A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine

NCT03755427 | Completed Phase 2 DMC

• 1 other identifier: 2016L09902/3-2
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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

Keywords

H7N9

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of participants that presented seroconversion post injection

  21 days after two inoculations

• Number of participants that presented seroprotection post injection

  21 days after two inoculations

• Geometric mean of Hemagglutination-inhibition titre post first study injection

  21 days after two inoculations

Study Arms (2)

15μg H7N9 Vaccine

EXPERIMENTAL

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

Biological: 15μg H7N9 Vaccine

Aluminum hydroxide adjuvant

PLACEBO COMPARATOR

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.

Biological: Aluminum Hydroxide Adjuvant

Interventions

15μg H7N9 Vaccine 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.

15μg H7N9 Vaccine

Aluminum Hydroxide Adjuvant 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.

Aluminum hydroxide adjuvant

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Suiping Center for Disease Control and Prevention

Zhumadian, Henan, 463100, China

Location

Study Officials

• Xia Shengli, PhD

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 28, 2018
• Study Start: November 10, 2018
• Primary Completion: January 5, 2019
• Study Completion: November 15, 2019
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

CN (1)