Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.
Public ClinicalTrials.gov record NCT02593071. 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 II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.
Study identification
- NCT ID
- NCT02593071
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,330 participants
Conditions and interventions
Conditions
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
- Sep 30, 2015
- Primary completion
- Oct 31, 2016
- Completion
- Oct 31, 2016
- Last update posted
- May 26, 2022
2015 – 2016
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nothern California Clinical Research | Redding | California | 96001 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | — |
| Rapid Medical Research | Cleveland | Ohio | 44122 | — |
| Clinical Research Associates | Nashville | Tennessee | 37203 | — |
| Research Across America | Dallas | Texas | 75234 | — |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| Group Health Research Institute | Seattle | Washington | 98101 | — |
| Marshfield Clinical Research Foundation | Wausau | Wisconsin | 54401 | — |
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 NCT02593071, 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 26, 2022 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02593071 live on ClinicalTrials.gov.