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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640989
• Other study ID #: PRO-INF-BJJQ-01
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2015
• Last updated: December 22, 2015
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: Center for Disease Prevention and Control of Beijing Military Region
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: April 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 34 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Seasonal trivalent influenza vaccine, Anflu®
Seasonal trivalent influenza vaccine manufactured by Sinovac Co., Ltd.
• Seasonal trivalent influenza vaccine, VAXIGRIP
Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur
• Seasonal trivalent influenza vaccine, Fluarix
Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals

Locations

Country	Name	City	State
China	Center for Disease Prevention and Control of Beijing Military Region	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Center for Disease Prevention and Control of Beijing Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No