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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
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.
Details
| Lead sponsor | Seqirus |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 539 |
| Start date | 2014-04 |
| Completion | 2015-05 |
Conditions
- Influenza, Human
- Flu, Human
- Flu, Avian
- Influenza
- Influenza A Virus, H5N1 Subtype
Interventions
- Novartis Investigational H5N1 vaccine
- Novartis Investigational H5N1 vaccine
- Novartis Seasonal Influenza Vaccine
- Novartis Seasonal Influenza Vaccine
Primary outcomes
- 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.
Countries
Australia, Germany, Italy