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A Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine in Healthy Subjects Aged 3 Years and Older

NCT02710409 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3664

Last updated 2016-09-01

No results posted yet for this study

Summary

Influenza is an acute respiratory disease caused by influenza viruses. There are three types of the virus including A, B and C. Both type A and type B viruses can cause acute febrile respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough, sore throat, nasal congestion and general malaise. The main transmission of influenza is through those highly contagious aerosol droplets containing influenza virus passed from infected people to susceptible population. Each year in the fall and winter infection of influenza is widespread in various age groups, with high incidence rate. Although influenza is generally a self-limiting disease, but in children, the elderly (especially those above 65 years old and those with chronic heart, lung, kidney, liver, blood or metabolic diseases such as diabetes or other certain diseases) and those with poor immunity function, influenza can easily lead to serious flu complications such as pneumonia, resulting in severe increase of morbidity and mortality.

In order to evaluate safety and immunogenicity of a quadrivalent influenza vaccine produced by Jiangsu Jindike Biotechnology Co., Ltd. a phase III clinical trial is planned to conduct in healthy Chinese subjects aged 3 years and older.

Conditions

Interventions

BIOLOGICAL

Quadrivalent influenza vaccine

0.5 ml/vial, one dose, intramuscular injection on day 0

BIOLOGICAL

Trivalent influenza vaccine A

0.5 ml/vial, one dose, intramuscular injection on day 0

BIOLOGICAL

Trivalent influenza vaccine B

0.5 ml/vial, one dose, intramuscular injection on day 0

Sponsors & Collaborators

  • Jiangsu Jindike Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-06-30
Completion
2016-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT02710409 on ClinicalTrials.gov