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Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects

NCT ID: NCT01411358

Last Updated: 2012-07-12

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

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Detailed Description

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Conditions

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Influenza

Keywords

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influenza vaccine immunogenicity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AdimFlu-S 2011-2012

Group Type EXPERIMENTAL

non-elderly aged between 18 and 60

Intervention Type BIOLOGICAL

one dose of 0.5mL AdimFlu-S

elderly aged over 60

Intervention Type BIOLOGICAL

one dose of 0.5mL AdimFlu-S

Interventions

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non-elderly aged between 18 and 60

one dose of 0.5mL AdimFlu-S

Intervention Type BIOLOGICAL

elderly aged over 60

one dose of 0.5mL AdimFlu-S

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Males or non-pregnant females and aged ≥ 18 years;
* Willing and able to adhere to visit schedules and all study requirements;
* Subjects read and signed the study-specific informed consent.

Exclusion Criteria

* Subject or his/her family is employed by the participated hospital;
* Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
* History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication
* Personal or family history of Guillain-Barré Syndrome
* An acute febrile illness within 1 week prior to vaccination;
* Current upper respiratory illness, including the common cold or nasal congestion within 72 hours
* Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough
* Female subjects who are pregnant during the study
* Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent
* Immunodeficiency, or under immunosuppressive treatment
* Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
* Receipt of any blood products, including immunoglobulin in the prior 3 months;
* Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Adimmune Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gin-Hsiang Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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FLU11T12A

Identifier Type: -

Identifier Source: org_study_id