A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
Public ClinicalTrials.gov record NCT03502707. 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 1/2a Study for Safety and Immunogenicity Evaluations for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study for: Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3. Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen. Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.
Study identification
- NCT ID
- NCT03502707
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 669 participants
Conditions and interventions
Conditions
Interventions
- Placebo Biological
- RSV preF Protein 50 mcg Biological
- RSV preF Protein 150 mcg Biological
- Ad26.RSV.preF 1*10^11 vp Biological
- Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg Biological
- Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg Biological
- Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg Biological
- Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg Biological
- Selected Regimen Biological
Biological
Eligibility (public fields only)
- Age range
- 60 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 5, 2018
- Primary completion
- May 15, 2022
- Completion
- May 15, 2022
- Last update posted
- May 24, 2025
2018 – 2022
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Optimal Research | Huntsville | Alabama | 35802 | — |
| Optimal Research | San Diego | California | 92108 | — |
| Optimal Research | Melbourne | Florida | 32934 | — |
| Optimal Research | Peoria | Illinois | 61614 | — |
| Optimal Research | Rockville | Maryland | 20850 | — |
| Optimal Research | Austin | Texas | 78705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03502707, 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 24, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03502707 live on ClinicalTrials.gov.