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A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine - Trial NCT03755427

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.

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NCT03755427
Phase 2
biological
Trial Details
ClinicalTrials.gov โ€ข NCT03755427
View on ClinicalTrials.gov
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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

Study Focus

H7N9 Influenza

15ฮผg H7N9 Vaccine

Interventional

biological

Sponsor & Location

Shanghai Institute Of Biological Products

Zhumadian, China

Timeline & Enrollment

Phase 2

Nov 01, 2018

Jan 01, 2020

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 ฮผg 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 identified
Haemophilus influenzae infection, unspecified site
Haemophilus influenzae [H. influenzae] as the cause of diseases classified to other chapters
Influenza with other manifestations, virus not identified
Influenza due to identified seasonal influenza virus

Data Source

ClinicalTrials.gov

NCT03755427

Non-Device Trial