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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Seasonal Influenza

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

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

Group Type EXPERIMENTAL

Seasonal flu vaccine

Intervention Type BIOLOGICAL

This phase II is performed as a multicenters study site in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22)

Interventions

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Seasonal flu vaccine

This phase II is performed as a multicenters study site in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes