Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens in Healthy Adult Subjects 18 to 30 Years of Age
Public ClinicalTrials.gov record NCT04144179. 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.
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 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.
Study identification
- NCT ID
- NCT04144179
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Interventions
- 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
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 30 Years
- 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
- Nov 5, 2019
- Primary completion
- Feb 23, 2020
- Completion
- Feb 23, 2020
- Last update posted
- Jul 28, 2025
2019 – 2020
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Centers of America Site Number : 8400002 | Hollywood | Florida | 33024 | — |
| Rochester Clinical Research, Inc. Site Number : 8400001 | Rochester | New York | 14609 | — |
| Coastal Carolina Research Center Site Number : 8400003 | North Charleston | South Carolina | 29405 | — |
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 NCT04144179, 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 Jul 28, 2025 · Synced Sep 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04144179 live on ClinicalTrials.gov.