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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
History of Changes
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
  Hide Participant Flow

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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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 ]

Measure Type Primary
Measure Title Geometric Mean Titer 30 Days After the Last Study Vaccination
Measure Description No text entered.
Time Frame 30 days after the last study vaccination  
Safety Issue No  

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.
Per-protocol population

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.

Measured Values
    Afluria Cohort A     Afluria Cohort B     Afluria Cohort C     Fluzone Cohort A     Fluzone Cohort B     Fluzone Cohort C  
Number of Participants Analyzed  
[units: participants]
 		  195     229     230     201     236     233  
Geometric Mean Titer 30 Days After the Last Study Vaccination  
[units: Titers]
Geometric Mean ( 95% Confidence Interval ) 		           
H1N1 (A/Brisbane/59/2007)     235.44  
  ( 199.67 to 277.61 )   		  345.50  
  ( 295.54 to 403.92 )   		  652.99  
  ( 566.91 to 752.14 )   		  227.19  
  ( 188.39 to 273.98 )   		  351.88  
  ( 303.29 to 408.25 )   		  652.17  
  ( 569.59 to 746.73 )  
H3N2 ( A/Uruguay/716/2007)     309.19  
  ( 253.49 to 377.13 )   		  909.22  
  ( 772.67 to 1069.90 )   		  948.86  
  ( 824.88 to 1091.46 )   		  340.49  
  ( 283.98 to 408.25 )   		  870.34  
  ( 751.62 to 1007.80 )   		  1069.7  
  ( 934.77 to 1224.11 )  
B (B/Brisbane/60/2008)     73.46  
  ( 59.32 to 90.97 )   		  122.71  
  ( 102.55 to 146.83 )   		  107.92  
  ( 71.77 to 126.91 )   		  57.92  
  ( 46.92 to 71.49 )   		  104.91  
  ( 88.67 to 123.42 )   		  126.99  
  ( 107.53 to 149.97 )  

No statistical analysis provided for Geometric Mean Titer 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 ]

Measure Type Primary
Measure Title Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
Measure Description Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Time Frame 30 days after the last study vaccination  
Safety Issue No  

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.
Per-Protocol Population

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.

Measured Values
    Afluria Cohort A     Afluria Cohort B     Afluria Cohort C     Fluzone Cohort A     Fluzone Cohort B     Fluzone Cohort C  
Number of Participants Analyzed  
[units: participants]
 		  195     229     230     201     236     233  
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination  
[units: Percentage of participants]
Number ( 95% Confidence Interval ) 		           
H1N1 (A/Brisbane/59/2007)     84  
  ( 78 to 89 )   		  66  
  ( 59 to 72 )   		  64  
  ( 57 to 70 )   		  74  
  ( 67 to 80 )   		  64  
  ( 58 to 70 )   		  61  
  ( 55 to 68 )  
H3N2 ( A/Uruguay/716/2007)     83  
  ( 77 to 88 )   		  71  
  ( 65 to 77 )   		  72  
  ( 66 to 78 )   		  85  
  ( 79 to 90 )   		  74  
  ( 68 to 80 )   		  73  
  ( 66 to 78 )  
B (B/Brisbane/60/2008)     67  
  ( 60 to 73 )   		  73  
  ( 67 to 79 )   		  67  
  ( 31 to 73 )   		  61  
  ( 54 to 68 )   		  76  
  ( 70 to 82 )   		  73  
  ( 67 to 79 )  

No statistical analysis provided for Percentage of Participants With Seroconversion 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 ]

Measure Type Secondary
Measure Title Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Measure Description No text entered.
Time Frame 7 days after each vaccination  
Safety Issue Yes  

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.
Safety population; Afluria Cohort A receiving 2 doses N=96, Fluzone Cohort A receiving 2 doses N=110

Reporting Groups
  Description
Afluria Cohort A Age 6 months to < 3 years
Fluzone Cohort A Age 6 months to < 3 years

Measured Values
    Afluria Cohort A     Fluzone Cohort A  
Number of Participants Analyzed  
[units: participants]
 		  229     228  
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)  
[units: Participants]
 		   
Any local solicited symptom post-dose 1     116     100  
Any pain     98     78  
Grade 3 pain     1     0  
Any redness (> 0 mm)     53     53  
Grade 3 redness (> 30 mm)     0     1  
Any swelling (> 0 mm)     30     26  
Grade 3 swelling (> 30 mm)     1     0  
Any local solicited symptom post-dose 2     30     32  
Any pain     28     22  
Grade 3 pain     0     0  
Any redness (> 0 mm)     15     22  
Grade 3 redness (> 30 mm)     1     0  
Any swelling (> 0 mm)     9     7  
Grade 3 swelling (> 30 mm)     0     0  
Any systemic solicited symptom post-dose 1     171     121  
Any fever (≥ 99.5°F ax or ≥ 100.4°F oral)     85     31  
Grade 3 fever (> 103.1°F ax or > 104.0°F oral)     6     0  
Any nausea/vomiting     27     17  
Grade 3 nausea/vomiting (prevented activities)     22     6  
Any diarrhea     61     54  
Grade 3 diarrhea (prevented activities)     4     3  
Any loss of appetite     73     45  
Grade 3 loss of appetite (prevented activities)     3     1  
Any irritability     134     85  
Grade 3 irritability (prevented activities)     10     5  
Any systemic solicited symptom post-dose 2     48     44  
Any fever (≥ 99.5°F ax or ≥ 100.4°F oral)     14     15  
Grade 3 fever (> 103.1°F ax or > 104.0°F oral)     1     0  
Any nausea/vomiting     4     8  
Grade 3 nausea/vomiting (prevented activities)     2     0  
Any diarrhea     17     16  
Grade 3 diarrhea (prevented activities)     1     0  
Any loss of appetite     15     14  
Grade 3 loss of appetite (prevented activities)     1     0  
Any irritability     38     31  
Grade 3 irritability (prevented activities)     1     0  

No statistical analysis provided for Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)



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

Measure Type Secondary
Measure Title Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Measure Description No text entered.
Time Frame 7 days after each vaccination  
Safety Issue Yes  

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.
Safety population; Afluria cohort B receiving 2 doses N=68, Fluzone cohort B receiving 2 doses N=78

Reporting Groups
  Description
Afluria Cohort B Age 3 to < 9 years
Fluzone Cohort B Age 3 to < 9 years

Measured Values
    Afluria Cohort B     Fluzone Cohort B  
Number of Participants Analyzed  
[units: participants]
 		  252     255  
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B  
[units: Participants]
 		   
Any local solicited symptom post-dose 1     164     152  
Any pain     149     131  
Grade 3 pain     1     4  
Any redness (> 0 mm)     59     60  
Grade 3 redness (> 30 mm)     7     4  
Any swelling (> 0 mm)     36     43  
Grade 3 swelling (> 30 mm)     6     2  
Any local solicited symptom post-dose 2     24     26  
Any pain     23     23  
Grade 3 pain     0     0  
Any redness (> 0 mm)     5     13  
Grade 3 redness (> 30 mm)     0     0  
Any swelling (> 0 mm)     4     11  
Grade 3 swelling (> 30 mm)     0     0  
Any systemic solicited symptom post-dose 1     140     113  
Any fever (≥ 99.5°F ax or ≥ 100.4°F oral)     55     24  
Grade 3 fever (> 103.1°F ax or > 104.0°F oral)     3     1  
Any nausea/vomiting     33     20  
Grade 3 nausea/vomiting (prevented activities)     2     1  
Any diarrhea     17     24  
Grade 3 diarrhea (prevented activities)     0     0  
Any malaise     72     34  
Grade 3 malaise (prevented activities)     9     1  
Any headache     54     41  
Grade 3 headache (prevented activities)     5     0  
Any myalgia     82     63  
Grade 3 myalgia (prevented activities)     1     1  
Any systemic solicited symptom post-dose 2     17     18  
Any fever (≥ 99.5°F ax or ≥ 100.4°F oral)     4     5  
Grade 3 fever (> 103.1°F ax or > 104.0°F oral)     1     0  
Any nausea/vomiting     2     4  
Grade 3 nausea/vomiting (prevented activities)     1     0  
Any diarrhea     6     5  
Grade 3 diarrhea (prevented activities)     0     0  
Any malaise     6     6  
Grade 3 malaise (prevented activities)     0     0  
Any headache     6     8  
Grade 3 headache (prevented activities)     0     0  
Any myalgia     7     12  
Grade 3 myalgia (prevented activities)     0     0  

No statistical analysis provided for Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B



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

Measure Type Secondary
Measure Title Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Measure Description No text entered.
Time Frame 7 days after vaccination  
Safety Issue Yes  

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.
Safety population

Reporting Groups
  Description
Afluria Cohort C Age 9 to < 18 years
Fluzone Cohort C Age 9 to < 18 years

Measured Values
    Afluria Cohort C     Fluzone Cohort C  
Number of Participants Analyzed  
[units: participants]
 		  254     250  
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C  
[units: Participants]
 		   
