drugset / Trial / NCT03755427

A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine

NCT03755427 ↗

Phase 2 Completed 560 enrolled Shanghai Institute Of Biological Products
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults. The investigators will test the vaccine in participants aged above 12 years, for a randomized, blind, placebo-controlled, clinical study. The investigators designed one dosage groups: 15 μg of hemagglutinin antigen. Control group is designed to inoculate seasonal influence vaccine and aluminum hydroxide adjuvant. Participants will receive 2 doses of vaccine at 21-day intervals. Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination will be determined.

Timeline

Start
2018-11-10
Primary completion
2019-01-05
Completion
2019-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject H7N9 Vaccine Vaccine 15 ug —
Comparator Aluminum Hydroxide Adjuvant Unknown 0.5 ml —

Indications