Study to Evaluate the Safety and the Immunogenicity of a Second Generation Structurally Designed mRNA Vaccine Candidate Against Pandemic Influenza H5 HA Strain in Healthy Adult Participants Aged 18 Years and Older
Public ClinicalTrials.gov record NCT06907511. 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
A Phase 1/2, Parallel-group, Randomized, Modified Double-blind, Placebo-controlled, Multi-center, Dose Ranging Study to Evaluate the Safety and Immunogenicity of a Second Generation Structurally Designed Pandemic Influenza H5 HA mRNA Vaccine in Healthy Adults Aged 18 Years and Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this phase 1/2 study is to investigate the safety and immunogenicity of different doses (high, medium and low) of a second generation structurally designed (SD2) H5 messenger ribonucleic acid (mRNA) vaccine against pandemic H5 influenza virus (pandemic flu H5 hemagglutinin (HA) mRNA SD2) in healthy younger and older adults. The study will aim to identify the appropriate dose for further clinical development of a potential pandemic response vaccine. The study also includes an extension phase for one of the 3 dose levels of the pandemic flu H5 HA mRNA SD2 vaccine to collect additional safety and the immunogenicity data for this specific dose of the vaccine. During this Extension Phase, an additional 480 participants will be randomized according to a 1:1 ratio and stratified by age (≥ 18 to \< 65 years and ≥ 65 years) to receive either the low dose of the pandemic flu H5 HA mRNA DS2 vaccine (Group 1) or placebo (Group 4). This extension will enhance the safety database and improve precision of the immunogenicity results for the selected dose while preserving the original study design integrity. The study duration per participant will be approximately 13 months. There will be two injections of placebo or pandemic flu H5 mRNA vaccine 21 days apart at high, medium and low doses. Study visits/contact include: 7 study visits and 1 telephone call. Vaccination visits (including blood samples) will occur at Day 01 and Day 22. Short-term follow-up visits (including blood samples) will occur 8 and 21 days after each injection. Participants will be also followed up (including blood samples) at 3 and 6 months after 2nd injection, and at 12 months after 2nd injection for safety.
Study identification
- NCT ID
- NCT06907511
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 720 participants
Conditions and interventions
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
- Apr 16, 2025
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Jan 15, 2026
2025 – 2026
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Velocity Clinical Research - San Diego- Site Number : 8400013 | La Mesa | California | 91942 | — |
| Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400002 | DeLand | Florida | 32720 | — |
| Accel Research Sites - Lakeland Clinical Research Unit- Site Number : 8400006 | Lakeland | Florida | 33803 | — |
| Accel Research Sites - St. Petersburg - Largo- Site Number : 8400004 | Largo | Florida | 33777 | — |
| Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400003 | Decatur | Georgia | 30030-2627 | — |
| QUEST Research Institute- Site Number : 8400014 | Bingham Farms | Michigan | 48334 | — |
| Velocity Clinical Research - Norfolk- Site Number : 8400015 | Norfolk | Nebraska | 68701 | — |
| Velocity Clinical Research - Omaha- Site Number : 8400012 | Omaha | Nebraska | 68134 | — |
| Velocity Clinical Research - Springdale- Site Number : 8400010 | Cincinnati | Ohio | 45246 | — |
| Coastal Carolina Research Center- Site Number : 8400001 | North Charleston | South Carolina | 29406 | — |
| Olympus Clinical Research - Sugar Land- Site Number : 8400009 | Sugar Land | Texas | 77479 | — |
| Velocity Clinical Research - Salt Lake City- Site Number : 8400011 | West Jordan | Utah | 84088 | — |
| Charlottesville Medical Research- Site Number : 8400005 | Charlottesville | Virginia | 22911 | — |
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 NCT06907511, 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 Jan 15, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06907511 live on ClinicalTrials.gov.