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NCT03502707 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
A Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 1
- Development phase
- 669
- Enrollment target
NCT03502707 is a Phase 1 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 669 participants.
The verdict
NCT03502707, a Phase 1 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 669 participants
- Enrollment target
Study Summary
The purpose of this study for: Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3. Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen. Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Ad26.RSV.preF 1*10^11 vp
- BIOLOGICAL RSV preF Protein 50 mcg
- BIOLOGICAL RSV preF Protein 150 mcg
- BIOLOGICAL Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 669 participants |
| Start Date | 2018-07-06 |
| Est. Completion | 2022-05-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03502707
The ClinicalTrials.gov registry entry for NCT03502707 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 669 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 5 interventions - of which Placebo is the first listed.
NCT03502707 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03502707 about?
NCT03502707 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older". The purpose of this study for: Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3. Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neut...
What is the current status of trial NCT03502707?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 669 participants. The study started on 2018-07-06. Estimated completion is 2022-05-16.
What interventions are being tested in trial NCT03502707?
The interventions under investigation include: Placebo (BIOLOGICAL), Ad26.RSV.preF 1*10^11 vp (BIOLOGICAL), RSV preF Protein 50 mcg (BIOLOGICAL), RSV preF Protein 150 mcg (BIOLOGICAL), Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg (BIOLOGICAL).
Who is sponsoring clinical trial NCT03502707?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
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