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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
2011-003573-28
Secondary ID [2] 0 0
V87_26
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza, Human 0 0
Flu, Human 0 0
Flu, Avian 0 0
Influenza 0 0
Influenza A Virus, H5N1 Subtype 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Novartis Investigational H5N1 vaccine
Other interventions - Novartis Investigational H5N1 vaccine
Other interventions - Novartis Seasonal Influenza Vaccine
Other interventions - 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


Other interventions: Novartis Investigational H5N1 vaccine
2 doses of 0.5 ml, 3 weeks apart

Other interventions: Novartis Investigational H5N1 vaccine
2 doses of 0.5 ml, 3 weeks apart

Other interventions: Novartis Seasonal Influenza Vaccine
2 doses of 0.5 ml, 3 weeks apart

Other interventions: Novartis Seasonal Influenza Vaccine
2 doses of 0.5 ml, 3 weeks apart

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of subjects achieving seroconversion* - *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.
Timepoint [1] 0 0
day 43
Primary outcome [2] 0 0
Geometric mean ratios (GMRs) as determined by HI assay
Timepoint [2] 0 0
day 43
Primary outcome [3] 0 0
Percentage of subjects with an HI titer =1:40
Timepoint [3] 0 0
day 43
Primary outcome [4] 0 0
Solicited and unsolicited adverse events - 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.
Timepoint [4] 0 0
day 202
Secondary outcome [1] 0 0
Geometric mean titers as determined by Hemagglutination Inhibition
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
Geometric mean titers as determined by Hemagglutination Inhibition
Timepoint [2] 0 0
Day 22
Secondary outcome [3] 0 0
Geometric mean titers as determined by Hemagglutination Inhibition
Timepoint [3] 0 0
Day 43
Secondary outcome [4] 0 0
Geometric mean titers as determined by Single Radial Hemolysis
Timepoint [4] 0 0
Day 1
Secondary outcome [5] 0 0
Geometric mean titers as determined by Single Radial Hemolysis
Timepoint [5] 0 0
Day 22
Secondary outcome [6] 0 0
Geometric mean titers as determined by Single Radial Hemolysis
Timepoint [6] 0 0
Day 43
Secondary outcome [7] 0 0
Geometric Mean Ratio as determined by Hemagglutination Inhibition
Timepoint [7] 0 0
Day 22
Secondary outcome [8] 0 0
Geometric Mean Ratio as determined by Hemagglutination Inhibition
Timepoint [8] 0 0
Day 43
Secondary outcome [9] 0 0
Geometric Mean Ratio as determined by Single Radial Hemolysis
Timepoint [9] 0 0
Day 22
Secondary outcome [10] 0 0
Geometric Mean Ratio as determined by Single Radial Hemolysis
Timepoint [10] 0 0
Day 43
Secondary outcome [11] 0 0
Percentage of subjects achieving seroconversion determined by HI - 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
Timepoint [11] 0 0
Day 22
Secondary outcome [12] 0 0
Percentage of subjects achieving seroconversion determined by SRH - 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
Timepoint [12] 0 0
Day 22
Secondary outcome [13] 0 0
Percentage of subjects achieving seroconversion determined by SRH - 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
Timepoint [13] 0 0
Day 43
Secondary outcome [14] 0 0
Percentage of subjects with an HI titer =1:40
Timepoint [14] 0 0
Day 1
Secondary outcome [15] 0 0
Percentage of subjects with an HI titer =1:40
Timepoint [15] 0 0
Day 22
Secondary outcome [16] 0 0
Percentage of subjects with geometric mean area =25 mm2
Timepoint [16] 0 0
Day 1
Secondary outcome [17] 0 0
Percentage of subjects with geometric mean area =25 mm2
Timepoint [17] 0 0
Day 22
Secondary outcome [18] 0 0
Percentage of subjects with geometric mean area =25 mm2
Timepoint [18] 0 0
Day 43

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
102, Novartis Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
103, Novartis Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
101, Novartis Investigational Site - Merewether
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Bayern
Country [2] 0 0
Germany
State/province [2] 0 0
Mecklenburg-Vorpommern
Country [3] 0 0
Germany
State/province [3] 0 0
Sachsen-Anhalt
Country [4] 0 0
Germany
State/province [4] 0 0
Hamburg
Country [5] 0 0
Italy
State/province [5] 0 0
Chieti
Country [6] 0 0
Italy
State/province [6] 0 0
Milan
Country [7] 0 0
Italy
State/province [7] 0 0
Padova
Country [8] 0 0
Italy
State/province [8] 0 0
Udine
Country [9] 0 0
Italy
State/province [9] 0 0
Parma

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Seqirus
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novartis Vaccines
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02107807
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.
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. 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].
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Vaccines
Address 0 0
Novartis Vaccines
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications