Safety and Immunogenicity of Three Seasonal Trivalent Influenza Vaccines in China Military

Center for Disease Prevention and Control of Beijing Military Region

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Seasonal trivalent influenza vaccine, Anflu®; Biological: Seasonal trivalent influenza vaccine, VAXIGRIP; Biological: Seasonal trivalent influenza vaccine, Fluarix

Study type: Interventional

Funder types: Other

Identifiers

NCT02640989

PRO-INF-BJJQ-01

Details and patient eligibility

About

The purpose of this study is to assess the safety and immunogenicity of three seasonal trivalent influenza vaccines (TIVs)manufactured by Glaxosmith Kline (GSK), Beijing Sinovac Biotech (Sinovac) and Shenzhen Sanofi Pasteur (Pasteur) in Chinese healthy servicemen. Using imported GSK's TIV as control, to compare it with other two domestic TIVs in Chinese healthy servicemen.

Full description

This study is a 1:1:1 randomized, double-blinded, controlled phase Ⅳ clinical trial in a military command in Beijing. Healthy individuals aged between 18～34 years who had not received any influenza vaccine during recent three years will be enrolled and administrated one dose TIV. Safety data will be collected for whole study (Day 0 to Day 30).Blood samples will be collected for immunogenicity assessments before injection and 21 days after vaccination.

Enrollment: 292 patients

Sex: All

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy servicemen aged between 18-34 years ,who had not received any influenza vaccine during recent three years;
• Proven legal identity;
• Written informed consent;
• Complying with the requirement of the study protocol;

Exclusion criteria

• Pregnant, breast feeding women;
• History of allergy to any vaccine or vaccine ingredient;
• Receipt of any immunosuppressant within 6 month prior to study entry;
• Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, Guillain-Barré syndrome, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor;
• Acute disease or acute stage of chronic disease within 7 days prior to study entry;
• Axillaty temperature > 37.0 °C;
• Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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292 participants in 3 patient groups

Group 1

Experimental group

Description:

* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Seasonal trivalent influenza vaccine, Anflu®

Treatment:

Biological: Seasonal trivalent influenza vaccine, Anflu®

Group 2

Experimental group

Description:

* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Seasonal trivalent influenza vaccine, VAXIGRIP

Treatment:

Biological: Seasonal trivalent influenza vaccine, VAXIGRIP

Group 3

Active Comparator group

Description:

* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Seasonal trivalent influenza vaccine, Fluarix

Treatment:

Biological: Seasonal trivalent influenza vaccine, Fluarix