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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03755427
Other study ID # 2016L09902/3-2
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date November 2018
Est. completion date January 2020

Study information

Verified date November 2018
Source Shanghai Institute Of Biological Products
Contact Chen Ze, PhD
Phone +86-021-62826658
Email chenze2005@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 560
Est. completion date January 2020
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
15µg H7N9 Vaccine
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.
Aluminum Hydroxide Adjuvant
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.

Locations

Country Name City State
China Suiping Center for Disease Control and Prevention Zhumadian Henan

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Institute Of Biological Products

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Continuous observation for 30 days after two inoculations
Secondary 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
21 days after two inoculations
Secondary 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
21 days after two inoculations
Secondary 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.
21 days after two inoculations
See also
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Not yet recruiting NCT06417853 - Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) Phase 1
Active, not recruiting NCT03369808 - A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine Phase 1/Phase 2
Completed NCT01928472 - Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years Phase 1