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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00940108
First received: July 13, 2009
Last updated: October 28, 2013
Last verified: October 2013

July 13, 2009
October 28, 2013
August 2009
October 2009   (final data collection date for primary outcome measure)
  • Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination [ Time Frame: Before and 21 days after the first vaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Immunogenicity [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00940108 on ClinicalTrials.gov Archive Site
  • Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination [ Time Frame: During the 7 days after each vaccination ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • Frequency,duration and intensity of solicited adverse events [ Time Frame: During the 7 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Frequency, duration and intensity of unsolicited adverse events [ Time Frame: During the 21 days after each vaccination ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza Caused by the Novel Influenza A (H1N1) Virus
Biological: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
  • 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
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.
 
Completed
370
April 2010
October 2009   (final data collection date for primary outcome measure)

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.
Both
6 Months to 8 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00940108
CSLCT-CAL-09-60
Yes
CSL Limited
CSL Limited
Not Provided
Not Provided
CSL Limited
October 2013

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