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A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine

NCT03755427 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2024-10-16

No results posted yet for this study

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.

Conditions

  • H7N9 Influenza

Interventions

BIOLOGICAL

15μg H7N9 Vaccine

The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.

BIOLOGICAL

Aluminum Hydroxide Adjuvant

The seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant.

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Xia Shengli, PhD · Henan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-10
Primary Completion
2019-01-05
Completion
2019-11-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03755427 on ClinicalTrials.gov