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NCT03339713 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health
A Phase 2 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
NCT03339713 is a Phase 2 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 180 participants.
The verdict
NCT03339713, a Phase 2 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the non-inferiority of the concomitant administration of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) and seasonal influenza vaccine versus the administration of seasonal influenza vaccine alone in terms of humoral immune response expressed by the geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, and to assess the safety and tolerability of a single dose of 1\*10\^11 viral particles (vp) of Ad26.RSV.preF, administered intramuscularly to participants aged greater than or equal to 60 years separately or concomitantly with seasonal influenza vaccine.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Fluarix
- BIOLOGICAL Ad26.RSV.preF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2018-07-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03339713
The ClinicalTrials.gov registry entry for NCT03339713 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Vaccines & Prevention B.V., which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03339713 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03339713 about?
NCT03339713 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health". The purpose of this study is to demonstrate the non-inferiority of the concomitant administration of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) and seasonal influenza vaccine versus the administration of seasonal influen...
What is the current status of trial NCT03339713?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2017-12-07. Estimated completion is 2018-07-23.
What interventions are being tested in trial NCT03339713?
The interventions under investigation include: Placebo (BIOLOGICAL), Fluarix (BIOLOGICAL), Ad26.RSV.preF (BIOLOGICAL).
Who is sponsoring clinical trial NCT03339713?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
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