Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels

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ClinicalTrials.gov Identifier: NCT00944073

Recruitment Status : Completed

First Posted : July 22, 2009

Results First Posted : April 13, 2011

Last Update Posted : February 18, 2015

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: Quadruple (Participant, Care Provider, 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
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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.
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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

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1. Primary:

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

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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5. Primary:

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

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6. Primary:

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

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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 ]

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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 ]

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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 ]

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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

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 ]

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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 ]

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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 ]

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13. Primary:

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

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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 ]

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15. Primary:

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16. Primary:

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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 ]

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18. Primary:

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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26. Secondary:

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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 ]

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28. Secondary:

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29. Secondary:

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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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