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NCT04765384 · ClinicalTrials.gov registry record · Phase 2
A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)
A Phase 2 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT04765384: Completed Phase 2 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT04765384 is a Phase 2 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04765384, a Phase 2 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule at the standard dose level in adult participants during the second and/or third trimester of pregnancy and (potentially) post-partum; to assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S administered IM as a 1-dose schedule during the second and/or third trimester of pregnancy, 28 days after vaccination.
Primary Outcome
Number of adult participants with solicited local AEs for 7 days post first vaccination was reported. 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. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted
Interventions
- BIOLOGICAL Ad26.COV2.S
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-08-27 |
| Est. Completion | 2023-11-24 |
| Phase | Phase 2 |
What the finished NCT04765384 record still lists
NCT04765384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Ad26.COV2.S is the first listed.
NCT04765384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04765384 about?
NCT04765384 is a clinical study titled "A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)". The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule at the standard dose level in adult participants during the second and/or third trimester of pregnancy and (potentially) post-partum; to assess the humoral immun...
What is the current status of trial NCT04765384?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2021-08-27. Estimated completion is 2023-11-24.
What interventions are being tested in trial NCT04765384?
The interventions under investigation include: Ad26.COV2.S (BIOLOGICAL).
Who is sponsoring clinical trial NCT04765384?
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 NCT04765384's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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