investigation include: Quadrivalent influenza vaccine, high-dose (BIOLOGICAL), Quadrivalent influenza vaccine, standard dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT04544267?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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