Flu, Avian, Flu, Human, Influenza, Influenza A Virus, H5N1 Subtype, Influenza, Human
Conditions
Keywords
Influenza,, H5N1, aH5N1, H5N1 vaccine, Pandemic Influenza vaccine, MF59, Adjuvant, Avian flu, Underlying Immunosuppressive, immunosuppressive conditions, Pandemic vaccine, 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 immunosuppressive 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects achieving seroconversion* | day 43 | \*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. |
| 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 |
|---|---|---|
| Percentage of subjects with an HI titer ≥1:40 | Day 1 | — |
| Geometric mean titers as determined by Hemagglutination Inhibition | Day 1 | — |
| Geometric Mean Ratio as determined by Hemagglutination Inhibition | Day 22 | — |
| Percentage of subjects with geometric mean area ≥25 mm2 | Day 1 | — |
| Geometric mean titers as determined by Single Radial Hemolysis | Day 1 | — |
| Geometric Mean Ratio as determined by Single Radial Hemolysis | Day 22 | — |
| Percentage of subjects achieving seroconversion determined by HI | Day 22 | 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 |
| Percentage of subjects achieving seroconversion determined by SRH | Day 22 | 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 |
Countries
Australia, Germany, Italy
Outcome results
None listed