Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by BioNTech SE.
NCT04713553 is a Phase 3 study that has completed, run by BioNTech SE. The registered enrollment target is 1,574 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (104% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Geometric mean concentration of full-length S-binding IgG level for individual US lots (US lots 1, 2, and 3) was determined and reported in the descriptive section. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratio of Geometric Mean Concentrations (GMCs) of individual US Lots BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3.
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 |
What the finished NCT04713553 record still lists
NCT04713553 is an interventional study that assigns participants to a tested intervention. Its 1,574 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 (104% higher).
The record links to 0 conditions, and to 2 interventions - of which BNT162b2 is the first listed.
NCT04713553 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04713553's enrollment target sits among peer trials
1,574 149th of 2000 higher than 1,852 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06445946 · 1,572 participants · Phase 4
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
- NCT05483855 · 1,580 participants
Telehealth-delivered HealthcaRe to ImproVe Care
- NCT06034080 · 1,566 participants · NA
Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
- NCT06881069 · 1,560 participants · NA
Reach Through Equitable Implementation in Utah
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI