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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects

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Trial Profile

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 08 May 2023

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At a glance

  • Drugs COVID-19 vaccine-Gamaleya National Research Center of Epidemiology and Microbiology (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Dr Reddys Laboratories

    • Most Recent Events

    • 31 May 2021 Status changed from recruiting to active, no longer recruiting.
    • 13 Apr 2021 According to a Dr Reddys Laboratories media release, the company has received the permission from the Drug Controller General of India (DCGI) to import the Sputnik vaccine into India for restricted use in emergency situations as per the provisions of the New Drug and Clinical Trials rules, 2019 under the Drugs and Cosmetics Act.
    • 19 Feb 2021 According to a Dr Reddys Laboratories media release, the company has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V.As part of the review process, the company will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21st Feb 2021.

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