A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine

Phase 3

Completed

• Conditions: Influenza Infection
• Interventions: Biological: Adjuvanted influenza A(H1N1) vaccine; Biological: un-adjuvanted influenza A(H1N1) vaccine

• Registration Number: NCT01201902
• Lead Sponsor: Green Cross Corporation

Brief Summary

The purpose of this study is to assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than or equal to 65 years of age.

Detailed Description

▶ Immunogenicity(Efficacy) Outcome Measures : Hemagglutination inhibition assay

1. Proportion of subjects, stratified by group, with seroconversion to HI antibody

2. Proportion of subjects, stratified by group, achieving a serum hemagglutination inhibition assay(HIA) antibody titer of 1:40 greater against the influenza H1N1 2009 virus

3. GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) measuring by HIA antibody titer

* Safety Outcome Measures :

1. Solicited adverse events(Day 0 \~ 6, Day 21 \~ 27) 2. Unsolicited adverse events(Day 0 \~ 42) 3. Adverse events(Day 21 \~ 6 months)

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-12
• Study Completion: 2010-07
• Status Verified: 2010-09
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-15
• Last Update Submitted: 2010-09-17
• Last Update Posted: 2010-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

Inclusion Criteria

• Healthy adults age 18 and older.
• Are able to understand and comply with planned study procedures.
• Provide written informed consent prior to initiation of any study procedures.

Exclusion Criteria

• Have a known allergy to eggs, chickens or other components of the vaccine(including MF59).
• Have immunosuppression including immunodeficiency disease.
• Have a history of Guillain-Barre Syndrome.
• Have a diagnosis of thrombocytopenia.
• Have a chronic disease that the investigator believes may interfere with successful completion of the study. (Excluding regulating hypertension)
• Hemophilia Patients or Are receiving anti-coagulating agents. Low-dose aspirin (100mg/day) purpose of prevention is allowed.
• Are receiving anti-viral agents.
• Have an acute fever, a temperature greater than 38℃(100.4 degrees Fahrenheit) within 72 hours of vaccination or Have a symptom of acute febrile illness within 14 days prior to vaccination in this study.
• Received below agents or expect to receive agents within following periods. A. Have immunosuppression therapy, radiotherapy, use of high-dose glucocorticoids or prednisolone(≥15mg/day) within 6 months prior to vaccination in this study.Inhaled, nasal and topical steroids are allowed) B. Have a history of receiving immunoglobulin or other blood product within 3 months prior to vaccination in this study.

C. Received an experimental agent within 1 month prior to vaccination in this study.

D. Received any vaccines(live licensed and inactivated licensed) within 1 month prior to vaccination in this study. (Excluding seasonal Influenza vaccine)

• Those who are not eligible to receive vaccine injection in the arm deltoid muscle.
• Pregnant females, Nursing mom, Those women who have a chance to become pregnant, but not taking a proper contraception.
• Not agree to abstain from drinking following 7 days of vaccination.
• Have any condition (clinically regardful medical or psychological condition) that would, in the opinion of the site investigator, render them unable to meet the requirements of the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 : Low dose with adjuvant	Adjuvanted influenza A(H1N1) vaccine	Group 1: 18 \~ 64 years old subjects
Group 1: High dose with adjuvant	Adjuvanted influenza A(H1N1) vaccine	Group 1: 18 \~ 64 years old subjects
Group1 : Plain vaccine	un-adjuvanted influenza A(H1N1) vaccine	Group 1: 18 \~ 64 years old subjects
Group 2 : Low dose with adjuvant	Adjuvanted influenza A(H1N1) vaccine	Group 2: greater than or equal to 65 years of age
Group 2 : high dose with adjuvant	Adjuvanted influenza A(H1N1) vaccine	Group 2: greater than or equal to 65 years of age

Primary Outcome Measures

Name	Time	Method
HI antibody responses after 1 and/or 2 vaccinations	21 days after vaccination

Secondary Outcome Measures

Name	Time	Method
Solicited local & general AE, Unsolicited AE, AE until 6 months after last vaccination	the date of vaccination until 6 days after vaccination, 42days after first vaccination, 6 months after last vaccination