A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine - Trial NCT03369808
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.
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Study Focus
Sponsor & Location
Shanghai Institute Of Biological Products
Timeline & Enrollment
Early Phase 1
Dec 29, 2017
Aug 29, 2019
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 ฮผg,15 ฮผg and 30 ฮผg 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
Data Source
ClinicalTrials.gov
NCT03369808
Non-Device Trial