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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Seasonal trivalent influenza vaccine, Anflu®; Biological: Seasonal trivalent influenza vaccine, VAXIGRIP; Biological: Seasonal trivalent influenza vaccine, Fluarix

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100042
      • Center for Disease Prevention and Control of Beijing Military Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 32 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; Seasonal trivalent influenza vaccine, Anflu®	Biological: Seasonal trivalent influenza vaccine, Anflu®; Seasonal trivalent influenza vaccine manufactured by Sinovac Co., Ltd.; Other Names: Anflu®
Experimental: Group 2; Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; Seasonal trivalent influenza vaccine, VAXIGRIP	Biological: Seasonal trivalent influenza vaccine, VAXIGRIP; Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur; Other Names: VAXIGRIP
Active Comparator: Group 3; Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; Seasonal trivalent influenza vaccine, Fluarix	Biological: Seasonal trivalent influenza vaccine, Fluarix; Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals; Other Names: Fluarix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	21 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	21 days after vaccination

Collaborators and Investigators

• Sponsor: Center for Disease Prevention and Control of Beijing Military Region
• Investigators: Principal Investigator: Dongqi Gao, PhD, Center for Disease Prevention and Control of Beijing Military Region

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Estimate): December 29, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; Influenza Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-INF-BJJQ-01