Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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preservative free inactivated split influenza vaccine using the strain composition 2006/2007

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy adults aged \>18 years

Exclusion Criteria

* serious chronic diseases or significant acute infections requiring systemic antibiotic treatment
* history of any anaphylaxis, serious vaccine reactions
* hypersensitivity against vaccine components
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* known or suspected impairment/alteration of immune function
* more than one injection of influenza vaccine received or laboratory confirmed influenza disease
* within last 6 months: influenza vaccination received

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes