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NCT05329220 · ClinicalTrials.gov registry record · Phase 3
ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2
A Phase 3 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,205
- Enrollment target
NCT05329220 is a Phase 3 study that has completed, run by Bavarian Nordic. The registered enrollment target is 4,205 participants.
The verdict
NCT05329220, a Phase 3 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,205 participants
- Enrollment target
Study Summary
This trial is composed of a randomized, double-blind, active controlled component (Part A) and an open-label, single-arm component (Part B) conducted in parallel. Part A is designed to compare vaccination with a single 100 µg dose of ABNCoV2 to a single 30 µg adult booster dose of Comirnaty (active control) in adult subjects who either previously completed primary vaccination (Cohort 1) or have already received 1 booster dose (Cohort 2) of SARS-CoV-2 locally authorized vaccine(s), and whose last locally authorized SARS-CoV-2 vaccination was at least 3 months prior to the screening visit. Subjects will be randomized in a 1:1 ratio to receive either ABNCoV2 or Comirnaty. Part B is designed to collect ABNCoV2 safety and tolerability data from a larger population of adult subjects, as well as additional immunogenicity data from a subset. Part B involves vaccination with the same single 100 µg dose of ABNCoV2 in the same population of adult subjects as the randomized component, and subjects will similarly be enrolled into 2 cohorts according to whether they have completed primary vaccination only or primary plus booster vaccination.
Interventions
- BIOLOGICAL Comirnaty
- BIOLOGICAL ABNCoV2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,205 participants |
| Start Date | 2022-08-30 |
| Est. Completion | 2023-10-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05329220
The ClinicalTrials.gov registry entry for NCT05329220 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bavarian Nordic, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Comirnaty is the first listed.
NCT05329220 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05329220 about?
NCT05329220 is a clinical study titled "ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2". This trial is composed of a randomized, double-blind, active controlled component (Part A) and an open-label, single-arm component (Part B) conducted in parallel. Part A is designed to compare vaccination with a single 100 µg dose of ABNCoV2 to a single 30 µg adult booster dose of Comirnaty (active...
What is the current status of trial NCT05329220?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,205 participants. The study started on 2022-08-30. Estimated completion is 2023-10-05.
What interventions are being tested in trial NCT05329220?
The interventions under investigation include: Comirnaty (BIOLOGICAL), ABNCoV2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05329220?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
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