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

Outcomes
Primary outcome [1] 0 0
Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination
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
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
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
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
Timepoint [1] 0 0
During the 7 days after each vaccination
Secondary outcome [2] 0 0
Duration of Solicited AEs After the First Vaccination
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
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)
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
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
Sex
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
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
370
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/study/NCT00940108
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00940108