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 Adult Subjects.
Sponsor study identifier
interventional
979
3 countries
8
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
May 2014
Actual (reported)Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 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 20, 2013
Actual (reported)January 28, 2013
Actual (reported)June 2013
Actual (reported)May 2014
Actual (reported)February 3, 2015
Actual (reported)Percentages Of Subjects Achieving Hemagglutinin 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. CBER criterion for the adult 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 70%.
Three weeks after 2nd vaccination (day 43)
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 either a) in subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or b) in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. CBER criterion for the adult 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 40%.
Three weeks after 2nd vaccination (day 43)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination.
Safety was assessed using the number of subjects who reported solicited local and systemic AEs following vaccination with either low or high dose of aH5N1c vaccine.
From day 1 through day 7 after any vaccination.
Geometric Mean Ratios 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
Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
Day 22, day 43 and day 387
Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
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 Miami Research Associates
Miami, Florida, 33143, United States
2 Mercy Health Research
St Louis, Missouri, 63141, United States
3 Saint Louis University
St Louis, Missouri, 63141, United States
4 Benchmark Medical Research
Austin, Texas, 78705, United States
48 Hunter Clinical Research
Newcastle, New South Wales, 2292, Australia
46 CMAX
Adelaide, South Australia, 5000, Australia
47 Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
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
979 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2013
First Posted
January 28, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Number of Subjects Reporting Unsolicited AEs 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 either low or high dose of aH5N1c vaccine.
Any unsolicited AEs - day 1 through day 22 after any vaccination. SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387
Contact the study team to confirm eligibility.
80 Faculty of Tropical Medicine
Bangkok, 1040, Thailand
Primary Completion
June 2013
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
February 3, 2015
Results First Posted
February 3, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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