Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012

Novartis

Status and phase: Completed; Phase 2

Conditions: Seasonal Influenza

Treatments: Biological: Seasonal Influenza Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01344057

2010-021841-38 (EudraCT Number)

V70_32S

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: 63 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.
• Individuals able to comply with all the study requirements.
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
• Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.

Key Exclusion Criteria:

• Individuals with any serious chronic or acute disease.
• Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination.
• Individuals with known or suspected impairment/alteration of immune function.
• Individuals with known or suspected history of drug or alcohol abuse.
• Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject.
• Individuals within the past 6 months, they have: had any seasonal or pandemic laboratory confirmed influenza disease; received any seasonal or pandemic influenza vaccine.
• Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
• Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.
• Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
• 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.
• Individuals who are part of study personnel or close family members conducting this study.
• BMI > 35 kg/m2.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine

Other 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 Influenza Vaccine