- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01766921
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects
A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Elderly Subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New South Wales
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Newcastle, New South Wales, Australia, 2292
- 42 Hunter Clinical Research
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Queensland
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Auchenflower, Queensland, Australia, 4066
- 44 Wesley Research Institute Clinical Trials Center
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South Australia
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Adelaide, South Australia, Australia, 5000
- 40 CMAX
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- 41 Linear Clinical Research
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Perth, Western Australia, Australia, 6872
- 45 Childrens Clin Rsrch Facility
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Christchurch
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Beckenham, Christchurch, New Zealand, 8244
- 50 Southern Clinical Trials
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Riccarton, Christchurch, New Zealand, 8041
- 51 Riccarton Clinic
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Bangkok, Thailand, 10330
- 72 Faculty of Medicine, Chulalongkorn University - Queen Saovabha Memorial Institute
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Bangkok, Thailand, 10400
- 71 Phramongkutklao Hospital
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Bangkok, Thailand, 10700
- 73 Siriraj Clinical Research Ctr
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Bangkok, Thailand, 50200
- 74 Chiang Mai Uni Hospital Clinical Trial Center
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Arizona
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Phoenix, Arizona, United States, 85253
- 1 Tatum Highlands Med Ass PLLC
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Florida
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Hollywood, Florida, United States, 33024
- 5 Broward Research Group Pembroke Pines
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Kansas
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Wichita, Kansas, United States, 67207
- 7 Heartland Rsrch Ass LLC
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Wichita, Kansas, United States, 67207
- 9 Heartland Research Associates
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Missouri
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Saint Louis, Missouri, United States, 63141
- 2 Mercy Health Research
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Saint Louis, Missouri, United States, 63141
- 3 Saint Louis University
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New York
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Endwell, New York, United States, 13760
- 6 Regional Clinical Research Endwell,
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Texas
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Austin, Texas, United States, 78705
- 4 Benchmark Medical Research
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Georgetown, Texas, United States, 78745
- 12 Tekton Research
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Utah
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Salt Lake City, Utah, United States, 84109
- 8 J. Lewis Research Inc.
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South Cottonwood Heights, Utah, United States, 84121
- 10 Foothill Family Clinic
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South Jordan, Utah, United States, 84095
- 11 Jordan River Family Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy elderly subjects ≥65 years,
- Individuals willing to provide written informed consent,
- Individuals in good health,
- Individuals willing to allow for their serum samples to be stored beyond the study period.
Exclusion Criteria:
- Individuals not able to understand and follow study procedures,
- History of any significant illness,
- History of any serious chronic medical condition or progressive disease,
- Presence of medically significant cancer,
- Known or suspected impairment/alteration of immune function,
- Presence of any progressive or severe neurologic disorder,
- Presence of any bleeding disorders or conditions that prolongs bleeding time,
- History of allergy to vaccine components,
- Receipt of any other investigational product within 30 days prior to entry into the study,
- History of previous H5N1 vaccination,
- Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
- Receipt of any other vaccine within 2 weeks prior to entry into the study
- Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
- Body mass index (BMI) ≥ 35 kg/m2,
- History of drug or alcohol abuse,
- Any planned surgery during study period,
- Individuals conducting the study and their immediate family members,
- Individuals with behavioral or cognitive impairment or psychiatric diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: aH5N1c - High dose
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Comparison of two doses of aH5N1c vaccine
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Experimental: aH5N1c - Low dose
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Comparison of two doses of aH5N1c vaccine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.
Time Frame: Baseline (day 1) and Three weeks after 2nd vaccination (day 43)
|
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%. |
Baseline (day 1) and Three weeks after 2nd vaccination (day 43)
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The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
Time Frame: Three weeks after 2nd vaccination (day 43)
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Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%. |
Three weeks after 2nd vaccination (day 43)
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Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.
Time Frame: From day 1 through day 7 after any vaccination.
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Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.
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From day 1 through day 7 after any vaccination.
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Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Time Frame: Day 1 through day 387 after any vaccination
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Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine
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Day 1 through day 387 after any vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.
Time Frame: Day 1; day 22; day 43 and day 387
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Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported. The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age. |
Day 1; day 22; day 43 and day 387
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Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain
Time Frame: Day 1, day 22, day 43 and day 387.
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Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion. The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%. |
Day 1, day 22, day 43 and day 387.
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The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain
Time Frame: Day 22, day 43 and day 387
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Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%. |
Day 22, day 43 and day 387
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V89_13
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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