Clinical trial NCT02091908: Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Underlying Medical Conditions
Official title: Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1 When Administered to Adult and Elderly Subjects With and Without Underlying Medical Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Keywords: Influenza
H5N1
aH5N1
H5N1 vaccine
Pandemic Influenza vaccine
MF59, Adjuvant, Avian flu
Underlying medical conditions
Underlying cardiovascular medical condition
Pandemic vaccine
Charlson Comorbidity Index (CCI)
Adjuvanted vaccine
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2014-03-19
Enrollment: 540
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 underlying medical 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 with underlying COPD, cardiovascular disease, diabetes mellitus, peripheral vascular disease, or renal impairment 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 (GMTs) as determined by HI
timeFrame: day 1
measure: Geometric mean ratios (GMRs) as determined by SRH
timeFrame: day 22
measure: Percentage of subjects with an HI titer ≥1:40
timeFrame: day 22
measure: Percentage of subjects achieving seroconversion
timeFrame: day 22
measure: Percentage of subjects with geometric mean area ≥25 mm2
timeFrame: day 43
measure: Percentage of subjects achieving seroconversion
timeFrame: day 22
measure: GMTs as determined by SRH
timeFrame: day 43 (3 weeks after the second vaccination)
measure: GMRs as determined by HI
timeFrame: day 22
measure: Geometric mean titers (GMTs) as determined by HI
timeFrame: day 43 (3 weeks after the second vaccination)
measure: Geometric mean titers (GMTs) as determined by HI
timeFrame: day 22 (3 weeks after the first vaccination)
measure: GMRs as determined by SRH
timeFrame: day 43
measure: Percentage of subjects with an HI titer ≥1:40
timeFrame: day 1
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 achieving seroconversion
timeFrame: day 43
measure: GMTs as determined by SRH
timeFrame: day 1
measure: Geometric mean ratios (GMRs) as determined by SRH
timeFrame: day 43 (3 weeks after the second vaccination)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 001, Novartis Investigational Site
city: Dresden
country: Germany
facility: 003, Novartis Investigational Site
city: Hamburg
country: Germany
facility: 005, Novartis Investigational Site
city: Magdeburg
country: Germany
facility: 006, Novartis Investigational Site
city: Rostock
country: Germany
facility: 004, Novartis Investigational Site
city: Wuerzburg
country: Germany
facility: 002, Novartis Investigational Site
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
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.
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.