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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00938639
First received: July 13, 2009
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.


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, Single-centre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's Monovalent H1N1 Influenza Virus Vaccine in Healthy Adults Aged 18 to < 65 Years.

Resource links provided by NLM:


Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination [ Time Frame: Before and 21 days after the first vaccination ] [ Designated as safety issue: No ]
    Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.

  • HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination [ Time Frame: Before and 21 days after the second vaccination ] [ Designated as safety issue: No ]
    Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination 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 and MN Antibody Titre After the First Vaccination [ Time Frame: Before and 21 days after the first vaccination ] [ Designated as safety issue: No ]
    GMFI in 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 and MN Antibody Titer After the Second Vaccination [ Time Frame: Before and 21 days after the second vaccination ] [ Designated as safety issue: No ]
    GMFI in 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 or MN 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 or MN 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:
  • HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group [ Time Frame: Before and 21 days after the first vaccination ] [ Designated as safety issue: No ]

    Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.

    Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.


  • HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group [ Time Frame: Before and 21 days after the second vaccination ] [ Designated as safety issue: No ]

    Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.

    Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.


  • GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group [ Time Frame: Before and 21 days after the first vaccination ] [ Designated as safety issue: No ]

    GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.

    Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.


  • GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group [ Time Frame: Before and 21 days after the second vaccination ] [ Designated as safety issue: No ]

    GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.

    Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.


  • Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group [ Time Frame: 21 days after the first vaccination ] [ Designated as safety issue: No ]
    Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.

  • Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group [ Time Frame: 21 days after the second vaccination ] [ Designated as safety issue: No ]
    Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.

  • Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination [ Time Frame: Before and 21 days after each vaccination ] [ Designated as safety issue: No ]

    The number of participants with a baseline titre less than 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre less than 1:10 are presented in this outcome measure while those with a baseline titre of 1:10 or more are presented in a separate outcome measure.

    Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.


  • Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination [ Time Frame: Before and 21 days after each vaccination ] [ Designated as safety issue: No ]

    The number of participants with a baseline titre greater than or equal to 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre of 1:10 or more are presented in this outcome measure while those with a baseline titre less than 1:10 are presented in a separate outcome measure.

    Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre (ie, a significant increase in antibody titre after vaccination).


  • GMFI in the HI Antibody Titre 180 Days After the Second Vaccination [ Time Frame: 21 days and 180 days after the second vaccination ] [ Designated as safety issue: No ]
    The GMFI in antibody titre was calculated by taking the anti-logs of the means of the log transformed fold-increases in the antibody titre 180 days after the second vaccination over the antibody titre 21 days after the second vaccination.

  • Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination [ Time Frame: 180 days after the second vaccination ] [ Designated as safety issue: No ]
  • Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination [ Time Frame: From Day 0 to Day 6 after the first vaccination ] [ Designated as safety issue: Yes ]
    Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.

  • Duration of Solicited Local AEs After the First Vaccination [ Time Frame: From Day 0 to Day 6 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.

  • Frequency and Intensity of Solicited Local AEs After the Second Vaccination [ Time Frame: From Day 0 to Day 6 after the second vaccination ] [ Designated as safety issue: Yes ]
    Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.

  • Duration of Solicited Local AEs After the Second Vaccination [ Time Frame: From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7 ] [ Designated as safety issue: Yes ]
    Solicited AEs included AEs that were specifically sought for.

  • Frequency and Intensity of Solicited Systemic AEs After the First Vaccination [ Time Frame: From Day 0 to Day 6 after the first vaccination ] [ Designated as safety issue: Yes ]
    Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.

  • Duration of Solicited Systemic AEs After the First Vaccination [ Time Frame: From Day 0 to Day 6 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.

  • Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination [ Time Frame: From Day 0 to Day 6 after the second vaccination ] [ Designated as safety issue: Yes ]
    Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.

  • Duration of Solicited Systemic AEs After the Second Vaccination [ Time Frame: From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is 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 AEs [ Time Frame: From Day 0 to Day 20 after 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.

    The grading definitions were:

    Mild (Grade 1): Symptoms were easily tolerated and did not interfere with daily activities.

    Moderate (Grade 2): Enough discomfort to cause some interference with daily activities.

    Severe (Grade 3): Incapacitating, with inability to work or do usual activities.



Enrollment: 240
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CSL425 (15 mcg)
15 mcg of haemagglutinin 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 0.01% (weight/volume)
Experimental: CSL425 (30 mcg)
30 mcg of haemagglutinin 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 0.01% (weight/volume)

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female aged >= 18 to < 65 years at the time of providing informed consent.

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: NCT00938639

Locations
Australia, South Australia
Study Site
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
CSL Limited
Investigators
Study Director: Director, Vaccines Clinical Development CSL Limited
  More Information

Publications:
Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT00938639     History of Changes
Other Study ID Numbers: CSLCT-CAL-09-59
Study First Received: July 13, 2009
Results First Received: July 24, 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 September 16, 2014