A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00959049
First received: August 12, 2009
Last updated: August 25, 2011
Last verified: August 2011
Results First Received: July 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: CSL's Influenza Virus Vaccine (Afluria)
Biological: Influenza Virus Vaccine (Fluzone)

  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
Participants were enrolled into this study during the autumn of 2009 at 23 sites in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1474 participants were enrolled, vaccinated and analyzed.

Reporting Groups
  Description
Afluria Cohort A Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
Afluria Cohort B Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
Afluria Cohort C Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
Fluzone Cohort A Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Fluzone Cohort B Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Fluzone Cohort C Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.

Participant Flow:   Overall Study
    Afluria Cohort A     Afluria Cohort B     Afluria Cohort C     Fluzone Cohort A     Fluzone Cohort B     Fluzone Cohort C  
STARTED     231     254     254     228     257     250  
COMPLETED     213     247     253     217     248     249  
NOT COMPLETED     18     7     1     11     9     1  
Adverse Event                 1                 0                 0                 0                 0                 0  
Lost to Follow-up                 17                 5                 1                 10                 9                 1  
Contraindicated medication                 0                 0                 0                 1                 0                 0  
Withdrawal by Subject                 0                 2                 0                 0                 0                 0  



  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.
No text entered.

Reporting Groups
  Description
Afluria Cohort A Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
Afluria Cohort B Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
Afluria Cohort C Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
Fluzone Cohort A Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Fluzone Cohort B Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Fluzone Cohort C Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Total Total of all reporting groups

Baseline Measures
    Afluria Cohort A     Afluria Cohort B     Afluria Cohort C     Fluzone Cohort A     Fluzone Cohort B     Fluzone Cohort C     Total  
Number of Participants  
[units: participants]
  231     254     254     228     257     250     1474  
Age  
[units: participants]
             
<=18 years     231     254     254     228     257     250     1474  
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
  1.94  ± 0.667     5.93  ± 1.725     12.98  ± 2.388     1.96  ± 0.673     5.82  ± 1.748     12.86  ± 2.474     7.06  ± 4.855  
Gender  
[units: participants]
             
Female     119     140     121     101     127     120     728  
Male     112     114     133     127     130     130     746  
Region of Enrollment  
[units: participants]
             
United States     231     254     254     228     257     250     1474  



  Outcome Measures
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1.  Primary:   Geometric Mean Titer 30 Days After the Last Study Vaccination   [ Time Frame: 30 days after the last study vaccination ]

2.  Primary:   Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination   [ Time Frame: 30 days after the last study vaccination ]

3.  Secondary:   Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)   [ Time Frame: 7 days after each vaccination ]

4.  Secondary:   Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B   [ Time Frame: 7 days after each vaccination ]

5.  Secondary:   Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C   [ Time Frame: 7 days after vaccination ]

6.  Secondary:   Frequency and Intensity of Unsolicited Adverse Events (UAEs)   [ Time Frame: 30 days after each vaccination ]

7.  Secondary:   New Onset of Chronic Illnesses (NOCIs)   [ Time Frame: 6 months after last study vaccination ]

8.  Secondary:   Serious Adverse Events (SAEs)   [ Time Frame: 6 months after last study vaccination ]

9.  Secondary:   Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)   [ Time Frame: 7 days after each vaccination ]

10.  Secondary:   Duration of Local and Systemic Solicited Symptoms, Cohort B   [ Time Frame: 7 days after each vaccination ]

11.  Secondary:   Duration of Local and Systemic Solicited Symptoms, Cohort C   [ Time Frame: 7 days after 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: Program Director, Clinical Research and Development
Organization: CSL
e-mail: csl.clinicaltrials@csl.com.au


No publications provided


Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT00959049     History of Changes
Other Study ID Numbers: CSLCT-USF-07-36
Study First Received: August 12, 2009
Results First Received: July 3, 2011
Last Updated: August 25, 2011
Health Authority: United States: Food and Drug Administration