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A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine

Primary Purpose

H7N9 Influenza

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

15μg H7N9 Vaccine

Aluminum Hydroxide Adjuvant

About this trial

This is an interventional prevention trial for H7N9 Influenza focused on measuring H7N9

Eligibility Criteria

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

Inclusion Criteria:

Over the age of 12 years, healthy population
Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
To comply with the requirements of clinical trial program, receive blood test before and after immunization and cooperate with follow-up

Exclusion Criteria:

A history of influenza A (H7N9) virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes
Allergy to any component in the vaccine (allergy history of any previous vaccination), especially for egg allergy
History of asthma, history of thyroid resection, vascular nerve edema, diabetes mellitus, hypertension can not be controlled by medicine, liver and kidney diseases or malignant tumor history
Suffered from any serious illness, such as cancer, autoimmune disease, progressive atherosclerotic disease or complications of diabetes, chronic obstructive pulmonary disease, need oxygen therapy for acute or progressive liver or kidney disease, congestive heart-failure etc.
History of signs disease or symptoms of neurological symptoms
Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
Acute attacks of various acute or chronic diseases in the past 7 days
Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases
Congenital malformations or developmental disorders, genetic defects, severe malnutrition etc
No spleen, functional absence of spleen, and splenectomy or splenectomy without any condition
Autoimmune diseases or immunodeficiency have been treated with immunosuppressive agents in the past 6 months
History of epilepsy, convulsions, or a family history of psychosis
Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy
The blood products were received within 3 months prior to the acceptance of the vaccine
Received a live vaccine within 14 days prior to receiving the vaccine, or received a subunit or inactivated vaccine within 7 days
Fever within 3 days prior to vaccination, axillary temperature ≥38 ℃
Being febrile When inoculating vaccine, axillary temperature >37.0 ℃
Women are pregnant or in the near future planned pregnancy or pregnancy test positive
Participants in another clinical trial

Sites / Locations

Suiping Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

15μg H7N9 Vaccine

Aluminum hydroxide adjuvant

Arm Description

Participants will be inoculated with 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.

Participants will be first inoculated with one dose of seasonal influenza vaccine and followed with one dose of aluminum hydroxide adjuvant at 21-day intervals.

Outcomes

Primary Outcome Measures

Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)

For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval

Secondary Outcome Measures

Number of participants that presented seroconversion post injection

Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing

Number of participants that presented seroprotection post injection

Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing

Geometric mean of Hemagglutination-inhibition titre post first study injection

Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.

Full Information

NCT ID

NCT03755427

First Posted

November 14, 2018

Last Updated

November 27, 2018

Sponsor

Shanghai Institute Of Biological Products

1. Study Identification

Unique Protocol Identification Number

NCT03755427

Brief Title

A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine

Official Title

Immunogenicity and Safety of an Alum-adjuvanted Inactivated H7N9 Influenza Vaccine: a Randomized, Blind, Placebo-controlled, a Phase II Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2018 (Anticipated)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Institute Of Biological Products

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults. The investigators will test the vaccine in participants aged above 12 years, for a randomized, blind, placebo-controlled, clinical study. The investigators designed one dosage groups: 15 μg of hemagglutinin antigen. Control group is designed to inoculate seasonal influence vaccine and aluminum hydroxide adjuvant. Participants will receive 2 doses of vaccine at 21-day intervals. Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination will be determined.

6. Conditions and Keywords

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

H7N9 Influenza

Keywords

H7N9

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

15μg H7N9 Vaccine

Arm Type

Experimental

Arm Description

Participants will be inoculated with 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.

Arm Title

Aluminum hydroxide adjuvant

Arm Type

Placebo Comparator

Arm Description

Participants will be first inoculated with one dose of seasonal influenza vaccine and followed with one dose of aluminum hydroxide adjuvant at 21-day intervals.

Intervention Type

Biological

Intervention Name(s)

15μg H7N9 Vaccine

Intervention Description

The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.

Intervention Type

Biological

Intervention Name(s)

Aluminum Hydroxide Adjuvant

Intervention Description

The seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant.

Primary Outcome Measure Information:

Title

Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)

Description

For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval

Time Frame

Continuous observation for 30 days after two inoculations

Secondary Outcome Measure Information:

Title

Number of participants that presented seroconversion post injection

Description

Time Frame

21 days after two inoculations

Title

Number of participants that presented seroprotection post injection

Description

Time Frame

21 days after two inoculations

Title

Geometric mean of Hemagglutination-inhibition titre post first study injection

Description

Time Frame

21 days after two inoculations

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over the age of 12 years, healthy population Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required To comply with the requirements of clinical trial program, receive blood test before and after immunization and cooperate with follow-up Exclusion Criteria: A history of influenza A (H7N9) virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes Allergy to any component in the vaccine (allergy history of any previous vaccination), especially for egg allergy History of asthma, history of thyroid resection, vascular nerve edema, diabetes mellitus, hypertension can not be controlled by medicine, liver and kidney diseases or malignant tumor history Suffered from any serious illness, such as cancer, autoimmune disease, progressive atherosclerotic disease or complications of diabetes, chronic obstructive pulmonary disease, need oxygen therapy for acute or progressive liver or kidney disease, congestive heart-failure etc. History of signs disease or symptoms of neurological symptoms Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome) Acute attacks of various acute or chronic diseases in the past 7 days Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases Congenital malformations or developmental disorders, genetic defects, severe malnutrition etc No spleen, functional absence of spleen, and splenectomy or splenectomy without any condition Autoimmune diseases or immunodeficiency have been treated with immunosuppressive agents in the past 6 months History of epilepsy, convulsions, or a family history of psychosis Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy The blood products were received within 3 months prior to the acceptance of the vaccine Received a live vaccine within 14 days prior to receiving the vaccine, or received a subunit or inactivated vaccine within 7 days Fever within 3 days prior to vaccination, axillary temperature ≥38 ℃ Being febrile When inoculating vaccine, axillary temperature >37.0 ℃ Women are pregnant or in the near future planned pregnancy or pregnancy test positive Participants in another clinical trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chen Ze, PhD

Phone

+86-021-62826658

chenze2005@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xia Shengli, PhD

Organizational Affiliation

Henan Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Suiping Center for Disease Control and Prevention

City

Zhumadian

State/Province

Henan

ZIP/Postal Code

463100

Country

China

12. IPD Sharing Statement

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A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine

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