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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01766921
Registration number
NCT01766921
Ethics application status
Date submitted
10/01/2013
Date registered
11/01/2013
Date last updated
30/01/2019
Titles & IDs
Public title
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects
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Scientific title
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.
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Secondary ID [1]
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V89_13
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pandemic H5N1 Influenza
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Adjuvanted H5N1 pandemic influenza vaccine
Experimental: aH5N1c - High dose -
Experimental: aH5N1c - Low dose -
Other interventions: Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers =40 Against A/H5N1 Strain.
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Assessment method [1]
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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%.
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Timepoint [1]
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Baseline (day 1) and Three weeks after 2nd vaccination (day 43)
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Primary outcome [2]
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The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
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Assessment method [2]
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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%.
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Timepoint [2]
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Three weeks after 2nd vaccination (day 43)
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Primary outcome [3]
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Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.
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Assessment method [3]
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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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Timepoint [3]
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From day 1 through day 7 after any vaccination.
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Primary outcome [4]
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Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
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Assessment method [4]
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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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Timepoint [4]
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Day 1 through day 387 after any vaccination
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Secondary outcome [1]
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Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.
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Assessment method [1]
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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.
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Timepoint [1]
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Day 1; day 22; day 43 and day 387
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Secondary outcome [2]
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Percentages Of Subjects With HI Titers =40 Against A/H5N1 Strain
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Assessment method [2]
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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%.
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Timepoint [2]
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Day 1, day 22, day 43 and day 387.
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Secondary outcome [3]
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The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain
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Assessment method [3]
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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%.
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Timepoint [3]
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Day 22, day 43 and day 387
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Eligibility
Key inclusion criteria
1. Healthy elderly subjects =65 years,
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.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Individuals not able to understand and follow study procedures,
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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2014
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Sample size
Target
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Accrual to date
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Final
1393
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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42 Hunter Clinical Research - Newcastle
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Recruitment hospital [2]
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44 Wesley Research Institute Clinical Trials Center - Auchenflower
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Recruitment hospital [3]
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40 CMAX - Adelaide
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Recruitment hospital [4]
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41 Linear Clinical Research - Nedlands
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Recruitment hospital [5]
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45 Childrens Clin Rsrch Facility - Perth
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Recruitment postcode(s) [1]
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2292 - Newcastle
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Recruitment postcode(s) [2]
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4066 - Auchenflower
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment postcode(s) [5]
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6872 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Kansas
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Country [4]
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United States of America
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State/province [4]
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Missouri
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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United States of America
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State/province [7]
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Utah
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Country [8]
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New Zealand
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State/province [8]
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Christchurch
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Country [9]
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Thailand
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State/province [9]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Vaccines
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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Department of Health and Human Services
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived
influenza vaccine in elderly subjects
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01766921
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis vaccines and Diagnostics
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Address
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Novartis Vaccines
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01766921
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