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

Center for Disease Prevention and Control of Beijing Military Region292 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

292

Conditions

Influenza

Interventions

Seasonal trivalent influenza vaccine, Anflu®BIOLOGICAL

Seasonal trivalent influenza vaccine manufactured by Sinovac Co., Ltd.

Seasonal trivalent influenza vaccine, VAXIGRIPBIOLOGICAL

Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur

Seasonal trivalent influenza vaccine, FluarixBIOLOGICAL

Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals

Eligibility

Sex: ALLMin age: 18 YearsMax age: 34 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Center for Disease Prevention and Control of Beijing Military Region

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Hemagglutination inhibition (HI) titers of each strain which were recommended by WHO for the 2014 seasonal influenza vaccines

Hemagglutination inhibition (HI) titers were measured using the antigen and standard serum provided by the National Institute for Biological Standards and Control (NIBSC).

Time frame: 21 days after vaccination

Secondary Outcomes

The incidences of adverse events (AEs)

After vaccination, occurrences of AEs were collected till day 21. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination).

Time frame: 21 days after vaccination

The post-vaccination seroprotection rates of each of the influenza vaccines

Hemagglutination inhibition (HI) titers were used to calculate post-vaccination seroprotection rates of each of the influenza vaccines. By European Committee(European criteria): in adults aged between 18 to 60, post-vaccination seroprotection rates should be ≥ 70% for all vaccine strains.

Time frame: 21 days after vaccination

The post-vaccination seroconversion rates of each of the influenza vaccines

Hemagglutination inhibition (HI) titers were used to calculate post-vaccination seroconversion rates of each of the influenza vaccines. By European Committee(European criteria): in adults aged between 18 to 60, post-vaccination seroconversion rates should be \> 40% for all vaccine strains.

Time frame: 21 days after vaccination

The post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines

Hemagglutination inhibition (HI) titers were used to calculate post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines. By European Committee(European criteria): in adults aged between 18 to 60, post-vaccination mean geometric increases (GMIs) should be ≥ 2.5 for all vaccine strains.

Data from ClinicalTrials.gov

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