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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00940108




Registration number
NCT00940108
Ethics application status
Date submitted
13/07/2009
Date registered
14/07/2009
Date last updated
25/04/2018

Titles & IDs
Public title
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
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.
Secondary ID [1] 0 0
CSLCT-CAL-09-60
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza Caused by the Novel Influenza A (H1N1) Virus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination - 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.
Timepoint [1] 0 0
Before and 21 days after the first vaccination
Primary outcome [2] 0 0
HI Antibody Titre Seroconversion Rate After the Second Vaccination - 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.
Timepoint [2] 0 0
Before and 21 days after the second vaccination
Primary outcome [3] 0 0
Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination - 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.
Timepoint [3] 0 0
Before and 21 days after the first vaccination
Primary outcome [4] 0 0
GMFI in the HI Antibody Titre After the Second Vaccination - 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.
Timepoint [4] 0 0
Before and 21 days after the second vaccination
Primary outcome [5] 0 0
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination
Timepoint [5] 0 0
21 days after the first vaccination
Primary outcome [6] 0 0
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination
Timepoint [6] 0 0
21 days after the second vaccination
Secondary outcome [1] 0 0
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination - 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.
Timepoint [1] 0 0
During the 7 days after each vaccination
Secondary outcome [2] 0 0
Duration of Solicited AEs After the First Vaccination - Solicited AEs included AEs that were specifically sought for.
Timepoint [2] 0 0
During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.
Secondary outcome [3] 0 0
Duration of Solicited AEs After the Second Vaccination - Solicited AEs included AEs that were specifically sought for.
Timepoint [3] 0 0
During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.
Secondary outcome [4] 0 0
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) - 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).
Timepoint [4] 0 0
Up to 180 days after the last vaccination
Secondary outcome [5] 0 0
Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination - 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.
Timepoint [5] 0 0
During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs

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.
Minimum age
6 Months
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Study Site - Westmead
Recruitment hospital [2] 0 0
Study Site - Brisbane
Recruitment hospital [3] 0 0
Study Site - North Adelaide
Recruitment hospital [4] 0 0
Study Site - Carlton
Recruitment hospital [5] 0 0
Study Site - Subiaco
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4006 - Brisbane
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3010 - Carlton
Recruitment postcode(s) [5] 0 0
6027 - Subiaco

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Seqirus
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00940108
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Director Vaccines
Address 0 0
Seqirus
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications