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Completed

NCT Number: NCT02640989

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.

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Key information

Age range

18 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Disease Prevention and Control of Beijing Military Region

Beijing, Beijing Municipality, 100042, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Seasonal trivalent influenza vaccine, Anflu®

Biological

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

Other names: Anflu®

Seasonal trivalent influenza vaccine, VAXIGRIP

Biological

Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur

Other names: VAXIGRIP

Seasonal trivalent influenza vaccine, Fluarix

Biological

Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals

Other names: Fluarix

Primary outcomes

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

    Time frame: 21 days after vaccination

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

Secondary outcomes

  1. The incidences of adverse events (AEs)

    Time frame: 21 days after vaccination

    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).

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

    Time frame: 21 days after vaccination

    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.

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

    Time frame: 21 days after vaccination

    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.

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

    Time frame: 21 days after vaccination

    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.

Sponsors and collaborators

Lead sponsor

Center for Disease Prevention and Control of Beijing Military Region

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 29, 2015
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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