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A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine

NCT03369808 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2024-10-15

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 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.

Conditions

  • H7N9 Influenza

Interventions

BIOLOGICAL

7.5μg 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

Phosphate Buffer Solution

0.5ml phosphate buffer solution

BIOLOGICAL

Aluminum Hydroxide Adjuvant

0.5ml aluminum hydroxide adjuvant

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

30μg 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.

Sponsors & Collaborators

  • Henan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Ze Chen, PhD · Shanghai Institute Of Biological Products

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-29
Primary Completion
2018-08-29
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 NCT03369808 on ClinicalTrials.gov