Clinical trial NCT02107807: Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Flu, Human
Flu, Avian
Influenza
Influenza A Virus, H5N1 Subtype
Keywords: Influenza,
H5N1
aH5N1
H5N1 vaccine
Pandemic Influenza vaccine
MF59
Adjuvant
Avian flu
Underlying Immunosuppressive
immunosuppressive conditions
Pandemic vaccine
Adjuvanted vaccine
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2014-04-08
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Percentage of subjects achieving seroconversion*
timeFrame: day 43
measure: Geometric mean ratios (GMRs) as determined by HI assay
timeFrame: day 43
measure: Percentage of subjects with an HI titer ≥1:40
timeFrame: day 43
measure: Solicited and unsolicited adverse events
timeFrame: day 202
Secondary outcomes:
measure: Geometric mean titers as determined by Hemagglutination Inhibition
timeFrame: Day 1
measure: Geometric mean titers as determined by Hemagglutination Inhibition
timeFrame: Day 22
measure: Geometric mean titers as determined by Hemagglutination Inhibition
timeFrame: Day 43
measure: Geometric mean titers as determined by Single Radial Hemolysis
timeFrame: Day 1
measure: Geometric mean titers as determined by Single Radial Hemolysis
timeFrame: Day 22
measure: Geometric mean titers as determined by Single Radial Hemolysis
timeFrame: Day 43
measure: Geometric Mean Ratio as determined by Hemagglutination Inhibition
timeFrame: Day 22
measure: Geometric Mean Ratio as determined by Hemagglutination Inhibition
timeFrame: Day 43
measure: Geometric Mean Ratio as determined by Single Radial Hemolysis
timeFrame: Day 22
measure: Geometric Mean Ratio as determined by Single Radial Hemolysis
timeFrame: Day 43
measure: Percentage of subjects achieving seroconversion determined by HI
timeFrame: Day 22
measure: Percentage of subjects achieving seroconversion determined by SRH
timeFrame: Day 22
measure: Percentage of subjects achieving seroconversion determined by SRH
timeFrame: Day 43
measure: Percentage of subjects with an HI titer ≥1:40
timeFrame: Day 1
measure: Percentage of subjects with an HI titer ≥1:40
timeFrame: Day 22
measure: Percentage of subjects with geometric mean area ≥25 mm2
timeFrame: Day 1
measure: Percentage of subjects with geometric mean area ≥25 mm2
timeFrame: Day 22
measure: Percentage of subjects with geometric mean area ≥25 mm2
timeFrame: Day 43
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: 102, Novartis Investigational Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: 103, Novartis Investigational Site
state: New South Wales
city: Merewether
country: Australia
facility: 101, Novartis Investigational Site
state: New South Wales
city: Würzburg
country: Germany
facility: 303, Novartis Investiagtional Site
state: Bayern
city: Rostock
country: Germany
facility: 304, Novartis Investigational Site
state: Mecklenburg-Vorpommern
city: Magdeburg
country: Germany
facility: 301, Novartis Investigational Site
state: Sachsen-Anhalt
city: Hamburg
country: Germany
facility: 302, Novartis Investigational Site
city: Fossacesia
country: Italy
facility: 082, Novartis Investigational Site
state: Chieti
city: Lanciano
country: Italy
facility: 081, Novartis Investigational Site
state: Chieti
city: Monza
country: Italy
facility: 003, Novartis Investigational Site
state: Milan
city: Aviano
country: Italy
facility: 007, Novartis Investigational Site
state: Padova
city: San Daniele del Friuli
country: Italy
facility: 006, Novartis Investigational Site
state: Udine
city: Chieti
country: Italy
facility: 005, Novartis Investigational Site
city: Chieti
country: Italy
facility: 008, Novartis Investigational Site
city: Milan
country: Italy
facility: 001, Novartis Investigational Site
city: Milan
country: Italy
facility: 002, Novartis Investigational Site
city: Parma
country: Italy
facility: 004, Novartis Investigational Site
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.