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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: Completed Phase 2 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT03339713 is a Phase 2 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Humoral immune responses expressed by the geometric mean titers (GMTs) of HI antibody titers against each of four influenza vaccine strains (A/Michigan, A/Hong Kong, B/Brisbane and B/Phuket). Serum specimens were tested for the presence of HAI antibodies to influenza vaccine strains. The HAI assay was conducted using serum samples from participants.
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 |
What the finished NCT03339713 record still lists
NCT03339713 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03339713 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03339713's enrollment target sits among peer trials
180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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