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CompletedNCT01201902Updated Sep 20, 2010

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

A Phase 3 interventional study of Adjuvanted influenza A(H1N1) vaccine and Adjuvanted influenza A(H1N1) vaccine in Influenza Infection, sponsored by Green Cross Corporation. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-09-20.

Sponsored by Green Cross Corporation · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
592
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)
02

Conditions studied

  • Influenza Infection

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 592 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Green Cross Corporation is the lead sponsor of 61 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
592 participants (actual)

Study arms

  • Experimental
    Group 1 : Low dose with adjuvant

    Group 1: 18 \~ 64 years old subjects

    Biological: Adjuvanted influenza A(H1N1) vaccine

  • Experimental
    Group 1: High dose with adjuvant

    Group 1: 18 \~ 64 years old subjects

    Biological: Adjuvanted influenza A(H1N1) vaccine

  • Active comparator
    Group1 : Plain vaccine

    Group 1: 18 \~ 64 years old subjects

    Biological: un-adjuvanted influenza A(H1N1) 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

  • Experimental
    Group 2 : high dose with adjuvant

    Group 2: greater than or equal to 65 years of age

    Biological: Adjuvanted influenza A(H1N1) vaccine

Interventions

  • BiologicalAdjuvanted influenza A(H1N1) vaccine

    0.25ml, Intramuscular on Day 0 and 21

    Also known as: Split-virion vaccine

  • BiologicalAdjuvanted influenza A(H1N1) vaccine

    0.5ml, Intramuscular on Day 0 and 21

    Also known as: Split-virion vaccine

  • Biologicalun-adjuvanted influenza A(H1N1) vaccine

    0.5ml, Intramuscular on Day 0 and 21

    Also known as: Split-virion vaccine

  • BiologicalAdjuvanted influenza A(H1N1) vaccine

    0.25ml, Intramuscular on Day 0 and 21

    Also known as: Split-virion vaccine

  • BiologicalAdjuvanted influenza A(H1N1) vaccine

    0.5ml, Intramuscular on Day 0 and 21

    Also known as: Split-virion vaccine

06

What researchers measure

Primary outcomes

  1. HI antibody responses after 1 and/or 2 vaccinations

    Time frame: 21 days after vaccination

Secondary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01201902
Lead sponsor
Green Cross Corporation
First posted
Sep 15, 2010
Start date
Oct 2009
Primary completion
Dec 2009
Completion
Jul 2010
Last update
Sep 20, 2010

Study contacts

Woo-ju Kim
principal investigator · Korea University Guro Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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