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: May 10, 2012

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: Inactivated H1N1 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 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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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

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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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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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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
Number of 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:

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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 ]

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 ]

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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 ]

Show Outcome Measure 27

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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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
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.

Results Point of Contact:

Name/Title: Karen Kotloff, MD
Organization: Center for Vaccine Development, University of Maryland
phone: 401-706-5328
e-mail: kkotloff@medicine.umaryland.edu

No publications provided

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00944073 History of Changes
Other Study ID Numbers:	09-0054, N01AI80057C
Study First Received:	July 21, 2009
Results First Received:	March 17, 2011
Last Updated:	May 10, 2012
Health Authority:	United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board

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