Immunogenicity and Safety of Butantan Quadrivalent Influenza Vaccine (Split Virion, Inactivated) in Infants and Children .

PHASE3CompletedINTERVENTIONAL
Enrollment

1,373

Participants

Timeline

Start Date

April 25, 2023

Primary Completion Date

September 12, 2024

Study Completion Date

August 2, 2025

Conditions
Influenza, Human
Interventions
BIOLOGICAL

Quadrivalent Influenza Vaccine (split virion, inactivated)

Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan (dose 0.25ml and 0.50ml)

BIOLOGICAL

Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage

Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage/dose 0.50ml

BIOLOGICAL

Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage

Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage/dose 0.25ml

Trial Locations (10)

Unknown

Instituto Auto Imune de Pesquisa e Educação Continuada - Real Hospital Português de Beneficência em Pernambuco (Site REC01), Recife

Centro de Pesquisa Clínica S (Site RAO03), Serrana

69304-015

Centro Oncológico de Roraima - CECOR (Site BVB-01), Boa Vista

49170-000

Centro de Pesquisas Clínicas da Universidade Federal de Sergipe (Site AJU01), Laranjeiras

14051-140

Hospital das Clínicas da Faculdade de Medicina Ribeirão Preto - USP (Site RAO 04), Ribeirão Preto

18040-425

CPMC Pesquisa Clínica - Clinica De Alergia Martti Antila Sorocaba, Sorocaba

13271-130

A2Z Clinical Centro Avançado de Pesquisa Clínica Ltda.(Site 001), Valinhos

01228-000

CPQuali Pesquisa Clínica Ltda (Site 002), São Paulo

01228-200

Instituto de Pesquisa PENSI (Site SAO09), São Paulo

05403-000

Centro de Pesquisa Clínica do Instituto da Criança - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (Site SAO08), São Paulo

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Fundação Butantan

UNKNOWN

lead

Butantan Institute

OTHER_GOV