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NCT04451954 · ClinicalTrials.gov registry record · Phase 1
Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 210
- Enrollment target
NCT04451954 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 210 participants.
The verdict
NCT04451954, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 210 participants
- Enrollment target
Study Summary
The primary objectives of the study are: * To describe the safety profile of the different formulations in all participants * To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives are: * To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations). * To describe SN antibody responses in each group against each of the H3 antigens. * To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group. * To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.
Interventions
- BIOLOGICAL Quadrivalent RIV with H3 strain 1
- BIOLOGICAL Quadrivalent RIV with H3 strain 2
- BIOLOGICAL Quadrivalent RIV with 2018-2019 NH H3 strain
- BIOLOGICAL Quadrivalent RIV with H3 strain 1 and adjuvant
- BIOLOGICAL Quadrivalent RIV with H3 strain 2 and adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2020-07-02 |
| Est. Completion | 2021-09-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04451954
The ClinicalTrials.gov registry entry for NCT04451954 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 210 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 5 interventions - of which Quadrivalent RIV with H3 strain 1 is the first listed.
NCT04451954 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04451954 about?
NCT04451954 is a clinical study titled "Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects". The primary objectives of the study are: * To describe the safety profile of the different formulations in all participants * To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in ...
What is the current status of trial NCT04451954?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 210 participants. The study started on 2020-07-02. Estimated completion is 2021-09-20.
What interventions are being tested in trial NCT04451954?
The interventions under investigation include: Quadrivalent RIV with H3 strain 1 (BIOLOGICAL), Quadrivalent RIV with H3 strain 2 (BIOLOGICAL), Quadrivalent RIV with 2018-2019 NH H3 strain (BIOLOGICAL), Quadrivalent RIV with H3 strain 1 and adjuvant (BIOLOGICAL), Quadrivalent RIV with H3 strain 2 and adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT04451954?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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