Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Underlying Medical Conditions

Phase 3CompletedNCT02091908

Seqirus540 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 underlying medical conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

540

Conditions

Influenza, Human

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 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.

Locations (6)

001, Novartis Investigational Site

Berlin, Germany

003, Novartis Investigational Site

Dresden, Germany

005, Novartis Investigational Site

Hamburg, Germany

006, Novartis Investigational Site

Magdeburg, Germany

Outcomes

Primary Outcomes

Percentage of subjects achieving seroconversion

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 \[day 1 HI titer ≥1:10\])

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 (GMTs) as determined by HI

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

Time frame: day 1

Geometric mean ratios (GMRs) as determined by SRH

Time frame: day 22

Percentage of subjects with an HI titer ≥1:40

Time frame: day 22

Percentage of subjects achieving seroconversion

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 \[SRH area \>3.997 mm2\])

Data from ClinicalTrials.gov

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2 doses of 0.5 ml, 3 weeks apart

004, Novartis Investigational Site

Rostock, Germany

002, Novartis Investigational Site

Würzburg, Germany

Percentage of subjects with geometric mean area ≥25 mm2

Time frame: day 43

Percentage of subjects achieving seroconversion

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 \[day 1 HI titer ≥1:10\])

Time frame: day 22

GMTs as determined by SRH

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

Time frame: day 43 (3 weeks after the second vaccination)

GMRs as determined by HI

Time frame: day 22

Geometric mean titers (GMTs) as determined by HI

Time frame: day 43 (3 weeks after the second vaccination)

Geometric mean titers (GMTs) as determined by HI

Time frame: day 22 (3 weeks after the first vaccination)

GMRs as determined by SRH

Time frame: day 43

Percentage of subjects with an HI titer ≥1:40

Time frame: day 1

Percentage of subjects with geometric mean area ≥25 mm2

Time frame: day 1

Percentage of subjects with geometric mean area ≥25 mm2

Time frame: day 22

Percentage of subjects achieving seroconversion

Time frame: day 43

GMTs as determined by SRH

Time frame: day 1

Geometric mean ratios (GMRs) as determined by SRH

Time frame: day 43 (3 weeks after the second vaccination)