Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00944073
First received: July 21, 2009
Last updated: January 29, 2015
Last verified: March 2010
Results First Received: March 17, 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
Intervention: Biological: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A

  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 healthy pediatric males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 19AUG2009 and 9SEP2009.

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
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Participant Flow:   Overall Study
    15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine
STARTED   292   291 
COMPLETED   287   287 
NOT COMPLETED   5   4 



  Baseline Characteristics
  Hide Baseline Characteristics

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
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Total Total of all reporting groups

Baseline Measures
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine   Total 
Overall Participants Analyzed 
[Units: Participants]
 292   291   583 
Age 
[Units: Participants]
     
<=18 years   292   291   583 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 7.6  (5.5)   7.3  (5.2)   7.5  (5.3) 
Gender 
[Units: Participants]
     
Female   129   137   266 
Male   163   154   317 
Region of Enrollment 
[Units: Participants]
     
United States   292   291   583 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination
Measure Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Day 0-7 after first 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.
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 292   291 
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination 
[Units: Participants]
   
Pain   60   69 
Tenderness   102   98 
Swelling   38   30 

No statistical analysis provided for Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination



2.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination
Measure Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Day 0-7 after second 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.
All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 286   285 
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination 
[Units: Participants]
   
Pain   65   75 
Tenderness   90   98 
Swelling   28   31 

No statistical analysis provided for Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination



3.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination
Measure Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Time Frame Day 0-7 after first 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.
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 292   291 
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination 
[Units: Participants]
   
Swelling   34   30 
Redness   54   60 

No statistical analysis provided for Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination



4.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination
Measure Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Time Frame Day 0-7 after second 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.
All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 286   285 
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination 
[Units: Participants]
   
Swelling   27   30 
Redness   60   62 

No statistical analysis provided for Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination



5.  Primary:   Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination
Measure Description Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.
Time Frame Day 0-7 after first 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.
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 292   291 
Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination 
[Units: Participants]
   
Fever   11   8 
Vomiting   8   13 

No statistical analysis provided for Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination



6.  Primary:   Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination
Measure Description Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.
Time Frame Day 0-7 after second 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.
All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 286   285 
Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination 
[Units: Participants]
   
Fever   6   7 
Vomiting   15   7 

No statistical analysis provided for Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination



7.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Measure Description Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Day 0-7 after first 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.
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 94   98 
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination 
[Units: Participants]
   
Irritability   34   42 
Decreased appetite   20   15 
Lethargy   15   15 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination



8.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Measure Description Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Day 0-7 after second 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.
All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 92   96 
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination 
[Units: Participants]
   
Irritability   35   38 
Decreased appetite   15   11 
Lethargy   9   16 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination



9.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Measure Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Day 0-7 after first 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.
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 100   97 
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination 
[Units: Participants]
   
Feverishness   6   4 
Myalgia   1   5 
Headache   13   12 
Nausea   4   6 
Decreased general activity   10   14 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination



10.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Measure Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Day 0-7 after second 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.
All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 99   97 
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination 
[Units: Participants]
   
Feverishness   6   6 
Myalgia   1   6 
Headache   7   10 
Nausea   4   9 
Decreased general activity   5   7 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination



11.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Measure Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Day 0-7 after first 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.
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 98   96 
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination 
[Units: Participants]
   
Feverishness   6   9 
Myalgia   18   15 
Headache   27   24 
Nausea   10   13 
Decreased general activity   13   11 
Malaise   9   27 

No statistical analysis provided for Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination



12.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Measure Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Day 0-7 after second 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.
All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 95   92 
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination 
[Units: Participants]
   
Feverishness   7   6 
Myalgia   10   9 
Headache   23   22 
Nausea   10   8 
Decreased general activity   10   12 
Malaise   13   9 

No statistical analysis provided for Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination



13.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 180 after last vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Measure Description Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.
Time Frame Day 0 through Day 180 after last 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.
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 292   291 
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) 
[Units: Participants]
 0   0 

No statistical analysis provided for Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)



14.  Primary:   Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0   [ Time Frame: Day 0 ]

Measure Type Primary
Measure Title Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0
Measure Description Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 0  
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.
All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 94   97 
Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 
[Units: Participants]
 4   3 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0



15.  Primary:   Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 8-10 ]

Measure Type Primary
Measure Title Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine
Measure Description Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 8-10  
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.
All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 21   21 
Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine 
[Units: Participants]
 5   1 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine



16.  Primary:   Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 21 ]

Measure Type Primary
Measure Title Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine
Measure Description Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21  
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.
Participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 70   75 
Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine 
[Units: Participants]
 14   16 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine



17.  Primary:   Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0   [ Time Frame: Day 0 ]

Measure Type Primary
Measure Title Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0
Measure Description Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 0  
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.
All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 99   96 
Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 
[Units: Participants]
 6   4 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0



18.  Primary:   Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 8-10 ]

Measure Type Primary
Measure Title Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine
Measure Description Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 8-10  
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.
All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 32   32 
Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine 
[Units: Participants]
 10   11 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine



19.  Primary:   Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 21 ]

Measure Type Primary
Measure Title Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine
Measure Description Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21  
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.
All participants with blood collected at the timepoint within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 68   65 
Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine 
[Units: Participants]
 32   28 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine



20.  Primary:   Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and Days 8-10 and 21 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants prior to vaccination and at Days 8-10 and 21 for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 0 prior to vaccination and Days 8-10 and 21 after first 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.
All participants with blood collected at baseline and with at least one evaluable time point after vaccination are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 98   96 
Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine 
[Units: Participants]
   
Day 0   11   10 
Day 8-10   82   86 
Day 21   91   88 

No statistical analysis provided for Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine



21.  Primary:   Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine
Measure Description Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to and Day 8-10 after first 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.
All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 21   21 
Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine 
[Units: Participants]
 4   1 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine



22.  Primary:   Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 21 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine
Measure Description Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to and Day 21 after first 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.
Participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 70   75 
Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine 
[Units: Participants]
 14   15 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine



23.  Primary:   Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine
Measure Description Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to and Day 8-10 after first 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.
All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 31   32 
Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine 
[Units: Participants]
 10   11 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine



24.  Primary:   Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 21 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine
Measure Description Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to and Day 21 after first 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.
All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 68   65 
Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine 
[Units: Participants]
 32   27 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine



25.  Primary:   Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Days 8-10 and 21 after first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine
Measure Description Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 or Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 or Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to and Days 8-10 and 21 after first 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.
All participants with blood collected at the timepoints are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 98   96 
Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine 
[Units: Participants]
   
Day 8-10   78   85 
Day 21   88   87 

No statistical analysis provided for Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine



26.  Secondary:   Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8-10 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 8-10 after the second 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.
All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 26   26 
Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 25   25 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine



27.  Secondary:   Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after the second 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.
Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 59   59 
Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 46   54 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine



28.  Secondary:   Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8-10 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 8-10 after the second 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.
All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 31   32 
Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 29   25 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine



29.  Secondary:   Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after the second 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.
Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 67   62 
Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 55   55 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine



30.  Secondary:   Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8-10 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 8-10 after the second 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.
All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 93   91 
Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 90   90 

No statistical analysis provided for Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine



31.  Secondary:   Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after the second 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.
All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 95   91 
Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 93   91 

No statistical analysis provided for Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine



32.  Secondary:   Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to first vaccination and Day 8-10 after the second 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.
All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 26   26 
Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 24   25 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine



33.  Secondary:   Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to first vaccination and Day 21 after the second 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.
Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 59   59 
Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 46   54 

No statistical analysis provided for Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine



34.  Secondary:   Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to first vaccination and Day 8-10 after the second 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.
All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 30   32 
Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 28   25 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine



35.  Secondary:   Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to first vaccination and Day 21 after the second 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.
Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 67   62 
Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 54   55 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine



36.  Secondary:   Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to first vaccination and Day 8-10 after the second 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.
All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 93   91 
Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 87   89 

No statistical analysis provided for Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine



37.  Secondary:   Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to first vaccination and Day 21 after the second 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.
All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
15 mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Measured Values
   15 mcg H1N1 Vaccine   30 mcg H1N1 Vaccine 
Participants Analyzed 
[Units: Participants]
 95   91 
Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine 
[Units: Participants]
 91   90 

No statistical analysis provided for Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
To limit blood draws, the younger 2 age strata were assigned varying blood draw schedules and there were deviations from the schedules, reducing the size of subsets on the same schedule, such uniformity being optimal for longitudinal comparisons.


  More Information