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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00958126
First received: August 12, 2009
Last updated: August 31, 2012
Last verified: August 2012

August 12, 2009
August 31, 2012
August 2009
November 2009   (final data collection date for primary outcome measure)
  • Seroconversion Rate 21 Days After the First Vaccination [ Time Frame: 21 days after the first vaccination ] [ Designated as safety issue: No ]
    Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
  • Seroconversion Rate 21 Days After the Second Vaccination [ Time Frame: 21 days after the second vaccination ] [ Designated as safety issue: No ]
    Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
  • Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination [ Time Frame: 21 days after the first vaccination ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination [ Time Frame: 21 days after the second vaccination ] [ Designated as safety issue: No ]
Immunogenicity [ Time Frame: 21 days after the first vaccination and again 21 days after the second vaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00958126 on ClinicalTrials.gov Archive Site
  • Frequency and Intensity of Solicited Adverse Events After the First Vaccination [ Time Frame: During the 7 days after the first vaccination ] [ Designated as safety issue: Yes ]
    Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.
  • Duration of Solicited Local Adverse Events After the First Vaccination [ Time Frame: During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs ] [ Designated as safety issue: Yes ]
  • Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) [ Time Frame: Up to 180 days after the last vaccination ] [ Designated as safety issue: Yes ]
    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 (UAE) After the First or Second Vaccination [ Time Frame: Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI ] [ Designated as safety issue: Yes ]

    Unsolicited adverse event (UAE) grading:

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

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

    Grade 3 (severe): Symptoms that prevented normal, everyday 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 and new onset of chronic illness [ Time Frame: 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 Adults in the USA
A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older

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 adults

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
  • Biological: CSL425
    CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
  • Biological: CSL425
    CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
  • Biological: Placebo
    Vaccine diluent, thimerosal 0.01% (weight/volume).
  • Experimental: CSL425 (7.5 mcg)
    7.5 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 (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
  • Placebo Comparator: Placebo
    Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
    Intervention: Biological: Placebo
Talaat KR, Greenberg ME, Lai MH, Hartel GF, Wichems CH, Rockman S, Jeanfreau RJ, Ghosh MR, Kabongo ML, Gittleson C, Karron RA. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis. 2010 Nov 1;202(9):1327-37.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1313
April 2010
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged 18 and older, inclusive, at the time of providing informed consent.
  • Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Exclusion Criteria:

  • Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00958126
CSLCT-CAL-09-61
Yes
CSL Limited
CSL Limited
Not Provided
Study Director: Director, Vaccines Clinical Development CSL Limited
CSL Limited
August 2012

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