Double-blind, Randomized Clinical Trial With Active Controls to Assess Safety, Immunogenicity and Lot-to-lot Consistency of Inactivated Split-virion Quadrivalent Influenza Vaccine of Butantan Institute
Status: Completed
Location: See all (12) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Studies have shown that a broader spectrum influenza vaccine may help in reducing the influenza burden of disease. Butantan Institute is currently developing a quadrivalent influenza vaccine candidate. This study is will provide safety and immunogenicity data on this quadrivalent influenza vaccine candidate. The study will be conducted in an open population of healthy participants (3 years old and above) recruited in different clinical sites in Brazil and will be adequately powered to assess safety, immune response (measured by GMT HI antibodies) to each viral strain in the vaccines and lot-to-lot consistency.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Healthy Volunteers: t
View:
• Male or female, age 3 years or older at the time of enrollment.
• Provide written informed consent
• Agrees to complete all study visits, procedures and contacts
• Women and adolescents of childbearing age: Negative pregnancy test with understanding (through informed consent process).
Locations
Other Locations
Brazil
Centro de Pesquisa e desenvolvimento de fármacos (Site BHZ01)
Belo Horizonte
Centro de Pesquisa Clínica Universidade Federal do Ceará - UFC (Site FOR01)
Fortaleza
Núcleo de Pesquisa e Desenvolvimento de Medicamentos - NPDM - Universidade Federal do Ceará - UFC (Site FOR 01)
Fortaleza
Centro de Pesquisas Clínicas da Universidade Federal de Sergipe (Site AJU01)
Laranjeiras
Centro de Pesquisa Clínica Hospital Escola da Universidade Federal de Pelotas (Site PET01)
Pelotas
Centro de Pesquisa Clínica do Hospital São Lucas da PUCRS (Site POA01)
Porto Alegre
Centro de Pesquisa Clínica Real Hospital Português de Beneficência em Pernambuco (Site REC01)
Recife
Centro de Pesquisa Clínica Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (FMRPUSP) (Site RAO01)
Ribeirão Preto
Centro de Pesquisa Clínica da Universidade Municipal de São Caetano do Sul (Site SCS01)
São Caetano Do Sul
Centro de Pesquisa Clínica Fundação Faculdade Regional de Medicina de São José do Rio Preto (Site SJP01)
São José Do Rio Preto
Centro de Pesquisas Clínicas do Instituto Central da FMUSP Unidade II (Site SAO01)