"Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial " by Valerie Lau
 

Document Type

Article Presentation

Original Publication Date

2021

Date of Submission

July 2021

Abstract

The article presentation summarized the design of the Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial by Ricardo Palacios et. al. The Sinnovac vaccine is manufactured by Sinovac Life Sciences in Beijing, China. It uses the inactivated vaccine where the genetic material of the pathogen is eliminated by heat, radiation, or other chemicals. This was a Phase III trial, and it included a large sample size of 13,060 participants. Healthy people or people with a compromised immune system, above 18 years old, including both genders, and were health care workers in close contact with COVID-19 patients were qualified as participants. There were two randomized groups. This included 11,800 participants (18-59 year-old) and 260 senior citizens (above 60 year-old). The primary purpose was to evaluate the incidence of symptomatic cases of COVID-19 two weeks after second injection and any adverse reactions one week after vaccination in both groups. During the discussion section of the meeting, it was mentioned that allowing citizens to choose which vaccine they prefer should not be permitted currently. The primary focus should be to reach the ideal immunity level. However, as the vaccine supply increases, there should be more freedom in choosing the vaccine a person prefers.

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