A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine

NCT ID: NCT03755427

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-10
• Study Completion Date: 2019-11-15

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.

Conditions

H7N9 Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

15μg H7N9 Vaccine

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

Group Type: EXPERIMENTAL

15μg H7N9 Vaccine

Intervention Type: BIOLOGICAL

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

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.

Group Type: PLACEBO_COMPARATOR

Aluminum Hydroxide Adjuvant

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Institute Of Biological Products

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xia Shengli, PhD

Role: PRINCIPAL_INVESTIGATOR

Henan Center for Disease Control and Prevention

Locations

Suiping Center for Disease Control and Prevention

Zhumadian, Henan, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016L09902/3-2

Identifier Type: -

Identifier Source: org_study_id