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

NCT02640989 | Completed Phase 4 DMC

• 1 other identifier: PRO-INF-BJJQ-01
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Keywords

Influenza Vaccine; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The incidences of adverse events (AEs)

  21 days after vaccination

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

  21 days after vaccination

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

  21 days after vaccination

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

  21 days after vaccination

Study Arms (3)

Group 1

EXPERIMENTAL

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

Biological: Seasonal trivalent influenza vaccine, Anflu®

Group 2

EXPERIMENTAL

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

Biological: Seasonal trivalent influenza vaccine, VAXIGRIP

Group 3

ACTIVE COMPARATOR

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

Biological: Seasonal trivalent influenza vaccine, Fluarix

Interventions

Seasonal trivalent influenza vaccine, Anflu® BIOLOGICAL

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

Also known as: Anflu®

Group 1

Seasonal trivalent influenza vaccine, VAXIGRIP BIOLOGICAL

Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur

Also known as: VAXIGRIP

Group 2

Seasonal trivalent influenza vaccine, Fluarix BIOLOGICAL

Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals

Also known as: Fluarix

Group 3

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Center for Disease Prevention and Control of Beijing Military Region: lead

Study Sites (1)

Center for Disease Prevention and Control of Beijing Military Region

Beijing, Beijing Municipality, 100042, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip; fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Dongqi Gao, PhD

  Center for Disease Prevention and Control of Beijing Military Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 29, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: April 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

CN (1)