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NCT04999111 · ClinicalTrials.gov registry record · Phase 2
A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
A Phase 2 study of Coronavirus Disease, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 2
- Development phase
- 1,541
- Enrollment target
- 20
- Study locations
NCT04999111 is a Phase 2 study of Coronavirus Disease that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 1,541 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT04999111, a Phase 2 study of Coronavirus Disease, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,541 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purposes of this study are to demonstrate the non-inferiority (NI) of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels, administered greater than or equal to (\>=) 6 months after single-dose primary vaccination with Ad26.COV2.S, compared to the neutralizing antibody response to the original strain induced by single-dose primary vaccination with Ad26.COV2.S; To demonstrate the NI of the neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5\*10\^10 virus particle (vp) dose level, administered \>= 6 months after single-dose primary vaccination with Ad26.COV2.S (5\*10\^10 vp dose level), compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by single-dose primary vaccination with Ad26.COV2.S at the 5\*10\^10 vp dose level, if feasible; To demonstrate the NI of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels administered \>=6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the original strain induced by 2-dose primary vaccination with Pfizer BNT162b2; To demonstrate the NI of neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5\*10\^10 vp dose level, administered \>= 6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by 2-dose primary vaccination with Pfizer BNT162b2, if feasible.
Conditions Studied
Interventions
- BIOLOGICAL Ad26.COV2.S
Study Locations (20)
Florida
- Velocity Clinical Research, Hallandale Beach - Hallandale
- Research Centers of America, LLC - Hollywood
- Synexus Clinical Research US Inc - Orlando
- Synexus Clinical Research US Inc - The Villages
California
- Anaheim Clinical Trials, LLC - Anaheim
- Ark Clinical Research - Long Beach
- Velocity Clinical Research - North Hollywood
South Carolina
- Velocity Clinical Research, Anderson - Anderson
- Accellacare US Inc - Mt. Pleasant
- Coastal Carolina Research Center - North Charleston
Arizona
- Central Phoenix Medical Clinic - Phoenix
- Synexus Clinical Research US Inc - Tucson
Massachusetts
- Massachusetts General Hospital - Boston
- Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center - Boston
Illinois
- Optimal Research - Peoria
Kansas
- Johnson County Clin-Trials - Lenexa
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,541 participants |
| Start Date | 2021-08-06 |
| Est. Completion | 2022-11-22 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04999111
The ClinicalTrials.gov registry entry for NCT04999111 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,541 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 1 condition, with Coronavirus Disease appearing as the primary indexed condition, and to 1 intervention - of which Ad26.COV2.S is the first listed.
NCT04999111 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, South Carolina.
Frequently Asked Questions
What is clinical trial NCT04999111 about?
NCT04999111 is a clinical study titled "A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2". The purposes of this study are to demonstrate the non-inferiority (NI) of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels, administered greater than or equal to (\>=) 6 months after single-dose primary vaccinat...
What is the current status of trial NCT04999111?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,541 participants. The study started on 2021-08-06. Estimated completion is 2022-11-22.
What conditions does trial NCT04999111 study?
This clinical trial studies the following conditions: Coronavirus Disease.
What interventions are being tested in trial NCT04999111?
The interventions under investigation include: Ad26.COV2.S (BIOLOGICAL).
Who is sponsoring clinical trial NCT04999111?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04999111 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.