drugset / Trial / NCT04537949

A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults

NCT04537949 ↗

Phase 1/2 Completed 96 enrolled BioNTech SE
Non-randomizedSequentialOpen-labelPrevention

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.

Timeline

Start
2020-09-09
Primary completion
2021-03-12
Completion
2022-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject GANULAMERAN Messenger RNA (mRNA) — Intramuscular

Indications