Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects
Public ClinicalTrials.gov record NCT04451954. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens Without or With Adjuvant in Healthy Adult Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04451954
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 210 participants
Conditions and interventions
Conditions
Interventions
- Quadrivalent RIV with H3 strain 1 Biological
- Quadrivalent RIV with H3 strain 1 and adjuvant Biological
- Quadrivalent RIV with H3 strain 2 Biological
- Quadrivalent RIV with H3 strain 2 and adjuvant Biological
- Quadrivalent RIV with 2018-2019 NH H3 strain Biological
- Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 1, 2020
- Primary completion
- Sep 19, 2021
- Completion
- Sep 19, 2021
- Last update posted
- Sep 16, 2025
2020 – 2021
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400003 | San Diego | California | 92108 | — |
| Investigational Site Number 8400002 | Melbourne | Florida | 32934 | — |
| Investigational Site Number 8400004 | Orlando | Florida | 32806 | — |
| Investigational Site Number 8400001 | Peoria | Illinois | 61614 | — |
| Investigational Site Number 8400005 | Rockville | Maryland | 20850 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04451954, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 16, 2025 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04451954 live on ClinicalTrials.gov.