Status:

COMPLETED

Study of Sputnik V COVID-19 Vaccination in Adults in Kazakhstan

Lead Sponsor:

Karaganda Medical University

Collaborating Sponsors:

McMaster University

Conditions:

Covid19

Vaccine Adverse Reaction

Eligibility:

All Genders

18+ years

Brief Summary

This study will assess the safety, reactogenicity, and immunogenicity of Gam-COVID-Vac (Sputnik V) vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2...

Detailed Description

Sputnik V (Gam-COVID-Vac) is an adenoviral vector vaccine developed by The Gamaleya Research Institute of Epidemiology and Microbiology (Moscow, Russia), registered and approved by the Ministry of Hea...

Eligibility Criteria

Inclusion

  • Participant must be healthy (in the physician's clinical judgment and as confirmed by medical records, and physical examination at screening).
  • Willing to give informed consent, and answer short questionnaires on past exposure to COVID-19 and post-vaccination reactogenicity.
  • Willing to comply with the requirements of the protocol.

Exclusion

  • Participant shows signs of an acute illness (excluding minor illnesses such as diarrhea or mild upper respiratory tract infection).
  • Participant has a positive laboratory-confirmed test result for SARS-CoV-2 infection at screening.
  • Deemed by investigators to be unlikely to complete study protocol.

Key Trial Info

Start Date :

April 5 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 20 2023

Estimated Enrollment :

82 Patients enrolled

Trial Details

Trial ID

NCT04871841

Start Date

April 5 2021

End Date

June 20 2023

Last Update

April 12 2024

Active Locations (1)

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Karaganda Medical University

Karaganda, Kazakhstan, 100008