A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers

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

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-06-30

Brief Summary

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This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged between 18 and 60 years.

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Detailed Description

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Conditions

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Influenza, Human

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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Trivalent Influenza Vaccine

The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection.

Group Type EXPERIMENTAL

Trivalent Influenza Vaccine

Intervention Type BIOLOGICAL

Interventions

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Trivalent Influenza Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Males or females aged between 18 and 60 years at the time of vaccination.
* Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Exclusion Criteria

* Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
* Clinical signs of an active infection.
* A clinically significant medical condition.
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
* Females who are pregnant or lactating.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes