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

September 17, 2010 updated by: Green Cross Corporation

Randomized, Open, Clinical Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine GC1116 With Adjuvant in Healthy Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

592

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1 : Low dose with adjuvant
Group 1: 18 ~ 64 years old subjects
Biological: Adjuvanted influenza A(H1N1) vaccine
0.25ml, Intramuscular on Day 0 and 21
Other Names:
  • Split-virion vaccine
Biological: Adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Other Names:
  • Split-virion vaccine
EXPERIMENTAL: Group 1: High dose with adjuvant
Group 1: 18 ~ 64 years old subjects
Biological: Adjuvanted influenza A(H1N1) vaccine
0.25ml, Intramuscular on Day 0 and 21
Other Names:
  • Split-virion vaccine
Biological: Adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Other Names:
  • Split-virion vaccine
ACTIVE_COMPARATOR: Group1 : Plain vaccine
Group 1: 18 ~ 64 years old subjects
Biological: un-adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Other Names:
  • Split-virion vaccine
EXPERIMENTAL: Group 2 : Low dose with adjuvant
Group 2: greater than or equal to 65 years of age
Biological: Adjuvanted influenza A(H1N1) vaccine
0.25ml, Intramuscular on Day 0 and 21
Other Names:
  • Split-virion vaccine
Biological: Adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Other Names:
  • Split-virion vaccine
EXPERIMENTAL: Group 2 : high dose with adjuvant
Group 2: greater than or equal to 65 years of age
Biological: Adjuvanted influenza A(H1N1) vaccine
0.25ml, Intramuscular on Day 0 and 21
Other Names:
  • Split-virion vaccine
Biological: Adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Other Names:
  • Split-virion vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HI antibody responses after 1 and/or 2 vaccinations
Time Frame: 21 days after vaccination
21 days after vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Solicited local & general AE, Unsolicited AE, AE until 6 months after last vaccination
Time Frame: the date of vaccination until 6 days after vaccination, 42days after first vaccination, 6 months after last vaccination
the date of vaccination until 6 days after vaccination, 42days after first vaccination, 6 months after last vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Investigators

  • Principal Investigator: Woo-ju Kim, Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (ESTIMATE)

September 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2010

Last Update Submitted That Met QC Criteria

September 17, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC1116
  • 임상제도과 - 649호(2009.9.28) (REGISTRY: Korea Food & Drug Administraion)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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