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

NCT ID: NCT00958126

Last Updated: 2017-11-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1313 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 adults

Detailed Description

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Conditions

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Influenza

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 (7.5 mcg)

7.5 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 (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 0.01% (weight/volume).

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 0.01% (weight/volume).

Placebo

Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Vaccine diluent, thimerosal 0.01% (weight/volume).

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 0.01% (weight/volume).

Intervention Type BIOLOGICAL

Placebo

Vaccine diluent, thimerosal 0.01% (weight/volume).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 18 and older, inclusive, at the time of providing informed consent.
* Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Exclusion Criteria

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

18 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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Director, Vaccines Clinical Development

Role: STUDY_DIRECTOR

Seqirus

Locations

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Study Site

Huntsville, Alabama, United States

Site Status

Study Site

San Diego, California, United States

Site Status

Study Site

Melbourne, Florida, United States

Site Status

Study Site

Peoria, Illinois, United States

Site Status

Study Site

South Bend, Indiana, United States

Site Status

Study Site

Metairie, Louisiana, United States

Site Status

Study Site

Baltimore, Maryland, United States

Site Status

Study Site

Rockville, Maryland, United States

Site Status

Study Site

Austin, Texas, United States

Site Status

Study Site

Fort Worth, Texas, United States

Site Status

Study Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Talaat KR, Greenberg ME, Lai MH, Hartel GF, Wichems CH, Rockman S, Jeanfreau RJ, Ghosh MR, Kabongo ML, Gittleson C, Karron RA. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis. 2010 Nov 1;202(9):1327-37. doi: 10.1086/656601.

Reference Type RESULT
PMID: 20874515 (View on PubMed)

Other Identifiers

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CSLCT-CAL-09-61

Identifier Type: -

Identifier Source: org_study_id