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

NCT03330899 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2020-09-30

No results posted yet for this study

Summary

The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen formulated with 2 different adjuvants .

Conditions

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)

Sponsors & Collaborators

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Esper Kallas, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2020-01-30
Completion
2020-08-25

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03330899 on ClinicalTrials.gov