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NCT01709019 · ClinicalTrials.gov registry record · Phase 1
RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly
A Phase 1 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
NCT01709019: Completed Phase 1 study, sponsored by Novavax.
NCT01709019 is a Phase 1 study that has completed, run by Novavax. The registered enrollment target is 220 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01709019, a Phase 1 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post injection; all adverse events, solicited and unsolicited over 56 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year.
Interventions
- BIOLOGICAL 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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT01709019 record still lists
NCT01709019 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher).
The record links to 0 conditions, and to 5 interventions - of which Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28) is the first listed.
NCT01709019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01709019 about?
NCT01709019 is a clinical study titled "RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly". 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...
What is the current status of trial NCT01709019?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2012-10. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01709019?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT01709019?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01709019's enrollment target sits among peer trials
220 230th of 2000 higher than 1,763 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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