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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: Completed Phase 3 study, sponsored by Bavarian Nordic.
NCT05329220 is a Phase 3 study that has completed, run by Bavarian Nordic. The registered enrollment target is 4,205 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (445% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint was SARS-CoV-2 index virus (Wuhan wild type isolate) neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 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 |
What the finished NCT05329220 record still lists
NCT05329220 is an interventional study that assigns participants to a tested intervention. Its 4,205 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (445% higher).
The record links to 0 conditions, and to 2 interventions - of which Comirnaty is the first listed.
NCT05329220 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05329220's enrollment target sits among peer trials
4,205 59th of 2000 higher than 1,942 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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