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

NCT ID: NCT02710409

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3664 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Quadrivalent influenza vaccine

Group Type: EXPERIMENTAL

Quadrivalent influenza vaccine

Intervention Type: BIOLOGICAL

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

Trivalent influenza vaccine A

Active Comparator A

Group Type: ACTIVE_COMPARATOR

Trivalent influenza vaccine A

Intervention Type: BIOLOGICAL

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

Trivalent influenza vaccine B

Active Comparator B

Group Type: ACTIVE_COMPARATOR

Trivalent influenza vaccine B

Intervention Type: BIOLOGICAL

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

Interventions

Quadrivalent influenza vaccine

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

Intervention Type: BIOLOGICAL

Trivalent influenza vaccine A

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

Intervention Type: BIOLOGICAL

Trivalent influenza vaccine B

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Aged 3 years and older
• Healthy subjects judged from medical history and clinical examination
• Subjects themselves or their guardians able to understand and sign the informed consent
• Subjects themselves or their guardians can and will comply with the requirements of the protocol
• Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria

• Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
• Any prior administration of influenza vaccine in last 6 month
• Subject who is allergic to any ingredient of the vaccine
• Female subject aged ≥18 years with a positive result after urine pregnancy test or during pregnancy or baby nursing period
• Subject with damaged or low immune function which has already been known
• Subject who had a seasonal influenza medical history in last 6 months
• Subject with acute febrile illness or infectious disease
• Major congenital defects or serious chronic illness, including perinatal brain damage
• Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
• Subject who has serious allergic history
• Subject with other medical history not suitable for vaccination such as fainting during injection
• Any prior administration of immunodepressant or corticosteroids in last 6 months
• Any prior administration of blood products in last 3 months
• Any prior administration of other research medicine/vaccine in last 30 days
• Any prior administration of any attenuated live vaccine in last 30 days
• Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
• Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Jindike Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guanyun County Center for Disease Control and Prevention

Lianyungang, Jiangsu, China

Countries

China

Other Identifiers

JSVCT031

Identifier Type: -

Identifier Source: org_study_id