Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children
NCT ID: NCT01776554
Last Updated: 2019-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
662 participants
INTERVENTIONAL
2013-01-31
2014-06-30
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
SINGLE
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' parent(s) or legal guardian(s) willing to provide written informed consent,
3. Individuals in good health,
4. Individuals/Individuals' parent(s)/legal guardian(s) willing to allow for serum samples to be stored beyond the study period,
5. Individuals willing to provide informed assent (where applicable).
Exclusion Criteria
2. History of any significant illness,
3. History of any 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 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
14. Pregnant or breast feeding,
15. Females of childbearing potential refusing to use acceptable method of birth control,
16. Body mass index (BMI) ≥ 35 kg/m2,
17. History of drug or alcohol abuse,
18. Any planned surgery during study period,
19. Individuals conducting the study and their immediate family members,
20. Individuals with behavioral or cognitive impairment or psychiatric diseases,
21. Individuals diagnosed with any growth disorders.
6 Months
17 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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3 Meridian Clinical Research
Miami, Florida, United States
7 Heartland Research Associates
Newton, Kansas, United States
5 Heartland Research Associates
Wichita, Kansas, United States
9 Heartland Research Associates
Wichita, Kansas, United States
1 Saint Louis University
St Louis, Missouri, United States
6 Meridian Clinical Research
Omaha, Nebraska, United States
10 Tekton Research
Georgetown, Texas, United States
8 Foothill Family Clinic
Salt Lake City, Utah, United States
4 Foothill Family Clinic
South Cottonwood Heights, Utah, United States
2 Rockwood Clinic P S
Spokane, Washington, United States
75 Phramongkutklao Hospital
Bangkok, , Thailand
76 Faculty of Tropical Medicine Mahidol University
Bangkok, , Thailand
Countries
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References
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Chanthavanich P, Versage E, Van Twuijver E, Hohenboken M. Antibody responses against heterologous A/H5N1 strains for an MF59-adjuvanted cell culture-derived A/H5N1 (aH5N1c) influenza vaccine in healthy pediatric subjects. Vaccine. 2021 Nov 16;39(47):6930-6935. doi: 10.1016/j.vaccine.2021.10.010. Epub 2021 Oct 25.
Chanthavanich P, Anderson E, Kerdpanich P, Bulitta M, Kanesa-Thasan N, Hohenboken M. Safety, Tolerability and Immunogenicity of an MF59-adjuvanted, Cell Culture-derived, A/H5N1, Subunit Influenza Virus Vaccine: Results From a Dose-finding Clinical Trial in Healthy Pediatric Subjects. Pediatr Infect Dis J. 2019 Jul;38(7):757-764. doi: 10.1097/INF.0000000000002345.
Other Identifiers
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V89_11
Identifier Type: -
Identifier Source: org_study_id
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