A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-03-31

Brief Summary

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The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.

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Detailed Description

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Conditions

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Influenza Caused by the Novel Influenza A (H1N1) Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CSL425 (15 mcg)

15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Group Type EXPERIMENTAL

CSL425

Intervention Type BIOLOGICAL

CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)

CSL425 (30 mcg)

30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Group Type EXPERIMENTAL

CSL425

Intervention Type BIOLOGICAL

CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)

Interventions

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CSL425

CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)

Intervention Type BIOLOGICAL

CSL425

CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female aged \>= 18 to \< 65 years at the time of providing informed consent.

Exclusion Criteria

* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes