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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02107807
Registration number
NCT02107807
Ethics application status
Date submitted
7/03/2014
Date registered
8/04/2014
Date last updated
9/05/2016
Titles & IDs
Public title
Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine
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Scientific title
A Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1when Administered to Adult and Elderly Subjects With and Without Immunosuppressive Conditions
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Secondary ID [1]
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2011-003573-28
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Secondary ID [2]
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V87_26
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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:
Influenza, Human
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Flu, Human
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Flu, Avian
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Influenza
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Influenza A Virus, H5N1 Subtype
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Novartis Investigational H5N1 vaccine
Treatment: Other - Novartis Investigational H5N1 vaccine
Treatment: Other - Novartis Seasonal Influenza Vaccine
Treatment: Other - Novartis Seasonal Influenza Vaccine
Experimental: Arm 1: aH5N1 adult - aH5N1 healthy and non-healthy adults
Experimental: Arm 2: aH5N1 elderly - aH5N1 healthy and non-healthy elderly
Active comparator: Arm 4: aTIV elderly - aTIV healthy and non-healthy elderly
Active comparator: Arm 3: aTIV adult - aTIV healthy and non-healthy adults
Treatment: Other: Novartis Investigational H5N1 vaccine
2 doses of 0.5 ml, 3 weeks apart
Treatment: Other: Novartis Investigational H5N1 vaccine
2 doses of 0.5 ml, 3 weeks apart
Treatment: Other: Novartis Seasonal Influenza Vaccine
2 doses of 0.5 ml, 3 weeks apart
Treatment: Other: Novartis Seasonal Influenza Vaccine
2 doses of 0.5 ml, 3 weeks apart
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Intervention code [1]
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Treatment: Other
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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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Percentage of subjects achieving seroconversion*
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Assessment method [1]
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\*seroconversion: (defined as HI =1:40 for subjects who were seronegative at baseline \[day 1 HI titer \<1:10\] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline \[day 1 HI titer
=1:10\]) on day 43.
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Timepoint [1]
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day 43
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Primary outcome [2]
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Geometric mean ratios (GMRs) as determined by HI assay
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Assessment method [2]
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Timepoint [2]
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day 43
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Primary outcome [3]
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Percentage of subjects with an HI titer =1:40
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Assessment method [3]
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Timepoint [3]
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day 43
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Primary outcome [4]
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Solicited and unsolicited adverse events
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Assessment method [4]
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In pooled age groups 18 years of age and older subjects who are healthy or with underlying medical condition who have received aTIV or aH5N1 vaccine.
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Timepoint [4]
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day 202
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Secondary outcome [1]
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Geometric mean titers as determined by Hemagglutination Inhibition
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Assessment method [1]
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Timepoint [1]
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Day 1
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Secondary outcome [2]
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Geometric mean titers as determined by Hemagglutination Inhibition
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Assessment method [2]
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Timepoint [2]
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Day 22
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Secondary outcome [3]
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Geometric mean titers as determined by Hemagglutination Inhibition
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Assessment method [3]
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Timepoint [3]
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Day 43
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Secondary outcome [4]
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Geometric mean titers as determined by Single Radial Hemolysis
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Assessment method [4]
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Timepoint [4]
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Day 1
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Secondary outcome [5]
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Geometric mean titers as determined by Single Radial Hemolysis
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Assessment method [5]
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0
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Timepoint [5]
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Day 22
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Secondary outcome [6]
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Geometric mean titers as determined by Single Radial Hemolysis
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Assessment method [6]
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0
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Timepoint [6]
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Day 43
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Secondary outcome [7]
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Geometric Mean Ratio as determined by Hemagglutination Inhibition
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Assessment method [7]
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Timepoint [7]
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Day 22
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Secondary outcome [8]
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Geometric Mean Ratio as determined by Hemagglutination Inhibition
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Assessment method [8]
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0
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Timepoint [8]
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Day 43
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Secondary outcome [9]
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Geometric Mean Ratio as determined by Single Radial Hemolysis
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Assessment method [9]
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0
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Timepoint [9]
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Day 22
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Secondary outcome [10]
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Geometric Mean Ratio as determined by Single Radial Hemolysis
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Assessment method [10]
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0
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Timepoint [10]
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Day 43
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Secondary outcome [11]
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Percentage of subjects achieving seroconversion determined by HI
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Assessment method [11]
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seroconversion is defined as HI =1:40 for subjects who were seronegative at baseline \[day 1 HI titer \<1:10\] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline \[day 1 HI titer =1:10\]) on days 22
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Timepoint [11]
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Day 22
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Secondary outcome [12]
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Percentage of subjects achieving seroconversion determined by SRH
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Assessment method [12]
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seroconversion (defined as SRH area =25 mm2 for subjects who were seronegative at baseline \[day 1 SRH area =3.997 mm2\] or a significant increase \[at least 50% increase\] in SRH area for subjects who were seropositive at baseline \[SRH area \>3.997 mm2\]) on days 22, 43
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Timepoint [12]
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Day 22
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Secondary outcome [13]
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Percentage of subjects achieving seroconversion determined by SRH
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Assessment method [13]
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seroconversion is defined as SRH area =25 mm2 for subjects who were seronegative at baseline \[day 1 SRH area =3.997 mm2\] or a significant increase \[at least 50% increase\] in SRH area for subjects who were seropositive at baseline \[SRH area \>3.997 mm2\]) on days 22, 43
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Timepoint [13]
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Day 43
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Secondary outcome [14]
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Percentage of subjects with an HI titer =1:40
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Assessment method [14]
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Timepoint [14]
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Day 1
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Secondary outcome [15]
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Percentage of subjects with an HI titer =1:40
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Assessment method [15]
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Timepoint [15]
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Day 22
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Secondary outcome [16]
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Percentage of subjects with geometric mean area =25 mm2
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Assessment method [16]
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Timepoint [16]
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Day 1
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Secondary outcome [17]
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Percentage of subjects with geometric mean area =25 mm2
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Assessment method [17]
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Timepoint [17]
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Day 22
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Secondary outcome [18]
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Percentage of subjects with geometric mean area =25 mm2
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Assessment method [18]
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Timepoint [18]
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Day 43
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Eligibility
Key inclusion criteria
* Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry;
* Individuals who are able to comply with all study procedures and requirements;
* Healthy volunteers and volunteers specifically HIV positive, transplant recipients, cancer patients may be eligible;
* Please contact the site for additional eligibility criteria.
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Minimum age
18
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
* Individuals who are not able to follow all the required study procedures for the whole period of the study;
* Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study;
* Please contact the site for additional eligibility criteria.
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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 3
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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
1/04/2014
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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
1/05/2015
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Sample size
Target
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Accrual to date
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Final
539
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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102, Novartis Investigational Site - Darlinghurst
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Recruitment hospital [2]
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103, Novartis Investigational Site - Darlinghurst
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Recruitment hospital [3]
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101, Novartis Investigational Site - Merewether
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2291 - Merewether
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Bayern
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Country [2]
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Germany
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State/province [2]
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Mecklenburg-Vorpommern
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Country [3]
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Germany
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State/province [3]
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Sachsen-Anhalt
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Country [4]
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Germany
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State/province [4]
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Hamburg
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Country [5]
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Italy
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State/province [5]
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Chieti
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Country [6]
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Italy
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State/province [6]
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Milan
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Country [7]
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Italy
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State/province [7]
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Padova
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Country [8]
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Italy
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State/province [8]
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Udine
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Country [9]
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Italy
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State/province [9]
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Parma
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seqirus
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Novartis Vaccines
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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 the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (=61 years of age) subjects with and without immunosuppressive conditions.
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Trial website
https://clinicaltrials.gov/study/NCT02107807
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Trial related presentations / publications
Podda A. The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine. Vaccine. 2001 Mar 21;19(17-19):2673-80. doi: 10.1016/s0264-410x(00)00499-0. Atmar RL, Keitel WA, Patel SM, Katz JM, She D, El Sahly H, Pompey J, Cate TR, Couch RB. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza A/H9N2 vaccine preparations. Clin Infect Dis. 2006 Nov 1;43(9):1135-42. doi: 10.1086/508174. Epub 2006 Sep 25. Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, Capecchi PL, di Giovanni P, Sticchi L, Gentile C, Hilbert A, Brauer V, Tilman S, Podda A. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One. 2009;4(2):e4384. doi: 10.1371/journal.pone.0004384. Epub 2009 Feb 6. Erratum In: PLoS ONE. 2009;4(3). doi: 10.1371/annotation/5f2ae0fb-53f1-48c2-aa19-9114765ba029. Capecchi, Pamela [corrected to Capecchi, Pier Leopoldo].
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Public notes
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Contacts
Principal investigator
Name
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Novartis Vaccines
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02107807
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