Clinical trial NCT03755427: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: H7N9 Influenza
Keywords: H7N9
Lead sponsor: Shanghai Institute Of Biological Products
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 560
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
timeFrame: Continuous observation for 30 days after two inoculations
Secondary outcomes:
measure: Number of participants that presented seroconversion post injection
timeFrame: 21 days after two inoculations
measure: Number of participants that presented seroprotection post injection
timeFrame: 21 days after two inoculations
measure: Geometric mean of Hemagglutination-inhibition titre post first study injection
timeFrame: 21 days after two inoculations
Other outcomes:
Locations:
city: Zhumadian
country: China
facility: Suiping Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Center for Disease Control and Prevention
name: Xia Shengli, PhD
role: PRINCIPAL_INVESTIGATOR
References: