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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Other interventions - CSL425
Other interventions - 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
Other interventions: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
Other interventions: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
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Intervention code [1]
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Other interventions
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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/ct2/show/NCT00940108
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Trial related presentations / publications
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00940108
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