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Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season

NCT ID: NCT02381418

Last Updated: 2016-12-22

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

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-03-31

Brief Summary

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Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition in two groups of subjects in good health: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).

Detailed Description

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Conditions

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Influenza

Keywords

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Influenza Vaccine Committee for Medicinal Products for Human Use (CHMP) criteria

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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1

Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "

Group Type EXPERIMENTAL

Trivalent influenza subunit vaccine Influvac

Intervention Type BIOLOGICAL

"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "

Interventions

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Trivalent influenza subunit vaccine Influvac

"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Willing and able to give informed consent and able to adhere to all protocol required study procedures.
* Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
* Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator

Exclusion Criteria

* Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
* A serious adverse reaction after a previous (influenza) vaccination.
* Presence of any significant condition that may prohibit inclusion as determined by the investigator.
* Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
* A history of Guillain-Barré syndrome or active neurological disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Facility ID ORG-001075

Maroubra, , Australia

Site Status

Countries

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Australia

Other Identifiers

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INFL3014

Identifier Type: -

Identifier Source: org_study_id