Sanofi Pasteur, TIV + H1N1, Pediatric Population

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00943202

First received: July 21, 2009

Last updated: April 11, 2013

Last verified: December 2010

History of Changes

Results First Received: April 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Influenza
Interventions:	Biological: Inactivated H1N1 Vaccine Biological: Trivalent Inactivated Influenza Vaccine

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 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

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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
Number of Participants [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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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40. Primary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Measure Description	Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. 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 H1N1 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 all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. This outcome restricts to 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
Number of Participants Analyzed [units: participants]	49	46	47	50
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 [units: Participants]	49	42	47	50

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 H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine

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

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

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

Results Point of Contact:

Name/Title: Sharon E. Frey, M.D.
Organization: Division of Infectious Diseases and Immunology, Saint Louis University Medical School
phone: 314-977-5500
e-mail: freyse@slu.edu

Publications of Results:

Frey SE, Bernstein DI, Gerber MA, Keyserling HL, Munoz FM, Winokur PL, Turley CB, Rupp RE, Hill H, Wolff M, Noah DL, Ross AC, Cress G, Belshe RB. Safety and immune responses in children after concurrent or sequential 2009 H1N1 and 2009-2010 seasonal trivalent influenza vaccinations. J Infect Dis. 2012 Sep 15;206(6):828-37. doi: 10.1093/infdis/jis445. Epub 2012 Jul 16.

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00943202 History of Changes
Other Study ID Numbers:	09-0047, N01AI80003C
Study First Received:	July 21, 2009
Results First Received:	April 28, 2011
Last Updated:	April 11, 2013
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration United States: Federal Government

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