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Sanofi Pasteur, TIV + H1N1, Pediatric Population

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ClinicalTrials.gov Identifier: NCT00943202
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : May 26, 2011
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Inactivated H1N1 Vaccine
Biological: Trivalent Inactivated Influenza Vaccine

  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 males and females, age 6 months to 17 years, recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 20AUG2009 and 21SEP2009.

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
Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.

Participant Flow:   Overall Study
    Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV   Group 2: Day 0-H1N1+TIV; Day 21-H1N1   Group 3: Day 0-H1N1; Day 21-H1N1+TIV   Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
STARTED   133   133   133   132 
COMPLETED   132   131   133   131 
NOT COMPLETED   1   2   0   1 



  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
Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Total Total of all reporting groups

Baseline Measures
   Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV   Group 2: Day 0-H1N1+TIV; Day 21-H1N1   Group 3: Day 0-H1N1; Day 21-H1N1+TIV   Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 133   133   133   132   531 
Age 
[Units: Participants]
 		         
<=18 years   133   133   133   132   531 
Between 18 and 65 years   0   0   0   0   0 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 8.0  (5.0)   8.2  (5.3)   7.9  (5.3)   8.5  (5.0)   8.1  (5.1) 
Gender 
[Units: Participants]
 		         
Female   68   71   57   57   253 
Male   65   62   76   75   278 
Region of Enrollment 
[Units: Participants]
 		         
United States   133   133   133   132   531 


  Outcome Measures

1.  Primary:   Number of Participants Age 6 Months to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]
  Show Outcome Measure 3

4.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]
  Show Outcome Measure 4

5.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]
  Show Outcome Measure 5

6.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]
  Show Outcome Measure 6

7.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]
  Show Outcome Measure 7

8.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]
  Show Outcome Measure 8

9.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]
  Show Outcome Measure 9

10.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]
  Show Outcome Measure 10

11.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]
  Show Outcome Measure 11

12.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]
  Show Outcome Measure 12

13.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]
  Show Outcome Measure 13

14.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]
  Show Outcome Measure 14

15.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]
  Show Outcome Measure 15

16.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]
  Show Outcome Measure 16

17.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]
  Show Outcome Measure 17

18.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]
  Show Outcome Measure 18

19.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]
  Show Outcome Measure 19

20.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]
  Show Outcome Measure 20

21.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]
  Show Outcome Measure 21

22.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]
  Show Outcome Measure 22

23.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]
  Show Outcome Measure 23

24.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]
  Show Outcome Measure 24

25.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]
  Show Outcome Measure 25

26.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]
  Show Outcome Measure 26

27.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]
  Show Outcome Measure 27

28.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]
  Show Outcome Measure 28

29.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]
  Show Outcome Measure 29

30.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]
  Show Outcome Measure 30

31.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]
  Show Outcome Measure 31

32.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]
  Show Outcome Measure 32

33.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]
  Show Outcome Measure 33

34.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]
  Show Outcome Measure 34

35.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]
  Hide Outcome Measure 35

Measure Type Primary
Measure Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 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 (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.
Time Frame Within 8 days (Day 0-7) post second H1N1 vaccination  

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 H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

Reporting Groups
  Description
Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.

Measured Values
   Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV   Group 2: Day 0-H1N1+TIV; Day 21-H1N1   Group 3: Day 0-H1N1; Day 21-H1N1+TIV   Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 
Participants Analyzed 
[Units: Participants]
 		 47   51   48   51 
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination 
[Units: Participants]
 		       
Redness   12   19   22   18 
Swelling   8   9   11   10 

No statistical analysis provided for Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination



36.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]
  Show Outcome Measure 36

37.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]
  Show Outcome Measure 37

38.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]
  Show Outcome Measure 38

39.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]
  Show Outcome Measure 39

40.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through 180 days after the last vaccination ]
  Show Outcome Measure 40

41.  Primary:   Number of Participants Age 6 Months to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after first H1N1 vaccination ]
  Show Outcome Measure 41

42.  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 H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after first H1N1 vaccination ]
  Show Outcome Measure 42

43.  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 H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after first H1N1 vaccination ]
  Show Outcome Measure 43

44.  Secondary:   Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 0 prior to first vaccination and 21 days after last vaccination ]
  Show Outcome Measure 44

45.  Secondary:   Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 0 prior to first vaccination and Day 21 after last vaccination ]
  Show Outcome Measure 45

46.  Secondary:   Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 0 prior to first vaccination and Day 21 after last vaccination ]
  Show Outcome Measure 46

47.  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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 21 after last vaccination ]
  Show Outcome Measure 47

48.  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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 21 after last vaccination ]
  Show Outcome Measure 48

49.  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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 21 after last vaccination ]
  Show Outcome Measure 49

50.  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 H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second H1N1 vaccination ]
  Show Outcome Measure 50

51.  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 H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second H1N1 vaccination ]
  Show Outcome Measure 51

52.  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 H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second H1N1 vaccination ]
  Show Outcome Measure 52

53.  Secondary:   Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination ]
  Show Outcome Measure 53

54.  Secondary:   Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination ]
  Show Outcome Measure 54

55.  Secondary:   Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination ]
  Show Outcome Measure 55


  Serious Adverse Events


  Other Adverse Events


  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
Due to difficulties identifying children in the youngest age stratum who were previously primed, enrollment in this stratum was closed prior to meeting the planned number of participants.


  More Information