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Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

NCT ID: NCT01752881

Last Updated: 2012-12-19

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

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-09-30

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 three weeks 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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AdimFlu-S

Group Type EXPERIMENTAL

Influenza vaccine (split virion, inactivated)

Intervention Type BIOLOGICAL

AdimFlu-S, Inactivated Influenza Vaccine Trivalent Types A and B (Split) Formulation 2012-2013

Dosage: 0.5mL/per syringe

Administration route: Intramuscular Injection, once

AdimFlu-S

Intervention Type BIOLOGICAL

Interventions

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Influenza vaccine (split virion, inactivated)

AdimFlu-S, Inactivated Influenza Vaccine Trivalent Types A and B (Split) Formulation 2012-2013

Dosage: 0.5mL/per syringe

Administration route: Intramuscular Injection, once

Intervention Type BIOLOGICAL

AdimFlu-S

Intervention Type BIOLOGICAL

Other Intervention Names

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AdimFlu-S Influenza Vaccine

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

\-
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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Chih-Jen Chang, 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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FLU12T13A

Identifier Type: -

Identifier Source: org_study_id