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

Phase 3

Completed

• Conditions: Influenza A Virus, H5N1 Subtype; Flu, Human; Influenza, Human; Flu, Avian; Influenza
• Interventions: Biological: Novartis Investigational H5N1 vaccine; Biological: Novartis Seasonal Influenza Vaccine

• Registration Number: NCT02107807
• 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 immunosuppressive conditions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-07
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 539

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Geometric mean titers as determined by Hemagglutination Inhibition	Day 43
Geometric mean titers as determined by Single Radial Hemolysis	Day 43
Geometric Mean Ratio as determined by Hemagglutination Inhibition	Day 43
Geometric Mean Ratio as determined by Single Radial Hemolysis	Day 43
Percentage of subjects achieving seroconversion determined by HI	Day 22	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 \[day 1 HI titer ≥1:10\]) on days 22
Percentage of subjects achieving seroconversion determined by SRH	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 \[SRH area \>3.997 mm2\]) on days 22, 43
Percentage of subjects with an HI titer ≥1:40	Day 22
Percentage of subjects with geometric mean area ≥25 mm2	Day 43

Trial Locations

Locations (17)

304, Novartis Investigational Site; 🇩🇪 Rostock, Mecklenburg-Vorpommern, Germany

006, Novartis Investigational Site; 🇮🇹 San Daniele del Friuli, Udine, Italy

082, Novartis Investigational Site; 🇮🇹 Fossacesia, Chieti, Italy

081, Novartis Investigational Site; 🇮🇹 Lanciano, Chieti, Italy

008, Novartis Investigational Site; 🇮🇹 Chieti, Italy

003, Novartis Investigational Site; 🇮🇹 Monza, Milan, Italy

102, Novartis Investigational Site; 🇦🇺 Darlinghurst, New South Wales, Australia

005, Novartis Investigational Site; 🇮🇹 Chieti, Italy

103, Novartis Investigational Site; 🇦🇺 Darlinghurst, New South Wales, Australia

004, Novartis Investigational Site; 🇮🇹 Parma, Italy

007, Novartis Investigational Site; 🇮🇹 Aviano, Padova, Italy

001, Novartis Investigational Site; 🇮🇹 Milan, Italy

303, Novartis Investiagtional Site; 🇩🇪 Würzburg, Bayern, Germany

101, Novartis Investigational Site; 🇦🇺 Merewether, New South Wales, Australia

002, Novartis Investigational Site; 🇮🇹 Milan, Italy

301, Novartis Investigational Site; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

302, Novartis Investigational Site; 🇩🇪 Hamburg, Germany