A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine

H7N9 Influenza Clinical Trial

Official title:
Immunogenicity And Safety Of An Alum-Adjuvanted Inactivated H7N9 Influenza Vaccine

Status Active, not recruiting

Clinical Trial 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 12-60 years, for a randomized, blind, placebo-controlled, age-stratified clinical study. The investigators designed three dosage groups: 7.5 μg,15 μg and 30 μg of hemagglutinin antigen. According to the age of the subjects, Each group was divided into different age subgroups. Phosphate buffer solution and Aluminum hydroxide adjuvant as placebo controls were both set up in the subgroups.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 were determined.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03369808
Study type	Interventional
Source	Shanghai Institute Of Biological Products
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	December 29, 2017
Completion date	August 29, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03330899` - Safety and Immunogencity of H7N9 Influenza Antigen With 2 Adjuvant Formulations in Healthy Adults in Brazil	Phase 1
Not yet recruiting	`NCT03755427` - A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine	Phase 2
Not yet recruiting	`NCT06417853` - Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP)	Phase 1
Completed	`NCT01928472` - Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years	Phase 1