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NCT03755427

A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine

Immunogenicity and Safety of an Alum-adjuvanted Inactivated H7N9 Influenza Vaccine: a Randomized, Blind, Placebo-controlled, a Phase II Clinical Trial
Shanghai Institute Of Biological Products·Phase 2·ClinicalTrials.gov·biological
View on ClinicalTrials.gov →
Study focus
Disease/Condition
H7N9 Influenza
Drug/Device/Intervention
15μg H7N9 Vaccine
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Shanghai Institute Of Biological Products
Location
Zhumadian, China
Timeline & enrollment
Phase
Phase 2
Start date
Nov 01, 2018
End date
Jan 01, 2020
Enrollment
560 participants
Primary outcome

Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)

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.

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
NCT03755427
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03755427 through Pure Global AI's free database. This Phase 2 trial is sponsored by Shanghai Institute Of Biological Products and is currently status unknown. The study focuses on H7N9 Influenza. Target enrollment is 560 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.