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NCT02561871 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
A Phase 1 study, sponsored by Crucell Holland.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT02561871: Completed Phase 1 study, sponsored by Crucell Holland.
NCT02561871 is a Phase 1 study that has completed, run by Crucell Holland. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02561871, a Phase 1 study, has completed, sponsored by Crucell Holland.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of intramuscular prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) in healthy participants.
Primary Outcome
Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the participant diary.
Interventions
- DRUG Placebo
- BIOLOGICAL Ad35.RSV.FA2
- BIOLOGICAL Ad26.RSV.FA2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
What the finished NCT02561871 record still lists
NCT02561871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02561871 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02561871 about?
NCT02561871 is a clinical study titled "A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers". The purpose of this study is to assess the safety and tolerability of intramuscular prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) in healthy participants.
What is the current status of trial NCT02561871?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2015-09. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02561871?
The interventions under investigation include: Placebo (DRUG), Ad35.RSV.FA2 (BIOLOGICAL), Ad26.RSV.FA2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02561871?
This trial is sponsored by Crucell Holland, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02561871's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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