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First received: August 04, 2023

Clinical Trial: A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Monkeypox

Study Type: INTERVENTIONAL


Official Title: A Randomized, Partially Observer-blind, Dose-escalation, Phase I/II Trial Evaluating the Safety and Immunogenicity of Investigational RNA-based Mpox Vaccine Candidates

Brief Summary: This is a dose-escalation, Phase I/II study evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox (mpox).This study started with substudy A (SSA) and substudy B (SSB) for which recruitment has been completed.A Substudy C (SSC) was planned, but the sponsor decided not to conduct it.This study will therefore continue with substudy D (SSD).In SSA and SSB, dosing started with an…

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