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

NCT ID: NCT02640989

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Influenza

Keywords

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Influenza Vaccine Safety Immunogenicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Seasonal trivalent influenza vaccine, Anflu®

Intervention Type BIOLOGICAL

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

Group 2

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

Group Type EXPERIMENTAL

Seasonal trivalent influenza vaccine, VAXIGRIP

Intervention Type BIOLOGICAL

Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur

Group 3

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

Group Type ACTIVE_COMPARATOR

Seasonal trivalent influenza vaccine, Fluarix

Intervention Type BIOLOGICAL

Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals

Interventions

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Seasonal trivalent influenza vaccine, Anflu®

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

Intervention Type BIOLOGICAL

Seasonal trivalent influenza vaccine, VAXIGRIP

Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur

Intervention Type BIOLOGICAL

Seasonal trivalent influenza vaccine, Fluarix

Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals

Intervention Type BIOLOGICAL

Other Intervention Names

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Anflu® VAXIGRIP Fluarix

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Disease Prevention and Control of Beijing Military Region

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dongqi Gao, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Disease Prevention and Control of Beijing Military Region

Locations

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Center for Disease Prevention and Control of Beijing Military Region

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PRO-INF-BJJQ-01

Identifier Type: -

Identifier Source: org_study_id