Trial Outcomes & Findings for Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels (NCT NCT00944073)

Results Overview

Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

583 participants

Primary outcome timeframe

Day 0-7 after first vaccination

Results posted on

2015-02-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	292	291
Overall Study COMPLETED	287	287
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	15 mcg H1N1 Vaccine n=292 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=291 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	Total n=583 Participants Total of all reporting groups
Age, Categorical <=18 years	292 Participants n=5 Participants	291 Participants n=7 Participants	583 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	7.6 years STANDARD_DEVIATION 5.5 • n=5 Participants	7.3 years STANDARD_DEVIATION 5.2 • n=7 Participants	7.5 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	137 Participants n=7 Participants	266 Participants n=5 Participants
Sex: Female, Male Male	163 Participants n=5 Participants	154 Participants n=7 Participants	317 Participants n=5 Participants
Region of Enrollment United States	292 participants n=5 Participants	291 participants n=7 Participants	583 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0-7 after first vaccination

Population: All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=292 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=291 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination Pain	60 Participants	69 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination Tenderness	102 Participants	98 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination Swelling	38 Participants	30 Participants

PRIMARY outcome

Timeframe: Day 0-7 after second vaccination

Population: All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.

Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=286 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=285 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination Pain	65 Participants	75 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination Tenderness	90 Participants	98 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination Swelling	28 Participants	31 Participants

PRIMARY outcome

Timeframe: Day 0-7 after first vaccination

Population: All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=292 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=291 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination Swelling	34 Participants	30 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination Redness	54 Participants	60 Participants

PRIMARY outcome

Timeframe: Day 0-7 after second vaccination

Population: All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.

Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=286 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=285 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination Swelling	27 Participants	30 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination Redness	60 Participants	62 Participants

PRIMARY outcome

Timeframe: Day 0-7 after first vaccination

Population: All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=292 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=291 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination Fever	11 Participants	8 Participants
Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination Vomiting	8 Participants	13 Participants

PRIMARY outcome

Timeframe: Day 0-7 after second vaccination

Population: All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.

Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=286 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=285 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination Fever	6 Participants	7 Participants
Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination Vomiting	15 Participants	7 Participants

PRIMARY outcome

Timeframe: Day 0-7 after first vaccination

Population: 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.

Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=94 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=98 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination Irritability	34 Participants	42 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination Decreased appetite	20 Participants	15 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination Lethargy	15 Participants	15 Participants

PRIMARY outcome

Timeframe: Day 0-7 after second vaccination

Population: All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=92 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=96 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Irritability	35 Participants	38 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Decreased appetite	15 Participants	11 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Lethargy	9 Participants	16 Participants

PRIMARY outcome

Timeframe: Day 0-7 after first vaccination

Population: 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.

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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=100 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=97 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Feverishness	6 Participants	4 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Myalgia	1 Participants	5 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Headache	13 Participants	12 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Nausea	4 Participants	6 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Decreased general activity	10 Participants	14 Participants

PRIMARY outcome

Timeframe: Day 0-7 after second vaccination

Population: All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=99 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=97 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Feverishness	6 Participants	6 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Myalgia	1 Participants	6 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Headache	7 Participants	10 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Nausea	4 Participants	9 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Decreased general activity	5 Participants	7 Participants

PRIMARY outcome

Timeframe: Day 0-7 after first vaccination

Population: 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.

Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=98 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=96 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Feverishness	6 Participants	9 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Myalgia	18 Participants	15 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Headache	27 Participants	24 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Nausea	10 Participants	13 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Decreased general activity	13 Participants	11 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Malaise	9 Participants	27 Participants

PRIMARY outcome

Timeframe: Day 0-7 after second vaccination

Population: All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=95 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=92 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Feverishness	7 Participants	6 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Myalgia	10 Participants	9 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Headache	23 Participants	22 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Nausea	10 Participants	8 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Decreased general activity	10 Participants	12 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Malaise	13 Participants	9 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 180 after last vaccination

Population: All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=292 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=291 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0

Population: All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=94 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=97 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	4 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 8-10

Population: All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=21 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=21 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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 8-10 Following a Single Dose of H1N1 Vaccine	5 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 21

Population: Participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.

Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=70 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=75 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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 21 Following a Single Dose of H1N1 Vaccine	14 Participants	16 Participants

PRIMARY outcome

Timeframe: Day 0

Population: All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=99 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=96 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	6 Participants	4 Participants

PRIMARY outcome

Timeframe: Day 8-10

Population: All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=32 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=32 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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 8-10 Following a Single Dose of H1N1 Vaccine	10 Participants	11 Participants

PRIMARY outcome

Timeframe: Day 21

Population: All participants with blood collected at the timepoint within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=68 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=65 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	32 Participants	28 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and Days 8-10 and 21 after first vaccination

Population: All participants with blood collected at baseline and with at least one evaluable time point after vaccination are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants prior to vaccination and at Days 8-10 and 21 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=98 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=96 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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 Day 0	11 Participants	10 Participants
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 Day 8-10	82 Participants	86 Participants
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 Day 21	91 Participants	88 Participants

PRIMARY outcome

Timeframe: Day 0 prior to and Day 8-10 after first vaccination

Population: All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=21 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=21 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	4 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 0 prior to and Day 21 after first vaccination

Population: Participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.

Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=70 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=75 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	14 Participants	15 Participants

PRIMARY outcome

Timeframe: Day 0 prior to and Day 8-10 after first vaccination

Population: All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=31 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=32 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	10 Participants	11 Participants

PRIMARY outcome

Timeframe: Day 0 prior to and Day 21 after first vaccination

Population: All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=68 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=65 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	32 Participants	27 Participants

PRIMARY outcome

Timeframe: Day 0 prior to and Days 8-10 and 21 after first vaccination

Population: All participants with blood collected at the timepoints are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 or Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 or Day 21 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=98 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=96 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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 Day 8-10	78 Participants	85 Participants
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 Day 21	88 Participants	87 Participants

SECONDARY outcome

Timeframe: Day 8-10 after the second vaccination

Population: All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=26 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=26 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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 8-10 Following the Second Dose of H1N1 Vaccine	25 Participants	25 Participants

SECONDARY outcome

Timeframe: Day 21 after the second vaccination

Population: Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=59 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=59 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	46 Participants	54 Participants

SECONDARY outcome

Timeframe: Day 8-10 after the second vaccination

Population: All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=31 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=32 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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 8-10 Following the Second Dose of H1N1 Vaccine	29 Participants	25 Participants

SECONDARY outcome

Timeframe: Day 21 after the second vaccination

Population: Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=67 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=62 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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 21 Following the Second Dose of H1N1 Vaccine	55 Participants	55 Participants

SECONDARY outcome

Timeframe: Day 8-10 after the second vaccination

Population: All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from all participants enrolled in this age stratum 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=93 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=91 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	90 Participants	90 Participants

SECONDARY outcome

Timeframe: Day 21 after the second vaccination

Population: All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from all participants enrolled in this age stratum 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.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=95 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=91 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	93 Participants	91 Participants

SECONDARY outcome

Timeframe: Day 0 prior to first vaccination and Day 8-10 after the second vaccination

Population: All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=26 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=26 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	24 Participants	25 Participants

SECONDARY outcome

Timeframe: Day 0 prior to first vaccination and Day 21 after the second vaccination

Population: Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=59 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=59 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	46 Participants	54 Participants

SECONDARY outcome

Timeframe: Day 0 prior to first vaccination and Day 8-10 after the second vaccination

Population: All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=30 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=32 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	28 Participants	25 Participants

SECONDARY outcome

Timeframe: Day 0 prior to first vaccination and Day 21 after the second vaccination

Population: Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=67 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=62 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	54 Participants	55 Participants

SECONDARY outcome

Timeframe: Day 0 prior to first vaccination and Day 8-10 after the second vaccination

Population: All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=93 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=91 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	87 Participants	89 Participants

SECONDARY outcome

Timeframe: Day 0 prior to first vaccination and Day 21 after the second vaccination

Population: All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	15 mcg H1N1 Vaccine n=95 Participants Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=91 Participants Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
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	91 Participants	90 Participants

Adverse Events

15 mcg H1N1 Vaccine

Serious events: 3 serious events

Other events: 253 other events

Deaths: 0 deaths

30 mcg H1N1 Vaccine

Serious events: 4 serious events

Other events: 255 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	15 mcg H1N1 Vaccine n=292 participants at risk Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.	30 mcg H1N1 Vaccine n=291 participants at risk Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Congenital, familial and genetic disorders Cleft palate	0.34% 1/292 • Number of events 1 • 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. 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.	0.00% 0/291 • 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. 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.34% 1/292 • Number of events 1 • 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. 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.	0.00% 0/291 • 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. 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.
Infections and infestations Gastroenteritis	0.34% 1/292 • Number of events 1 • 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. 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.	0.00% 0/291 • 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. 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.
Infections and infestations Bronchiolitis	0.00% 0/292 • 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. 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.	0.34% 1/291 • Number of events 1 • 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. 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.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/292 • 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. 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.	0.34% 1/291 • Number of events 1 • 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. 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.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/292 • 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. 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.	0.34% 1/291 • Number of events 1 • 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. 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.
Hepatobiliary disorders Cholecystitis	0.00% 0/292 • 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. 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.	0.34% 1/291 • Number of events 1 • 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. 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.

Other adverse events

Additional Information

Karen Kotloff, MD

Center for Vaccine Development, University of Maryland

Phone: 401-706-5328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60