NCT02710409

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

A Double-blind,Randomized,Positive-controlled, Non-inferiority Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Chinese Subjects Aged 3 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,664 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

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.

Detailed description

Subjects will be randomized into three arms- Experimental Group, Active Comparator A and Active Comparator B by the ratio of 2:1:1.

Conditions

• Influenza

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-06-01
• Completion: 2016-08-01
• First posted: 2016-03-16
• Last updated: 2016-09-01

Locations

1 site across 1 country: China