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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: RECRUITING

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 randomized, partially observer-blind, dose-escalation, Phase I/II trial evaluating the safety, tolerability, reactogenicity and immunogenicity of investigational RNA-based multivalent vaccine candidates (BNT166a and BNT166c) for active immunization against monkeypox (mpox).This trial will start with the two substudies, i.e., substudy A (SSA) and substudy B (SSB).This trial will be initiated with the dose-escalation SSA.In each substudy, dosing will start with an initial sentinel group, followed by…

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