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
  Purpose

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.


Condition Intervention Phase
Influenza Caused by the Novel Influenza A (H1N1) Virus
Biological: CSL425
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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.

Resource links provided by NLM:


Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 370
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
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
Biological: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free

  Eligibility

Ages Eligible for Study:   6 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940108

Locations
Australia, New South Wales
Study Site
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Study Site
Brisbane, Queensland, Australia, 4006
Australia, South Australia
Study Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Study Site
Carlton, Victoria, Australia, 3010
Australia, Western Australia
Study Site
Subiaco, Western Australia, Australia, 6027
Sponsors and Collaborators
CSL Limited
  More Information

Publications:
Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT00940108     History of Changes
Other Study ID Numbers: CSLCT-CAL-09-60
Study First Received: July 13, 2009
Results First Received: July 9, 2013
Last Updated: October 28, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014