Any local solicited symptom post-dose 1     174     169  
Any pain     167     151  
Grade 3 pain (prevented activities)     1     4  
Any redness (> 0 mm)     43     43  
Grade 3 redness (> 30 mm)     1     3  
Any swelling (> 0 mm)     39     41  
Grade 3 swelling (> 30 mm)     4     7  
Any systemic solicited symptom post-dose 1     144     126  
Any fever (≥ 99.5°F ax or ≥ 100.4°F oral)     16     10  
Grade 3 fever (> 103.1°F ax or > 104.0°F oral)     2     0  
Any nausea/vomiting     23     24  
Grade 3 nausea/vomiting (prevented activities)     3     3  
Any diarrhea     20     25  
Grade 3 diarrhea (prevented activities)     1     0  
Any malaise     55     51  
Grade 3 malaise (prevented activities)     10     3  
Any headache     69     66  
Grade 3 headache (prevented activities)     7     3  
Any myalgia     101     93  
Grade 3 myalgia (prevented activities)     5     4  

No statistical analysis provided for Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C



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

Measure Type Secondary
Measure Title Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Measure Description UAE stands for Unsolicited Adverse Events
Time Frame 30 days after each vaccination  
Safety Issue Yes  

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.
Safety population

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.

Measured Values
    Afluria Cohort A     Afluria Cohort B     Afluria Cohort C     Fluzone Cohort A     Fluzone Cohort B     Fluzone Cohort C  
Number of Participants Analyzed  
[units: participants]
 		  229     252     254     228     255     250  
Frequency and Intensity of Unsolicited Adverse Events (UAEs)  
[units: Participants]
 		           
Any     123     100     88     112     84     70  
Grade 3     28     25     17     24     22     16  
Any related     37     24     20     16     18     14  

No statistical analysis provided for Frequency and Intensity of Unsolicited Adverse Events (UAEs)



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

Measure Type Secondary
Measure Title New Onset of Chronic Illnesses (NOCIs)
Measure Description New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Time Frame 6 months after last study vaccination  
Safety Issue Yes  

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.
Safety population

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.

Measured Values
    Afluria Cohort A     Afluria Cohort B     Afluria Cohort C     Fluzone Cohort A     Fluzone Cohort B     Fluzone Cohort C  
Number of Participants Analyzed  
[units: participants]
 		  229     252     254     228     255     250  
New Onset of Chronic Illnesses (NOCIs)  
[units: Participants]
 		           
Total number of participants with NOCI     2     0     2     2     1     0  
Number of participants with related NOCI     0     0     0     0     0     0  
Asthma     1     0     2     1     0     0  
Von Willebrand's Disease     1     0     0     0     0     0  
Eczema     0     0     0     1     0     0  
Attention deficit disorder     0     0     0     0     1     0  

No statistical analysis provided for New Onset of Chronic Illnesses (NOCIs)



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

Measure Type Secondary
Measure Title Serious Adverse Events (SAEs)
Measure Description No text entered.
Time Frame 6 months after last study vaccination  
Safety Issue Yes  

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.
Safety Population

Reporting Groups
  Description
Afluria Cohort A Age 6 months to < 3 years
Afluria Cohort B Age 3 to < 9 years
Afluria Cohort C Age 9 to < 18 years
Fluzone Cohort A Age 6 months to < 3 years
Fluzone Cohort B Age 3 to < 9 years
Fluzone Cohort C Age 3 to < 9 years

Measured Values
    Afluria Cohort A     Afluria Cohort B     Afluria Cohort C     Fluzone Cohort A     Fluzone Cohort B     Fluzone Cohort C  
Number of Participants Analyzed  
[units: participants]
 		  229     252     254     228     255     250  
Serious Adverse Events (SAEs)  
[units: Participants]
 		           
Number of participants with SAEs     4     2     2     4     0     0  
Number of participants with related SAEs     0     0     0     0     0     0  

No statistical analysis provided for Serious Adverse Events (SAEs)



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

Measure Type Secondary
Measure Title Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Measure Description No text entered.
Time Frame 7 days after each vaccination  
Safety Issue Yes  

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.
Safety population

Reporting Groups
  Description
Afluria Cohort A Age 6 months to < 3 years
Fluzone Cohort A Age 6 months to < 3 years

Measured Values
    Afluria Cohort A     Fluzone Cohort A  
Number of Participants Analyzed  
[units: participants]
 		  229     228  
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)  
[units: Days]
Mean ± Standard Deviation 		   
Any pain post-dose 1     1.57  ± 0.952     1.43  ± 0.728  
Any redness (> 0 mm)     2.09  ± 1.405     2.22  ± 1.939  
Any swelling (> 0 mm)     3.13  ± 2.930     2.00  ± 1.569  
Any pain post-dose 2     1.54  ± 0.793     1.45  ± 0.739  
Any redness (> 0 mm)     1.80  ± 1.014     1.73  ± 0.935  
Any swelling (> 0 mm)     1.67  ± 0.707     1.57  ± 0.787  
Any fever dose 1 (≥ 99.5°F ax or ≥ 100.4°F oral)     1.38  ± 0.869     1.49  ± 0.989  
Any nausea/vomiting     1.42  ± 1.119     1.29  ± 1.042  
Any diarrhea     2.23  ± 2.157     2.16  ± 2.189  
Any loss of appetite     2.61  ± 3.695     2.85  ± 4.458  
Any irritability     2.26  ± 2.858     2.64  ± 3.825  
Any fever dose 2 (≥ 99.5°F ax or ≥ 100.4°F oral)     1.80  ± 1.146     1.81  ± 1.559  
Any nausea/vomiting     2.50  ± 1.291     1.78  ± 1.093  
Any diarrhea     2.83  ± 2.431     2.44  ± 2.332  
Any loss of appetite     2.47  ± 1.586     2.33  ± 1.447  
Any irritability     2.31  ± 1.732     2.17  ± 1.543  

No statistical analysis provided for Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)



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

Measure Type Secondary
Measure Title Duration of Local and Systemic Solicited Symptoms, Cohort B
Measure Description No text entered.
Time Frame 7 days after each vaccination  
Safety Issue Yes  

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.
Safety population

Reporting Groups
  Description
Afluria Cohort B Age 3 to < 9 years
Fluzone Cohort B Age 3 to < 9 years

Measured Values
    Afluria Cohort B     Fluzone Cohort B  
Number of Participants Analyzed  
[units: participants]
 		  252     255  
Duration of Local and Systemic Solicited Symptoms, Cohort B  
[units: Days]
Mean ± Standard Deviation 		   
Any pain post-dose 1     1.89  ± 1.138     1.89  ± 1.337  
Any redness (> 0 mm)     2.32  ± 1.621     2.10  ± 2.014  
Any swelling (> 0 mm)     2.39  ± 2.021     2.09  ± 1.273  
Any pain post-dose 2     1.96  ± 1.637     1.65  ± 0.775  
Any redness (> 0 mm)     2.40  ± 2.191     1.77  ± 1.235  
Any swelling (> 0 mm)     3.00  ± 2.160     1.69  ± 1.251  
Any fever dose 1 (≥ 99.5°F ax or ≥ 100.4°F oral)     1.45  ± 1.032     1.40  ± 0.707  
Any nausea/vomiting     1.27  ± 0.719     1.43  ± 1.165  
Any diarrhea     2.89  ± 4.988     1.44  ± 1.044  
Any malaise     1.86  ± 1.324     1.74  ± 1.094  
Any headache     1.50  ± 0.770     1.66  ± 1.328  
Any myalgia     1.72  ± 1.007     1.63  ± 1.009  
Any fever dose 2 (≥ 99.5°F ax or ≥ 100.4°F oral)     1.50  ± 0.577     1.00  ± 0.000  
Any nausea/vomiting     1.00  ± 0.000     1.20  ± 0.447  
Any diarrhea     1.33  ± 0.816     2.20  ± 0.447  
Any malaise     1.83  ± 1.602     1.71  ± 0.756  
Any headache     1.00  ± 0.000     1.30  ± 0.483  
Any myalgia     2.00  ± 1.528     1.54  ± 0.660  

No statistical analysis provided for Duration of Local and Systemic Solicited Symptoms, Cohort B



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

Measure Type Secondary
Measure Title Duration of Local and Systemic Solicited Symptoms, Cohort C
Measure Description No text entered.
Time Frame 7 days after vaccination  
Safety Issue Yes  

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.
Safety population

Reporting Groups
  Description
Afluria Cohort C Age 9 to < 18 years
Fluzone Cohort C Age 9 to < 18 years

Measured Values
    Afluria Cohort C     Fluzone Cohort C  
Number of Participants Analyzed  
[units: participants]
 		  254     250  
Duration of Local and Systemic Solicited Symptoms, Cohort C  
[units: Days]
Mean ± Standard Deviation 		   
Any pain     1.96  ± 1.087     1.99  ± 1.136  
Any redness (> 0 mm)     2.02  ± 1.669     2.38  ± 1.992  
Any swelling (> 0 mm)     1.75  ± 1.171     2.38  ± 1.724  
Any fever (≥ 99.5°F ax or ≥ 100.4°F oral)     1.82  ± 1.590     3.10  ± 2.644  
Any nausea/vomiting     1.36  ± 0.569     2.88  ± 3.791  
Any diarrhea     1.18  ± 0.395     1.36  ± 0.911  
Any malaise     2.09  ± 1.487     2.82  ± 3.449  
Any headache     1.77  ± 1.443     2.05  ± 1.945  
Any myalgia     1.76  ± 1.100     2.11  ± 1.491  

No statistical analysis provided for Duration of Local and Systemic Solicited Symptoms, Cohort C




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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.


Limitations and Caveats
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
No text entered.  


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