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

NCT ID: NCT00940108

Last Updated: 2018-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-04-30

Brief Summary

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

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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 hemagglutinin 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-free

CSL425 (30 mcg)

30 mcg of hemagglutinin 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-free

Interventions

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CSL425

CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free

Intervention Type BIOLOGICAL

CSL425

CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female aged \>= 6 months to \< 9 years at the time of the first study vaccination.
* For children \< 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation.

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

6 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seqirus

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Director Vaccines

Role: STUDY_DIRECTOR

Seqirus

Locations

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Study Site

Westmead, New South Wales, Australia

Site Status

Study Site

Brisbane, Queensland, Australia

Site Status

Study Site

North Adelaide, South Australia, Australia

Site Status

Study Site

Carlton, Victoria, Australia

Site Status

Study Site

Subiaco, Western Australia, Australia

Site Status

Countries

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Australia

References

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Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, Hartel G, Lai M, Basser R, Gittleson C, Greenberg M. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA. 2010 Jan 6;303(1):37-46. doi: 10.1001/jama.2009.1911. Epub 2009 Dec 21.

Reference Type RESULT
PMID: 20026597 (View on PubMed)

Other Identifiers

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CSLCT-CAL-09-60

Identifier Type: -

Identifier Source: org_study_id

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