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

Seqirus

Status and phase: Completed; Phase 3

Conditions: Influenza, Human

Treatments: Biological: Novartis Seasonal Influenza Vaccine; Biological: Novartis Investigational H5N1 vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02091908

V87_25

Details and patient eligibility

About

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.

Enrollment: 540 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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540 participants in 4 patient groups

Arm 1: aH5N1 adult

Experimental group

Description:

aH5N1 healthy and non-healthy adults

Treatment:

Biological: Novartis Investigational H5N1 vaccine

Biological: Novartis Investigational H5N1 vaccine

Arm 2: aH5N1 elderly

Experimental group

Description:

aH5N1 healthy and non-healthy elderly

Treatment:

Biological: Novartis Investigational H5N1 vaccine

Biological: Novartis Investigational H5N1 vaccine

Arm 3: aTIV adult

Active Comparator group

Description:

aTIV healthy and non-healthy adults

Treatment:

Biological: Novartis Seasonal Influenza Vaccine

Biological: Novartis Seasonal Influenza Vaccine

Arm 4: aTIV elderly

Active Comparator group

Description:

aTIV healthy and non-healthy elderly

Treatment:

Biological: Novartis Seasonal Influenza Vaccine

Biological: Novartis Seasonal Influenza Vaccine