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.
Sponsor study identifier
interventional
1,393
4 countries
23
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Actual (reported)Study Completion
July 2014
Actual (reported)Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly subjects
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 10, 2013
Actual (reported)January 11, 2013
Actual (reported)July 2013
Actual (reported)July 2014
Actual (reported)August 10, 2015
Actual (reported)The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.
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)
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
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)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.
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.
From day 1 through day 7 after any vaccination.
Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.
Day 1; day 22; day 43 and day 387
Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain
Day 1, day 22, day 43 and day 387.
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain
Day 22, day 43 and day 387
Comparison of two doses of aH5N1c vaccine
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
1 Tatum Highlands Med Ass PLLC
Phoenix, Arizona, 85253, United States
5 Broward Research Group Pembroke Pines
Hollywood, Florida, 33024, United States
7 Heartland Rsrch Ass LLC
Wichita, Kansas, 67207, United States
9 Heartland Research Associates
Wichita, Kansas, 67207, United States
2 Mercy Health Research
St Louis, Missouri, 63141, United States
3 Saint Louis University
St Louis, Missouri, 63141, United States
6 Regional Clinical Research Endwell,
Endwell, New York, 13760, United States
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.
Novartis vaccines and Diagnostics
Novartis Vaccines
1,393 participants (actual enrollment reported by the registry).
First Submitted
January 10, 2013
First Posted
January 11, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
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
Day 1 through day 387 after any vaccination
Contact the study team to confirm eligibility.
4 Benchmark Medical Research
Austin, Texas, 78705, United States
12 Tekton Research
Georgetown, Texas, 78745, United States
8 J. Lewis Research Inc.
Salt Lake City, Utah, 84109, United States
10 Foothill Family Clinic
South Cottonwood Heights, Utah, 84121, United States
11 Jordan River Family Medicine
South Jordan, Utah, 84095, United States
42 Hunter Clinical Research
Newcastle, New South Wales, 2292, Australia
44 Wesley Research Institute Clinical Trials Center
Auchenflower, Queensland, 4066, Australia
40 CMAX
Adelaide, South Australia, 5000, Australia
41 Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
45 Childrens Clin Rsrch Facility
Perth, Western Australia, 6872, Australia
50 Southern Clinical Trials
Beckenham, Christchurch, 8244, New Zealand
51 Riccarton Clinic
Riccarton, Christchurch, 8041, New Zealand
72 Faculty of Medicine, Chulalongkorn University - Queen Saovabha Memorial Institute
Bangkok, 10330, Thailand
71 Phramongkutklao Hospital
Bangkok, 10400, Thailand
73 Siriraj Clinical Research Ctr
Bangkok, 10700, Thailand
74 Chiang Mai Uni Hospital Clinical Trial Center
Bangkok, 50200, Thailand
Primary Completion
July 2013
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
January 30, 2019
Results First Posted
August 10, 2015
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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