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NCT03964415 · ClinicalTrials.gov registry record · Phase 3
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
A Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 3,900
- Enrollment target
NCT03964415: Completed Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT03964415 is a Phase 3 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 3,900 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (405% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03964415, a Phase 3 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,900 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.
Primary Outcome
Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Ad26.Mos4.HIV
- BIOLOGICAL Clade C and Mosaic gp140 HIV bivalent vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,900 participants |
| Start Date | 2019-10-31 |
| Est. Completion | 2023-08-10 |
| Phase | Phase 3 |
What the finished NCT03964415 record still lists
NCT03964415 is an interventional study that assigns participants to a tested intervention. Its 3,900 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (405% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03964415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03964415 about?
NCT03964415 is a clinical study titled "A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals". The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having ...
What is the current status of trial NCT03964415?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,900 participants. The study started on 2019-10-31. Estimated completion is 2023-08-10.
What interventions are being tested in trial NCT03964415?
The interventions under investigation include: Placebo (BIOLOGICAL), Ad26.Mos4.HIV (BIOLOGICAL), Clade C and Mosaic gp140 HIV bivalent vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03964415?
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 NCT03964415's enrollment target sits among peer trials
3,900 65th of 2000 higher than 1,936 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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