A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
Public ClinicalTrials.gov record NCT05071313. 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 Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
Study identification
- NCT ID
- NCT05071313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 777 participants
Conditions and interventions
Interventions
- Ad26.RSV.preF-based vaccine Biological
- Quadrivalent High-dose Influenza Vaccine Biological
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2021 (Actual)
- Primary completion
- Apr 20, 2022 (Actual)
- Completion
- Oct 11, 2022 (Actual)
- Last update posted
- May 25, 2025
2021 – 2022
United States locations
- U.S. sites
- 19
- U.S. states
- 10
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ark Clinical Research | Long Beach | California | 90806 | — |
| Research Centers of America, LLC | Hollywood | Florida | 33024 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Synexus Clinical Research US Inc | The Villages | Florida | 32162 | — |
| Synexus Clinical Research US Inc | Chicago | Illinois | 60602 | — |
| Meridian Clinical Research, LLC | Rockville | Maryland | 20854 | — |
| Sundance Clinical Research | St Louis | Missouri | 63141 | — |
| Synexus Clinical Research US Inc | St Louis | Missouri | 63141 | — |
| Meridian Clinical Research, LLC | Grand Island | Nebraska | 68803 | — |
| Meridian Clinical Research, LLC | Lincoln | Nebraska | 68510 | — |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | — |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| Tekton Research Inc. | Yukon | Oklahoma | 73099 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
| VitaLink Research Spartanburg | Spartanburg | South Carolina | 29303 | — |
| AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company | Knoxville | Tennessee | 37920 | — |
| Optimal Research | Austin | Texas | 78705 | — |
| Tekton Research Inc. | Austin | Texas | 78745 | — |
| DM Clinical Research | Tomball | Texas | 77375 | — |
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 NCT05071313, 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 May 25, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05071313 live on ClinicalTrials.gov.