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.

NCT02091908 Phase 3 COMPLETED

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.

Details

Lead sponsor	Seqirus
Phase	Phase 3
Status	COMPLETED
Enrolment	540
Start date	2014-04
Completion	2015-04

Conditions

• Influenza, Human

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 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.

Countries

Germany