RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly
Public ClinicalTrials.gov record NCT01709019. 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 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum Adjuvant, and Co-administered With a Licensed Inactivated Influenza Vaccine, in Healthy Subjects ≥ 60 Years of Age.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is anticipated that some of the randomized study subjects may not complete the study; subjects who withdraw or are discontinued, will not be replaced. Randomization will be stratified by age (60 to \<75 years and ≥ 75 years) in order to distribute the proportion of such persons in each age group equally across treatment groups. Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A rescue dose of the licensed TIV will be provided to subjects in all groups except the placebo group on Day 28, the placebo group will receive saline. For each subject, study follow-up will span approximately one year from the first immunization (on Day 0) for all subjects.
Study identification
- NCT ID
- NCT01709019
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 220 participants
Conditions and interventions
Conditions
Interventions
- Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28) Biological
- Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28) Biological
- High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28) Biological
- High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28) Biological
- Placebo (Day 0 & Day 28); Seasonal TIV (Day 0) 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
- Sep 30, 2012
- Primary completion
- Jun 30, 2013
- Completion
- Feb 28, 2014
- Last update posted
- Mar 4, 2014
2012 – 2014
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Genova Clinical Research | Tucson | Arizona | 85704 | — |
| Accelovance | Melbourne | Florida | 32935 | — |
| Research Across America | Dallas | Texas | 75234 | — |
| Jean Brown Research | Salt Lake City | Utah | 84124 | — |
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 NCT01709019, 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 Mar 4, 2014 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01709019 live on ClinicalTrials.gov.