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NCT04144179 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens in Healthy Adult Subjects 18 to 30 Years of Age
A Phase 1 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 3
- Study locations
NCT04144179: Completed Phase 1 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04144179 is a Phase 1 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 150 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04144179, a Phase 1 study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary objectives of the study are: * To describe the safety profile of the different quadrivalent recombinant influenza vaccine (RIV) formulations. * To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives of the study 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 HAI and SN antibody responses in each group against each of the H3 antigens. * To compare the HAI and SN antibody responses for the groups with different H3 antigens to the control group.
Primary Outcome
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Conditions Studied
Interventions
- BIOLOGICAL Quadrivalent RIV with H3 strain 1
- BIOLOGICAL Quadrivalent RIV with H3 strain 2
- BIOLOGICAL Quadrivalent RIV with H3 strain 3
- BIOLOGICAL Quadrivalent RIV with H3 strain 4
- BIOLOGICAL Quadrivalent RIV with 2018-2019 NH H3 strain
Study Locations (3)
Florida
- Research Centers of America Site Number : 8400002 - Hollywood
New York
- Rochester Clinical Research, Inc. Site Number : 8400001 - Rochester
South Carolina
- Coastal Carolina Research Center Site Number : 8400003 - North Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-11-06 |
| Est. Completion | 2020-02-24 |
| Phase | Phase 1 |
What the finished NCT04144179 record still lists
NCT04144179 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 5 interventions - of which Quadrivalent RIV with H3 strain 1 is the first listed.
NCT04144179 reports a single indexed study location in Florida, New York, South Carolina.
Frequently Asked Questions
What is clinical trial NCT04144179 about?
NCT04144179 is a clinical study titled "Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens in Healthy Adult Subjects 18 to 30 Years of Age". The primary objectives of the study are: * To describe the safety profile of the different quadrivalent recombinant influenza vaccine (RIV) formulations. * To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (HA) (H1, H3, B/Victoria...
What is the current status of trial NCT04144179?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2019-11-06. Estimated completion is 2020-02-24.
What conditions does trial NCT04144179 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT04144179?
The interventions under investigation include: Quadrivalent RIV with H3 strain 1 (BIOLOGICAL), Quadrivalent RIV with H3 strain 2 (BIOLOGICAL), Quadrivalent RIV with H3 strain 3 (BIOLOGICAL), Quadrivalent RIV with H3 strain 4 (BIOLOGICAL), Quadrivalent RIV with 2018-2019 NH H3 strain (BIOLOGICAL).
Who is sponsoring clinical trial NCT04144179?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04144179 being conducted?
This trial has 3 study locations across Florida, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04144179's enrollment target sits among peer trials
150 90th of 156 higher than 64 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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.
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