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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00940108
Registration number
NCT00940108
Ethics application status
Date submitted
13/07/2009
Date registered
15/07/2009
Date last updated
28/06/2018
Titles & IDs
Public title
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
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Scientific title
A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.
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Secondary ID [1]
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CSLCT-CAL-09-60
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza Caused by the Novel Influenza A (H1N1) Virus
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - CSL425
Treatment: Other - CSL425
Experimental: 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
Experimental: 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
Treatment: Other: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
Treatment: Other: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination
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Assessment method [1]
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HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
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Timepoint [1]
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Before and 21 days after the first vaccination
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Primary outcome [2]
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HI Antibody Titre Seroconversion Rate After the Second Vaccination
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Assessment method [2]
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HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
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Timepoint [2]
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Before and 21 days after the second vaccination
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Primary outcome [3]
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Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination
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Assessment method [3]
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GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
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Timepoint [3]
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Before and 21 days after the first vaccination
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Primary outcome [4]
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GMFI in the HI Antibody Titre After the Second Vaccination
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Assessment method [4]
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GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
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Timepoint [4]
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Before and 21 days after the second vaccination
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Primary outcome [5]
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Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination
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Assessment method [5]
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Timepoint [5]
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21 days after the first vaccination
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Primary outcome [6]
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Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination
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Assessment method [6]
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Timepoint [6]
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21 days after the second vaccination
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Secondary outcome [1]
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Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
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Assessment method [1]
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Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size \> 100 mm for injection site redness and induration/swelling; Temperature \> 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.
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Timepoint [1]
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During the 7 days after each vaccination
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Secondary outcome [2]
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Duration of Solicited AEs After the First Vaccination
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Assessment method [2]
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Solicited AEs included AEs that were specifically sought for.
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Timepoint [2]
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During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.
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Secondary outcome [3]
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Duration of Solicited AEs After the Second Vaccination
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Assessment method [3]
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Solicited AEs included AEs that were specifically sought for.
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Timepoint [3]
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During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.
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Secondary outcome [4]
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Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
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Assessment method [4]
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An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
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Timepoint [4]
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Up to 180 days after the last vaccination
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Secondary outcome [5]
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Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination
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Assessment method [5]
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Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.
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Timepoint [5]
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During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs
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Eligibility
Key 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.
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Minimum age
6
Months
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Maximum age
8
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2010
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Sample size
Target
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Accrual to date
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Final
370
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Study Site - Westmead
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Recruitment hospital [2]
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Study Site - Brisbane
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Recruitment hospital [3]
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Study Site - North Adelaide
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Recruitment hospital [4]
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Study Site - Carlton
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Recruitment hospital [5]
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Study Site - Subiaco
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4006 - Brisbane
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Recruitment postcode(s) [3]
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5006 - North Adelaide
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Recruitment postcode(s) [4]
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3010 - Carlton
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Recruitment postcode(s) [5]
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6027 - Subiaco
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seqirus
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT00940108
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Clinical Director Vaccines
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Address
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Seqirus
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00940108
Download to PDF