Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects
NCT ID: NCT01766921
Last Updated: 2019-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1393 participants
INTERVENTIONAL
2013-01-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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aH5N1c - High dose
Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
aH5N1c - Low dose
Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
Interventions
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Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
Eligibility Criteria
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Inclusion Criteria
2. Individuals willing to provide written informed consent,
3. Individuals in good health,
4. Individuals willing to allow for their serum samples to be stored beyond the study period.
Exclusion Criteria
2. History of any significant illness,
3. History of any serious chronic medical condition or progressive disease,
4. Presence of medically significant cancer,
5. Known or suspected impairment/alteration of immune function,
6. Presence of any progressive or severe neurologic disorder,
7. Presence of any bleeding disorders or conditions that prolongs bleeding time,
8. History of allergy to vaccine components,
9. Receipt of any other investigational product within 30 days prior to entry into the study,
10. History of previous H5N1 vaccination,
11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
12. Receipt of any other vaccine within 2 weeks prior to entry into the study
13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
14. Body mass index (BMI) ≥ 35 kg/m2,
15. History of drug or alcohol abuse,
16. Any planned surgery during study period,
17. Individuals conducting the study and their immediate family members,
18. Individuals with behavioral or cognitive impairment or psychiatric diseases.
65 Years
ALL
Yes
Sponsors
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Department of Health and Human Services
FED
Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis vaccines and Diagnostics
Role: STUDY_CHAIR
Novartis Vaccines
Locations
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1 Tatum Highlands Med Ass PLLC
Phoenix, Arizona, United States
5 Broward Research Group Pembroke Pines
Hollywood, Florida, United States
7 Heartland Rsrch Ass LLC
Wichita, Kansas, United States
9 Heartland Research Associates
Wichita, Kansas, United States
2 Mercy Health Research
St Louis, Missouri, United States
3 Saint Louis University
St Louis, Missouri, United States
6 Regional Clinical Research Endwell,
Endwell, New York, United States
4 Benchmark Medical Research
Austin, Texas, United States
12 Tekton Research
Georgetown, Texas, United States
8 J. Lewis Research Inc.
Salt Lake City, Utah, United States
10 Foothill Family Clinic
South Cottonwood Heights, Utah, United States
11 Jordan River Family Medicine
South Jordan, Utah, United States
42 Hunter Clinical Research
Newcastle, New South Wales, Australia
44 Wesley Research Institute Clinical Trials Center
Auchenflower, Queensland, Australia
40 CMAX
Adelaide, South Australia, Australia
41 Linear Clinical Research
Nedlands, Western Australia, Australia
45 Childrens Clin Rsrch Facility
Perth, Western Australia, Australia
50 Southern Clinical Trials
Beckenham, Christchurch, New Zealand
51 Riccarton Clinic
Riccarton, Christchurch, New Zealand
72 Faculty of Medicine, Chulalongkorn University - Queen Saovabha Memorial Institute
Bangkok, , Thailand
71 Phramongkutklao Hospital
Bangkok, , Thailand
73 Siriraj Clinical Research Ctr
Bangkok, , Thailand
74 Chiang Mai Uni Hospital Clinical Trial Center
Bangkok, , Thailand
Countries
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References
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Frey SE, Shakib S, Chanthavanich P, Richmond P, Smith T, Tantawichien T, Kittel C, Jaehnig P, Mojares Z, Verma B, Kanesa-Thasan N, Hohenboken M. Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly. Open Forum Infect Dis. 2019 Mar 1;6(4):ofz107. doi: 10.1093/ofid/ofz107. eCollection 2019 Apr.
Other Identifiers
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V89_13
Identifier Type: -
Identifier Source: org_study_id
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