Safety and Immunogencity of H7N9 Influenza Antigen With 2 Adjuvant Formulations in Healthy Adults in Brazil

PHASE1CompletedINTERVENTIONAL
Enrollment

432

Participants

Timeline

Start Date

September 24, 2018

Primary Completion Date

January 30, 2020

Study Completion Date

August 25, 2020

Conditions
InfluenzaH7N9 Influenza
Interventions
BIOLOGICAL

H7N9 antigen + adjuvant IB160

H7N9 monovalent (fragmented and inactivated)

BIOLOGICAL

H7N9 antigen + adjuvant SE

H7N9 monovalent (fragmented and inactivated)

BIOLOGICAL

H7N9 antigen without adjuvant

H7N9 monovalent (fragmented and inactivated)

BIOLOGICAL

Placebo (PBS)

Placebo (Phosphate Buffered Saline -PBS)

Trial Locations (3)

14015-069

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Ribeirão Preto

05403 000

Centro de Pesquisas Clínicas do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo

05415009

Centro de Pesquisa Clínica do Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - ICr/HCFMUSP, São Paulo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Butantan Institute

OTHER_GOV