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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Seasonal trivalent influenza vaccine, Anflu®

Seasonal trivalent influenza vaccine, VAXIGRIP

Seasonal trivalent influenza vaccine, Fluarix

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza Vaccine, Safety, Immunogenicity

Eligibility Criteria

18 Years - 34 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

Center for Disease Prevention and Control of Beijing Military Region

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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.

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.

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.

Full Information

NCT ID

NCT02640989

First Posted

December 4, 2015

Last Updated

December 22, 2015

Sponsor

Center for Disease Prevention and Control of Beijing Military Region

1. Study Identification

Unique Protocol Identification Number

NCT02640989

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Center for Disease Prevention and Control of Beijing Military Region

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza Vaccine, Safety, Immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

292 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2

Arm Type

Experimental

Arm Description

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

Arm Title

Group 3

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Seasonal trivalent influenza vaccine, Anflu®

Other Intervention Name(s)

Anflu®

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Seasonal trivalent influenza vaccine, VAXIGRIP

Other Intervention Name(s)

VAXIGRIP

Intervention Description

Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur

Intervention Type

Biological

Intervention Name(s)

Seasonal trivalent influenza vaccine, Fluarix

Other Intervention Name(s)

Fluarix

Intervention Description

Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

21 days after vaccination

Secondary Outcome Measure Information:

Title

The incidences of adverse events (AEs)

Description

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).

Time Frame

21 days after vaccination

Title

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

Description

Time Frame

21 days after vaccination

Title

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

Description

Time Frame

21 days after vaccination

Title

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

Description

Time Frame

21 days after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

34 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dongqi Gao, PhD

Organizational Affiliation

Center for Disease Prevention and Control of Beijing Military Region

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Disease Prevention and Control of Beijing Military Region

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100042

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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