Influenza, Human
Conditions
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
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.
Interventions
BIOLOGICALNovartis Investigational H5N1 vaccine
2 doses of 0.5 ml, 3 weeks apart
BIOLOGICALNovartis Seasonal Influenza Vaccine
2 doses of 0.5 ml, 3 weeks apart
Sponsors
Novartis Vaccines
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects achieving seroconversion | day 43 | Seroconversion is defined as hemagglutination inhibition (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 \[day 1 HI titer ≥1:10\]) |
| Geometric mean ratios (GMRs) as determined by HI assay | day 43 | — |
| Percentage of subjects with an HI titer ≥1:40 | day 43 | — |
| Solicited and unsolicited adverse events | day 202 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean titers (GMTs) as determined by HI | day 1 | HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition |
| Geometric mean ratios (GMRs) as determined by SRH | day 22 | — |
| Percentage of subjects with an HI titer ≥1:40 | day 22 | — |
| Percentage of subjects achieving seroconversion | day 22 | 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 \[SRH area \>3.997 mm2\]) |
| Percentage of subjects with geometric mean area ≥25 mm2 | day 43 | — |
| GMTs as determined by SRH | day 43 (3 weeks after the second vaccination) | Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition |
| GMRs as determined by HI | day 22 | — |
| GMRs as determined by SRH | day 43 | — |
Countries
Germany
Outcome results
None listed