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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00958243
First received: August 12, 2009
Last updated: February 10, 2012
Last verified: August 2011
Results First Received: July 13, 2011  
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
Condition: Influenza
Interventions: Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Cohort A Placebo, Aged 6 months to less than 3 years
CSL425 (7.5 Mcg) Cohort A 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
CSL425 (15 Mcg) Cohort A 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
Placebo Cohort B Placebo, Aged 3 years to less than 9 years
CSL425 (7.5 Mcg) Cohort B 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
CSL425 (15 Mcg) Cohort B 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years

Participant Flow:   Overall Study
    Placebo Cohort A     CSL425 (7.5 Mcg) Cohort A     CSL425 (15 Mcg) Cohort A     Placebo Cohort B     CSL425 (7.5 Mcg) Cohort B     CSL425 (15 Mcg) Cohort B  
STARTED     26     105     96     28     109     109  
COMPLETED     24     99     82     25     100     99  
NOT COMPLETED     2     6     14     3     9     10  
Withdrawal by Subject                 0                 1                 3                 1                 1                 5  
Lost to Follow-up                 2                 5                 11                 2                 8                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo Cohort A Placebo, Aged 6 months to less than 3 years
CSL425 (7.5 Mcg) Cohort A 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
CSL425 (15 Mcg) Cohort A 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
Placebo Cohort B Placebo, Aged 3 years to less than 9 years
CSL425 (7.5 Mcg) Cohort B 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
CSL425 (15 Mcg) Cohort B 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
Total Total of all reporting groups

Baseline Measures
    Placebo Cohort A     CSL425 (7.5 Mcg) Cohort A     CSL425 (15 Mcg) Cohort A     Placebo Cohort B     CSL425 (7.5 Mcg) Cohort B     CSL425 (15 Mcg) Cohort B     Total  
Number of Participants  
[units: participants]
  26     105     96     28     109     109     473  
Age  
[units: participants]
             
<=18 years     26     105     96     28     109     109     473  
Between 18 and 65 years     0     0     0     0     0     0     0  
>=65 years     0     0     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  1.87  ± 0.77     1.73  ± 0.72     1.85  ± 0.66     5.90  ± 1.71     5.94  ± 1.71     5.91  ± 1.70     3.93  ± 2.45  
Gender  
[units: participants]
             
Female     11     57     44     13     53     50     228  
Male     15     48     52     15     56     59     245  
Region of Enrollment  
[units: participants]
             
United States     26     105     96     28     109     109     473  



  Outcome Measures
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1.  Primary:   Seroconversion Rate 21 Days After First Study Vaccination   [ Time Frame: 21 days after the first study vaccination ]

2.  Primary:   Seroconversion Rate 21 Days After Second Study Vaccination   [ Time Frame: 21 days after the second study vaccination ]

3.  Primary:   Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination   [ Time Frame: 21 days after the first study vaccination ]

4.  Primary:   Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination   [ Time Frame: 21 days after the second study vaccination ]

5.  Secondary:   Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A   [ Time Frame: During the 7 days after each study vaccination ]

6.  Secondary:   Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A   [ Time Frame: During the 7 days after each study vaccination ]

7.  Secondary:   Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B   [ Time Frame: During the 7 days after each study vaccination ]

8.  Secondary:   Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B   [ Time Frame: During the 7 days after each study vaccination ]

9.  Secondary:   Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination   [ Time Frame: During the 21 days after each vaccination ]

10.  Secondary:   Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)   [ Time Frame: Up to 180 days after the last vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Russell Basser
Organization: CSL Limited
phone: 61393891569
e-mail: russell.basser@csl.com.au


No publications provided


Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT00958243     History of Changes
Other Study ID Numbers: CSLCT-CAL-09-62
Study First Received: August 12, 2009
Results First Received: July 13, 2011
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration