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

Phase 3

Completed

• Conditions: Influenza, Human
• Interventions: Biological: Novartis Seasonal Influenza Vaccine; Biological: Novartis Investigational H5N1 vaccine

• Registration Number: NCT02091908
• Lead Sponsor: Seqirus

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 underlying medical conditions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-19
• Study Start: 2014-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3: aTIV adult	Novartis Seasonal Influenza Vaccine	aTIV healthy and non-healthy adults
Arm 4: aTIV elderly	Novartis Seasonal Influenza Vaccine	aTIV healthy and non-healthy elderly
Arm 1: aH5N1 adult	Novartis Investigational H5N1 vaccine	aH5N1 healthy and non-healthy adults
Arm 2: aH5N1 elderly	Novartis Investigational H5N1 vaccine	aH5N1 healthy and non-healthy elderly

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with an HI titer ≥1:40	day 43
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
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 Outcome Measures

Name	Time	Method
GMTs as determined by SRH	day 1	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
Geometric mean titers (GMTs) as determined by HI	day 22 (3 weeks after the first vaccination)	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
Percentage of subjects with geometric mean area ≥25 mm2	day 22
Geometric mean ratios (GMRs) as determined by SRH	day 43 (3 weeks after the second vaccination)
Percentage of subjects with an HI titer ≥1:40	day 1
Percentage of subjects achieving seroconversion	day 43	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 \[SRH area \>3.997 mm2\])
GMRs as determined by SRH	day 43
GMRs as determined by HI	day 22

Trial Locations

Locations (6)

003, Novartis Investigational Site; 🇩🇪 Dresden, Germany

006, Novartis Investigational Site; 🇩🇪 Magdeburg, Germany

005, Novartis Investigational Site; 🇩🇪 Hamburg, Germany

004, Novartis Investigational Site; 🇩🇪 Rostock, Germany

002, Novartis Investigational Site; 🇩🇪 Wuerzburg, Germany

001, Novartis Investigational Site; 🇩🇪 Berlin, Germany