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Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

NCT ID: NCT00518453

Last Updated: 2016-12-01

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

PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2007-08-31

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 and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

Detailed Description

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Conditions

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Influenza

Keywords

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Influenza vaccine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1: Fluvirin

Group Type EXPERIMENTAL

Surface antigen inactivated influenza vaccine

Intervention Type BIOLOGICAL

1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition

Interventions

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Surface antigen inactivated influenza vaccine

1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion Criteria

* Any serious disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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The Health Centre

Suffolk, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2007-002063-27

Identifier Type: -

Identifier Source: secondary_id

V78P5S

Identifier Type: -

Identifier Source: org_study_id