Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older
Public ClinicalTrials.gov record NCT06118151. 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 I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adults 18 Years of Age and Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include: Study Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control. Visit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181
Study identification
- NCT ID
- NCT06118151
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 388 participants
Conditions and interventions
Conditions
Interventions
- Influenza Hemagglutinin mRNA vaccine Biological
- Quadrivalent Recombinant Influenza Vaccine 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
- Apr 11, 2022 (Actual)
- Primary completion
- Feb 17, 2023 (Actual)
- Completion
- Feb 17, 2023 (Actual)
- Last update posted
- Nov 7, 2023
2022 – 2023
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Peninsula Research Associates Site Number : 8400013 | Rolling Hills Estates | California | 90274 | — |
| Optimal Research Site Number : 8400026 | San Diego | California | 92108 | — |
| AMR Coral Gables/Miami, Formerly Clinical Research of South Florida, an AMR company (Clinic) Site Number : 8400004 | Coral Gables | Florida | 33134 | — |
| Research Centers of America Site Number : 8400003 | Hollywood | Florida | 33024 | — |
| Meridian Clinical Research, LLC Site Number : 8400016 | Savannah | Georgia | 31406 | — |
| AES Peoria Site Number : 8400017 | Peoria | Illinois | 61614 | — |
| AMR El Dorado Site Number : 8400009 | El Dorado | Kansas | 67042 | — |
| AMR - Newton Site Number : 8400005 | Newton | Kansas | 67114 | — |
| AMR Wichita West Site Number : 8400030 | Wichita | Kansas | 67205 | — |
| AMR Lexington Site Number : 8400014 | Lexington | Kentucky | 40509 | — |
| Benchmark Research Site Number : 8400010 | Metairie | Louisiana | 70006 | — |
| Quality Clinical Research Site Number : 8400018 | Omaha | Nebraska | 68112 | — |
| Velocity Clinical Research, Omaha Site Number : 8400007 | Omaha | Nebraska | 68134 | — |
| Velocity Clinical Research Vestal Site Number : 8400033 | Vestal | New York | 13850 | — |
| Coastal Carolina Research Center - N Charleston Site Number : 8400008 | North Charleston | South Carolina | 29405 | — |
| AMR Knoxville Site Number : 8400027 | Knoxville | Tennessee | 37920 | — |
| Elligo Health Research, Inc. Site Number : 8400035 | Austin | Texas | 78704 | — |
| Benchmark Research - Austin Site Number : 8400006 | Austin | Texas | 78705 | — |
| AES Austin Site Number : 8400021 | Austin | Texas | 78744 | — |
| Clinical Trials of Texas, Inc. Site Number : 8400012 | San Antonio | Texas | 78229 | — |
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 NCT06118151, 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 Nov 7, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06118151 live on ClinicalTrials.gov.