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Trial record 3 of 12 for:    CSL+H1N1+Influenza+Vaccine

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

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ClinicalTrials.gov Identifier: NCT00940108
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : November 20, 2013
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Seqirus

Tracking Information
First Submitted Date  ICMJE July 13, 2009
First Posted Date  ICMJE July 15, 2009
Results First Submitted Date  ICMJE July 9, 2013
Results First Posted Date  ICMJE November 20, 2013
Last Update Posted Date June 28, 2018
Study Start Date  ICMJE August 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
  • Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination [ Time Frame: Before and 21 days 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.
  • HI Antibody Titre Seroconversion Rate After the Second Vaccination [ Time Frame: Before and 21 days 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.
  • Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination [ Time Frame: Before and 21 days 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.
  • GMFI in the HI Antibody Titre After the Second Vaccination [ Time Frame: Before and 21 days 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.
  • Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination [ Time Frame: 21 days after the first vaccination ]
  • Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination [ Time Frame: 21 days after the second vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2009)
Immunogenicity [ Time Frame: 21 days after each vaccination ]
Change History Complete list of historical versions of study NCT00940108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
  • Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination [ Time Frame: During the 7 days after each 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.
  • Duration of Solicited AEs After the First Vaccination [ Time Frame: During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7. ]
    Solicited AEs included AEs that were specifically sought for.
  • Duration of Solicited AEs After the Second Vaccination [ Time Frame: During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7. ]
    Solicited AEs included AEs that were specifically sought for.
  • Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) [ Time Frame: Up to 180 days after the last vaccination ]
    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).
  • Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination [ Time Frame: During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2009)
  • Frequency,duration and intensity of solicited adverse events [ Time Frame: During the 7 days after each vaccination ]
  • Frequency, duration and intensity of unsolicited adverse events [ Time Frame: During the 21 days after each vaccination ]
  • Incidence of Serious Adverse Events, Adverse Events of Special Interest (AESI's) and new onset of Chronic Illnesses [ Time Frame: From the time of providing informed consent up to 180 days after the last vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza Caused by the Novel Influenza A (H1N1) Virus
Intervention  ICMJE Biological: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
Study Arms  ICMJE
  • 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
    Intervention: Biological: CSL425
  • 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
    Intervention: Biological: CSL425
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2013)
370
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2009)
400
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00940108
Other Study ID Numbers  ICMJE CSLCT-CAL-09-60
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seqirus
Study Sponsor  ICMJE Seqirus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Director Vaccines Seqirus
PRS Account Seqirus
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP