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NCT04614948 · ClinicalTrials.gov registry record · Phase 3

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults

A Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..

Completed
Registry status
Phase 3
Development phase
31,835
Enrollment target

NCT04614948: Completed Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..

NCT04614948 is a Phase 3 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 31,835 participants, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (4034% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04614948, a Phase 3 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..

COMPLETED
Registry status
Phase 3
Development phase
31,835 participants
Enrollment target

Study Summary

The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes, safety, and immunogenicity in the different study cohorts in open-label phase.

Primary Outcome

Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription/polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate \>=20 breaths per minute (min) and symptoms such as shortness of brea

Interventions

  • OTHER Placebo
  • BIOLOGICAL Ad26.COV2.S

Trial Details

FieldValue
Enrollment Target 31,835 participants
Start Date 2020-11-12
Est. Completion 2023-06-18
Phase Phase 3
Janssen Vaccines & Prevention B.V.

34 total trials

What the finished NCT04614948 record still lists

NCT04614948 is an interventional study that assigns participants to a tested intervention. Its 31,835 participants enrollment target places it among the larger protocols in the corpus, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (4034% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04614948 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04614948 about?

NCT04614948 is a clinical study titled "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults". The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes, safety, and immunogen...

What is the current status of trial NCT04614948?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 31,835 participants. The study started on 2020-11-12. Estimated completion is 2023-06-18.

What interventions are being tested in trial NCT04614948?

The interventions under investigation include: Placebo (OTHER), Ad26.COV2.S (BIOLOGICAL).

Who is sponsoring clinical trial NCT04614948?

This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04614948's enrollment target sits among peer trials

31,835 6th of 2000 higher than 1,995 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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Source: ClinicalTrials.gov NCT04614948, the US trial registry maintained by the National Library of Medicine. NCT04614948 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.