Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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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
History of Changes
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were 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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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  
Number of Participants  
[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
  Show 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 ]
  Show Outcome Measure 1

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

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

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

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

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

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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

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 ]
  Hide Outcome Measure 9

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  
Number of 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 ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 12

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

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 ]
  Show Outcome Measure 14

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16

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 ]
  Show Outcome Measure 17

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 ]
  Show Outcome Measure 18

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 ]
  Show Outcome Measure 19

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 ]
  Show Outcome Measure 20

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 ]
  Show Outcome Measure 21

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 ]
  Show Outcome Measure 22

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 ]
  Show Outcome Measure 23

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 ]
  Show Outcome Measure 24

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 ]
  Show Outcome Measure 25

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 ]
  Show Outcome Measure 26

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 ]
  Show Outcome Measure 27

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 ]
  Show Outcome Measure 28

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 ]
  Show Outcome Measure 29

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 ]
  Show Outcome Measure 30

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 ]
  Show Outcome Measure 31

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 ]
  Show Outcome Measure 32

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 ]
  Show Outcome Measure 33

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 ]
  Show Outcome Measure 34

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 ]
  Show Outcome Measure 35

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 ]
  Show Outcome Measure 36

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 ]
  Show Outcome Measure 37


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


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