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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 is a Phase 3 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 3,900 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03964415
The ClinicalTrials.gov registry entry for NCT03964415 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,900 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 3 interventions - of which Placebo is the first listed.
NCT03964415 reports 0 study locations.
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.
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