The National Health Surveillance Agency (Anvisa) published, this Thursday (16), the authorization for the start of the Phase III clinical trial of the tetravalent influenza vaccine (fragmented and inactivated) QIV-IB, developed by the Butantan Institute, from Sao Paulo.
The study intends to evaluate the immunogenicity and safety of the vaccine in infants and children aged six to 35 months. According to the agency, the difference between the clinical trial approved today (FLQ-02-IB) and the previous one (FLQ-01-IB), in February, is the age of the participants.
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While in the first the participants would have to be three years old or older, in the clinical trial approved now (FLQ-02-IB) participants between six and 35 months will be included, in addition to the vaccine dose adjusted for age.
The production process of the tetravalent vaccine is similar to that of the trivalent vaccine (fragmented and inactivated) by the Butantan Institute (TIV-IB), which is already used in national vaccination campaigns against Influenza flu, by the National Immunization Program (PNI)/Ministry of Health.
While one of the trivalent vaccines contains the B virus (Yamagata lineage – TIV-Y-IB) and the other the influenza B virus (Victoria lineage – TIV-V-IB), the tetravalent vaccine has both strains of the B lineage in the same formulation .
“In this way, it is expected to obtain a tetravalent influenza vaccine analogous to the trivalent one, but with additional protection against a second B strain, determined seasonally by the World Health Organization (WHO). The addition of the second B strain of influenza (fourth strain in the vaccine) occurred in the transition from the bivalent seasonal influenza vaccine to the trivalent one, after the H1N1 influenza pandemic in 2009”, explained Anvisa.
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According to the clinical protocol, the idea is to include around 1,900 participants – between 6 and 35 months – in 10 centers distributed between São Paulo, Roraima, Sergipe and Pernambuco. Participation time will be approximately six months after the complete vaccination course, while the total estimated study time will be approximately 12 months.
clinical trials
Clinical trials are studies of a new drug performed on human beings. The clinical phase serves to demonstrate the safety and efficacy of the investigational drug for the proposed indication. If there is proof that the benefits outweigh the risks, the experimental drug may be registered by Anvisa and made available in the Brazilian market, provided there is a request by the company that develops/sponsors the clinical development.
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