Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2010-2011

Novartis

Status and phase: Completed; Phase 2

Conditions: Seasonal Influenza

Treatments: Biological: Seasonal flu vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01152814

2010-018603-29 (EudraCT Number)

V70_25S

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to elderly subjects

Enrollment: 64 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Males and females volunteers of 65 years of age or older
• Mentally competent
• Willing and able to give written informed consent prior to study entry.
• Able to comply with all the study requirements.
• In general good health

Key Exclusion Criteria:

• Any serious chronic or acute disease
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
• Known or suspected impairment/alteration of immune function
• Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
• Within the past 6 months, they have had laboratory confirmed influenza disease or received influenza vaccine
• Fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination
• Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Arm 1

Experimental group

Description:

No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit

Treatment:

Biological: Seasonal flu vaccine