Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT03502707 is a Phase 1 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 669 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1015% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspec
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 |
What the finished NCT03502707 record still lists
NCT03502707 is an interventional study that assigns participants to a tested intervention. The registered 669 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 (1015% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03502707 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03502707's enrollment target sits among peer trials
669 22nd of 2000 higher than 1,979 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02984761 · 670 participants · NA
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
- NCT05727904 · 670 participants · Phase 3
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
- NCT06223867 · 670 participants · NA
Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part A
- NCT04155034 · 668 participants · Phase 3
S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI