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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: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04451954 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 210 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (250% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
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 |
What the finished NCT04451954 record still lists
NCT04451954 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (250% higher).
The record links to 0 conditions, and to 5 interventions - of which Quadrivalent RIV with H3 strain 1 is the first listed.
NCT04451954 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04451954's enrollment target sits among peer trials
210 245th of 2000 higher than 1,751 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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