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A Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine in Healthy Subjects Aged 3 Years and Older

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Quadrivalent influenza vaccine

Trivalent influenza vaccine A

Trivalent influenza vaccine B

About this trial

This is an interventional prevention trial for Influenza focused on measuring safety, immunogenicity , quadrivalent influenza vaccine

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged 3 years and older
Healthy subjects judged from medical history and clinical examination
Subjects themselves or their guardians able to understand and sign the informed consent
Subjects themselves or their guardians can and will comply with the requirements of the protocol
Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria:

Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
Any prior administration of influenza vaccine in last 6 month
Subject who is allergic to any ingredient of the vaccine
Female subject aged ≥18 years with a positive result after urine pregnancy test or during pregnancy or baby nursing period
Subject with damaged or low immune function which has already been known
Subject who had a seasonal influenza medical history in last 6 months
Subject with acute febrile illness or infectious disease
Major congenital defects or serious chronic illness, including perinatal brain damage
Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
Subject who has serious allergic history
Subject with other medical history not suitable for vaccination such as fainting during injection
Any prior administration of immunodepressant or corticosteroids in last 6 months
Any prior administration of blood products in last 3 months
Any prior administration of other research medicine/vaccine in last 30 days
Any prior administration of any attenuated live vaccine in last 30 days
Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent

Sites / Locations

Guanyun County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Quadrivalent influenza vaccine

Trivalent influenza vaccine A

Trivalent influenza vaccine B

Arm Description

Active Comparator A

Active Comparator B

Outcomes

Primary Outcome Measures

the 95% confidence interval (CI) lower limit for the seroconversion against each corresponding flu strain after vaccination is≥40% in subjects aged 3-59 years and≥30% in subjects aged ≥60 years separately

Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.

incidence of solicited adverse reactions after vaccination

incidence of solicited adverse reactions (including systemic and local adverse reactions) after vaccination

Secondary Outcome Measures

the 95% CI lower limit for the post-vaccination seroprotection rates against each corresponding flu strain is ≥70%

A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.

the post-vaccination mean geometric increases (GMIs) of HAI titer against each corresponding flu strain is≥2.5 in subjects aged 3-59 years and≥2.0 in subjects aged ≥60 years separately

Hemagglutination inhibition (HI) titers were used to calculate post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines.

incidence of unsolicited adverse reactions after vaccination

incidence of unsolicited adverse reactions (including systemic and local adverse reactions) after vaccination

incidence of serious adverse event (SAE) after vaccination

Full Information

NCT ID

NCT02710409

First Posted

March 12, 2016

Last Updated

August 30, 2016

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Jiangsu Jindike Biotechnology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02710409

Brief Title

A Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine in Healthy Subjects Aged 3 Years and Older

Official Title

A Double-blind,Randomized,Positive-controlled, Non-inferiority Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Chinese Subjects Aged 3 Years and Older

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Jiangsu Jindike Biotechnology Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Influenza is an acute respiratory disease caused by influenza viruses. There are three types of the virus including A, B and C. Both type A and type B viruses can cause acute febrile respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough, sore throat, nasal congestion and general malaise. The main transmission of influenza is through those highly contagious aerosol droplets containing influenza virus passed from infected people to susceptible population. Each year in the fall and winter infection of influenza is widespread in various age groups, with high incidence rate. Although influenza is generally a self-limiting disease, but in children, the elderly (especially those above 65 years old and those with chronic heart, lung, kidney, liver, blood or metabolic diseases such as diabetes or other certain diseases) and those with poor immunity function, influenza can easily lead to serious flu complications such as pneumonia, resulting in severe increase of morbidity and mortality. In order to evaluate safety and immunogenicity of a quadrivalent influenza vaccine produced by Jiangsu Jindike Biotechnology Co., Ltd. a phase III clinical trial is planned to conduct in healthy Chinese subjects aged 3 years and older.

Detailed Description

Subjects will be randomized into three arms- Experimental Group, Active Comparator A and Active Comparator B by the ratio of 2:1:1.

6. Conditions and Keywords

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

Influenza

Keywords

safety, immunogenicity , quadrivalent influenza vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

3664 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Quadrivalent influenza vaccine

Arm Type

Experimental

Arm Title

Trivalent influenza vaccine A

Arm Type

Active Comparator

Arm Description

Active Comparator A

Arm Title

Trivalent influenza vaccine B

Arm Type

Active Comparator

Arm Description

Active Comparator B

Intervention Type

Biological

Intervention Name(s)

Quadrivalent influenza vaccine

Intervention Description

0.5 ml/vial, one dose, intramuscular injection on day 0

Intervention Type

Biological

Intervention Name(s)

Trivalent influenza vaccine A

Intervention Description

0.5 ml/vial, one dose, intramuscular injection on day 0

Intervention Type

Biological

Intervention Name(s)

Trivalent influenza vaccine B

Intervention Description

0.5 ml/vial, one dose, intramuscular injection on day 0

Primary Outcome Measure Information:

Title

Description

Time Frame

28 days after vaccination

Title

incidence of solicited adverse reactions after vaccination

Description

incidence of solicited adverse reactions (including systemic and local adverse reactions) after vaccination

Time Frame

0-7 days after vaccination

Secondary Outcome Measure Information:

Title

the 95% CI lower limit for the post-vaccination seroprotection rates against each corresponding flu strain is ≥70%

Description

A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.

Time Frame

28 days after vaccination

Title

the post-vaccination mean geometric increases (GMIs) of HAI titer against each corresponding flu strain is≥2.5 in subjects aged 3-59 years and≥2.0 in subjects aged ≥60 years separately

Description

Hemagglutination inhibition (HI) titers were used to calculate post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines.

Time Frame

28 days after vaccination

Title

incidence of unsolicited adverse reactions after vaccination

Description

incidence of unsolicited adverse reactions (including systemic and local adverse reactions) after vaccination

Time Frame

0-28 days after vaccination

Title

incidence of serious adverse event (SAE) after vaccination

Time Frame

0-28 days after vaccination

Title

incidence of serious adverse event (SAE) after vaccination

Time Frame

29 days to 6 month after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 3 years and older Healthy subjects judged from medical history and clinical examination Subjects themselves or their guardians able to understand and sign the informed consent Subjects themselves or their guardians can and will comply with the requirements of the protocol Subjects with temperature <=37.0°C on axillary setting Exclusion Criteria: Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease Any prior administration of influenza vaccine in last 6 month Subject who is allergic to any ingredient of the vaccine Female subject aged ≥18 years with a positive result after urine pregnancy test or during pregnancy or baby nursing period Subject with damaged or low immune function which has already been known Subject who had a seasonal influenza medical history in last 6 months Subject with acute febrile illness or infectious disease Major congenital defects or serious chronic illness, including perinatal brain damage Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection Subject who has serious allergic history Subject with other medical history not suitable for vaccination such as fainting during injection Any prior administration of immunodepressant or corticosteroids in last 6 months Any prior administration of blood products in last 3 months Any prior administration of other research medicine/vaccine in last 30 days Any prior administration of any attenuated live vaccine in last 30 days Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent

Facility Information:

Facility Name

Guanyun County Center for Disease Control and Prevention

City

Lianyungang

State/Province

Jiangsu

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

A Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine in Healthy Subjects Aged 3 Years and Older

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