NCT03369808

A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine

Name: Clinical Trial NCT03369808
Creator: Shanghai Institute Of Biological Products
Keywords: H7N9 Influenza, 7.5μg H7N9 Vaccine, Early Phase 1, biological, clinical trial, China

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

Shanghai Institute Of Biological Products·Early Phase 1·ClinicalTrials.gov·biological

View on ClinicalTrials.gov →

Study focus

Disease/Condition: H7N9 Influenza
Drug/Device/Intervention: 7.5μg H7N9 Vaccine
Study type: Interventional
Intervention type: biological

Sponsor & location

Primary sponsor: Shanghai Institute Of Biological Products
Location: Zhumadian, China

Timeline & enrollment

Phase: Early Phase 1
Start date: Dec 29, 2017
End date: Aug 29, 2019
Enrollment: 360 participants

Primary outcome

Reactogenicity Events

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.

ICD-10 classifications

Influenza, virus not identifiedHaemophilus influenzae infection, unspecified siteHaemophilus influenzae [H. influenzae] as the cause of diseases classified to other chaptersInfluenza with other manifestations, virus not identifiedInfluenza due to identified seasonal influenza virus

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT03369808
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT03369808 through Pure Global AI's free database. This Early Phase 1 trial is sponsored by Shanghai Institute Of Biological Products and is currently status unknown. The study focuses on H7N9 Influenza. Target enrollment is 360 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.