A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine
This study has been completed.
Sponsor:
Green Cross Corporation
Information provided by:
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01201902
First received: September 13, 2010
Last updated: September 17, 2010
Last verified: September 2010
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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
- Proportion of subjects, stratified by group, with seroconversion to HI antibody
- 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
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 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 May 23, 2013