Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine

Seqirus539 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

539

Conditions

Influenza, Human Flu, Human Flu, Avian Influenza Influenza A Virus, H5N1 Subtype

Interventions

Novartis Investigational H5N1 vaccineBIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Novartis Investigational H5N1 vaccineBIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Novartis Seasonal Influenza VaccineBIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (17)

102, Novartis Investigational Site

Darlinghurst, New South Wales, Australia

103, Novartis Investigational Site

Darlinghurst, New South Wales, Australia

Outcomes

Primary Outcomes

Percentage of subjects achieving seroconversion*

\*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.

Time frame: day 43

Geometric mean ratios (GMRs) as determined by HI assay

Time frame: day 43

Percentage of subjects with an HI titer ≥1:40

Time frame: day 43

Solicited and unsolicited adverse events

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.

Time frame: day 202

Secondary Outcomes

Geometric mean titers as determined by Hemagglutination Inhibition

Time frame: Day 1

Geometric mean titers as determined by Hemagglutination Inhibition

Time frame: Day 22

Geometric mean titers as determined by Hemagglutination Inhibition

Time frame: Day 43

Geometric mean titers as determined by Single Radial Hemolysis

Time frame: Day 1

Geometric mean titers as determined by Single Radial Hemolysis

Time frame: Day 22

Geometric mean titers as determined by Single Radial Hemolysis

Data from ClinicalTrials.gov

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