CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
BNT162b3biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04537949
NCT04537949Phase 2Completed
CompareCT.gov

A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of a Prophylactic SARS-CoV-2 RNA Vaccine (BNT162b3) Against COVID-19 Using Different Dosing Regimens in Healthy Adults

BioNTech SE·interventional·Posted Sep 3, 2020·Updated Jan 5, 2024

In Brief

A Phase 2 clinical trial evaluating BNT162b3 for Covid-19 and Protection Against COVID-19. Completed, enrolled 96 participants across 2 sites.

Detailed Summary

Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was skipped due to changes in the overall clinical development plan. The conducted Part A was a dose-finding part to investigate the optimal dose, allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants were chosen based on acceptability of dosing in younger participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid-19, Protection Against COVID-19
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 3, 2020
Enrollment StartSep 9, 2020
Primary CompletionMar 12, 2021
Study CompletionFeb 7, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.8 years ago

Interventions

BNT162b3biological

Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen).