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

This study has been completed.
Sponsor:
Information provided by:
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01201902
First received: September 13, 2010
Last updated: September 17, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Influenza Infection
Biological: Adjuvanted influenza A(H1N1) vaccine
Biological: un-adjuvanted influenza A(H1N1) vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • HI antibody responses after 1 and/or 2 vaccinations [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 592
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Split-virion vaccine
Experimental: Group 1: High dose with adjuvant
Group 1: 18 ~ 64 years old subjects
Biological: Adjuvanted influenza A(H1N1) vaccine
0.5ml, Intramuscular on Day 0 and 21
Other Name: 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 Name: 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 Name: 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
0.5ml, Intramuscular on Day 0 and 21
Other Name: Split-virion vaccine

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201902

Sponsors and Collaborators
Green Cross Corporation
Investigators
Principal Investigator: Woo-ju Kim Korea University Guro Hospital
  More Information

No publications provided

Responsible Party: Medical Team, Green Cross Corparation
ClinicalTrials.gov Identifier: NCT01201902     History of Changes
Other Study ID Numbers: GC1116, 임상제도과 - 649호(2009.9.28)
Study First Received: September 13, 2010
Last Updated: September 17, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014