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; Intervention Model: Parallel Assignment; Masking: Double Blind (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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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 ]

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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 ]

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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 ]

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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 ]

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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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Time Frame	Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
Additional Description	For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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.

Other Adverse Events

	15 mcg H1N1 Vaccine	30 mcg H1N1 Vaccine
Total, Other (not including serious) Adverse Events
# participants affected / at risk	253/292 (86.64%)	255/291 (87.63%)
Gastrointestinal disorders
Diarrhoea ^* 1
# participants affected / at risk	15/292 (5.14%)	22/291 (7.56%)
# events	17	23
Nausea ^† 1 [4]
# participants affected / at risk	25/198 (12.63%)	33/198 (16.67%)
# events	28	36
Vomiting ^† 1
# participants affected / at risk	20/292 (6.85%)	18/291 (6.19%)
# events	23	20
General disorders
Pyrexia ^† 1
# participants affected / at risk	16/292 (5.48%)	14/291 (4.81%)
# events	17	15
Irritability ^† 1 [5]
# participants affected / at risk	48/94 (51.06%)	55/98 (56.12%)
# events	69	80
Feeling hot ^† 1 [4]
# participants affected / at risk	22/198 (11.11%)	21/193 (10.88%)
# events	25	25
Malaise ^† 1 [6]
# participants affected / at risk	18/98 (18.37%)	30/96 (31.25%)
# events	22	36
Decreased activity ^† 1 [4]
# participants affected / at risk	32/198 (16.16%)	39/193 (20.21%)
# events	38	44
Injection site pain ^† 1
# participants affected / at risk	101/292 (34.59%)	108/291 (37.11%)
# events	125	144
Tenderness ^† 1 [7]
# participants affected / at risk	135/292 (46.23%)	141/291 (48.45%)
# events	192	196
Injection site erythema ^† 1
# participants affected / at risk	89/292 (30.48%)	91/291 (31.27%)
# events	114	122
Injection site swelling (functional grading) ^† 1 [8]
# participants affected / at risk	54/292 (18.49%)	48/291 (16.49%)
# events	66	61
Injection site swelling (measured) ^† 1 [8]
# participants affected / at risk	50/292 (17.12%)	46/291 (15.81%)
# events	61	60
Infections and infestations
Nasopharyngitis ^* 1
# participants affected / at risk	24/292 (8.22%)	12/291 (4.12%)
# events	26	13
Upper respiratory tract infection ^* 1
# participants affected / at risk	27/292 (9.25%)	34/291 (11.68%)
# events	29	36
Metabolism and nutrition disorders
Decreased Appetite ^† 1 [5]
# participants affected / at risk	33/94 (35.11%)	22/98 (22.45%)
# events	35	26
Musculoskeletal and connective tissue disorders
Myalgia ^† 1 [4]
# participants affected / at risk	24/198 (12.12%)	32/193 (16.58%)
# events	30	35
Nervous system disorders
Lethargy ^† 1 [5]
# participants affected / at risk	21/94 (22.34%)	25/98 (25.51%)
# events	24	31
Headache ^† 1 [4]
# participants affected / at risk	52/198 (26.26%)	53/193 (27.46%)
# events	70	68
Respiratory, thoracic and mediastinal disorders
Cough ^* 1
# participants affected / at risk	14/292 (4.79%)	17/291 (5.84%)
# events	14	17
Nasal congestion ^* 1
# participants affected / at risk	7/292 (2.40%)	16/291 (5.50%)
# events	7	16
Rhinorrhoea ^* 1
# participants affected / at risk	18/292 (6.16%)	17/291 (5.84%)
# events	20	18

†	Events were collected by systematic assessment
*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (13.0)
[4]	Solicited from participants aged 36 months to 17 years only.
[5]	Solicited from participants aged 6 to less than 36 months only.
[6]	Solicited from participants aged 10 to 17 years only.
[7]	Tenderness was solicited as a reaction at the vaccination site.
[8]	Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.

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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