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NCT04713553 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
A Phase 3 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,574
- Enrollment target
NCT04713553 is a Phase 3 study that has completed, run by BioNTech SE. The registered enrollment target is 1,574 participants.
The verdict
NCT04713553, a Phase 3 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,574 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, observer-blind study in healthy individuals. The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2): * As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches) * As a 20-microgram dose, administered from 1 of the manufacturing lots * As a 2-dose (separated by 21 days) schedule * In people 12 through 50 years of age The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2 RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351): * Each as a 30-microgram dose * Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2 * In people 18 through 50 years of age
Interventions
- BIOLOGICAL BNT162b2
- BIOLOGICAL BNT162b2.B.1.351
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,574 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2021-07-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04713553
The ClinicalTrials.gov registry entry for NCT04713553 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,574 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BNT162b2 is the first listed.
NCT04713553 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04713553 about?
NCT04713553 is a clinical study titled "A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants". This is a Phase 3, randomized, observer-blind study in healthy individuals. The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2): * As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches) * As a 20-mic...
What is the current status of trial NCT04713553?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,574 participants. The study started on 2021-02-15. Estimated completion is 2021-07-22.
What interventions are being tested in trial NCT04713553?
The interventions under investigation include: BNT162b2 (BIOLOGICAL), BNT162b2.B.1.351 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04713553?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
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