Trial Outcomes & Findings for Sanofi Pasteur, TIV + H1N1, Pediatric Population (NCT NCT00943202)

Results Overview

Blood was collected from participants 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 post first H1N1 vaccination 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. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

531 participants

Primary outcome timeframe

Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Results posted on

2013-04-22

Participant Flow

Participants were healthy males and females, age 6 months to 17 years, recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 20AUG2009 and 21SEP2009.

Participant milestones

Participant milestones
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Overall Study STARTED	133	133	133	132
Overall Study COMPLETED	132	131	133	131
Overall Study NOT COMPLETED	1	2	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sanofi Pasteur, TIV + H1N1, Pediatric Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=133 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=133 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=133 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=132 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.	Total n=531 Participants Total of all reporting groups
Age, Categorical <=18 years	133 Participants n=5 Participants	133 Participants n=7 Participants	133 Participants n=5 Participants	132 Participants n=4 Participants	531 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	8.0 years STANDARD_DEVIATION 5.0 • n=5 Participants	8.2 years STANDARD_DEVIATION 5.3 • n=7 Participants	7.9 years STANDARD_DEVIATION 5.3 • n=5 Participants	8.5 years STANDARD_DEVIATION 5.0 • n=4 Participants	8.1 years STANDARD_DEVIATION 5.1 • n=21 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	71 Participants n=7 Participants	57 Participants n=5 Participants	57 Participants n=4 Participants	253 Participants n=21 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	62 Participants n=7 Participants	76 Participants n=5 Participants	75 Participants n=4 Participants	278 Participants n=21 Participants
Region of Enrollment United States	133 participants n=5 Participants	133 participants n=7 Participants	133 participants n=5 Participants	132 participants n=4 Participants	531 participants n=21 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 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 post first H1N1 vaccination 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. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=30 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=33 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=26 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 Months to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	10 Participants	6 Participants	5 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 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 post first H1N1 vaccination 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. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=47 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=49 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=45 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=50 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	20 Participants	21 Participants	19 Participants	20 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 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 post first H1N1 vaccination 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. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=48 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=46 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	46 Participants	39 Participants	41 Participants	48 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=33 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=28 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination Lethargy	8 Participants	6 Participants	8 Participants	3 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination Irritability	18 Participants	15 Participants	16 Participants	9 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination Decreased appetite	6 Participants	5 Participants	9 Participants	5 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Nausea	8 Participants	4 Participants	6 Participants	4 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Decreased general activity	12 Participants	6 Participants	14 Participants	5 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Feverishness	8 Participants	8 Participants	10 Participants	1 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Myalgia	5 Participants	4 Participants	11 Participants	5 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Headache	13 Participants	8 Participants	12 Participants	5 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post 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, malaise, 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=49 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=53 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Feverishness	4 Participants	7 Participants	5 Participants	5 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Malaise	14 Participants	13 Participants	10 Participants	11 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Myalgia	8 Participants	9 Participants	5 Participants	5 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Headache	11 Participants	17 Participants	11 Participants	12 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Nausea	4 Participants	9 Participants	7 Participants	5 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination Decreased general activity	5 Participants	10 Participants	6 Participants	7 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=32 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=28 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Irritability	11 Participants	15 Participants	13 Participants	11 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Decreased appetite	5 Participants	5 Participants	3 Participants	7 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Lethargy	6 Participants	2 Participants	4 Participants	5 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=47 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=48 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Feverishness	2 Participants	3 Participants	4 Participants	2 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Myalgia	5 Participants	2 Participants	3 Participants	3 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Headache	5 Participants	2 Participants	4 Participants	2 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Nausea	3 Participants	3 Participants	5 Participants	0 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Decreased general activity	3 Participants	6 Participants	6 Participants	4 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post 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, malaise, 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=48 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=52 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Feverishness	6 Participants	5 Participants	4 Participants	5 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Malaise	9 Participants	9 Participants	4 Participants	2 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Myalgia	7 Participants	1 Participants	5 Participants	5 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Headache	15 Participants	8 Participants	11 Participants	8 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Nausea	11 Participants	5 Participants	3 Participants	3 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Decreased general activity	7 Participants	6 Participants	4 Participants	4 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post third vaccination

Population: All participants receiving the third 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. Groups 1 and 4 only had a third vaccination day.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=32 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=28 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Irritability	9 Participants	8 Participants	—	—
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Decreased appetite	5 Participants	2 Participants	—	—
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Lethargy	6 Participants	2 Participants	—	—

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post third vaccination

Population: All participants receiving the third 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. Groups 1 and 4 only had a third vaccination day.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Feverishness	1 Participants	1 Participants	—	—
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Myalgia	2 Participants	1 Participants	—	—
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Headache	2 Participants	3 Participants	—	—
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Nausea	1 Participants	1 Participants	—	—
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Decreased general activity	3 Participants	2 Participants	—	—

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post third vaccination

Population: All participants receiving the third 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, malaise, 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. Groups 1 and 4 only had a third vaccination day.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=52 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Feverishness	5 Participants	1 Participants	—	—
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Malaise	8 Participants	4 Participants	—	—
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Myalgia	3 Participants	4 Participants	—	—
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Headache	9 Participants	7 Participants	—	—
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Nausea	4 Participants	3 Participants	—	—
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Decreased general activity	5 Participants	4 Participants	—	—

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post 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 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=33 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=28 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the First Vaccination Fever	2 Participants	2 Participants	3 Participants	3 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the First Vaccination Vomiting	1 Participants	2 Participants	3 Participants	2 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post 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 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination Fever	4 Participants	1 Participants	5 Participants	1 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination Vomiting	9 Participants	0 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post 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 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=49 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=53 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination Fever	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination Vomiting	0 Participants	2 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second vaccination

Population: All participants receiving the second vaccination are included in the safety cohort. One Group 2 participant did not report temperatures. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.

Participants' 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=32 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=28 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination Fever	3 Participants	1 Participants	4 Participants	1 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination Vomiting	0 Participants	2 Participants	3 Participants	2 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post 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 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=47 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=48 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination Fever	1 Participants	1 Participants	2 Participants	2 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination Vomiting	4 Participants	1 Participants	5 Participants	1 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second vaccination

Population: All participants receiving the second vaccination are included in the safety cohort. One Group 3 participant did not report temperatures. 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 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=48 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=52 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination Fever	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination Vomiting	3 Participants	1 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post third vaccination

Population: All participants receiving the third 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 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. Groups 1 and 4 only had a third vaccination day.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=32 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=28 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination Fever	3 Participants	2 Participants	—	—
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination Vomiting	2 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post third vaccination

Population: All participants receiving the third 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 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. Groups 1 and 4 only had a third vaccination day.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination Fever	0 Participants	0 Participants	—	—
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination Vomiting	1 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post third vaccination

Population: All participants receiving the third 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 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. Groups 1 and 4 only had a third vaccination day.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=52 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination Fever	0 Participants	1 Participants	—	—
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination Vomiting	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first H1N1 vaccination

Population: All participants receiving the first H1N1 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 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. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=33 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=28 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Pain	1 Participants	6 Participants	8 Participants	1 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Tenderness	11 Participants	11 Participants	15 Participants	9 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Swelling	4 Participants	10 Participants	5 Participants	7 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first H1N1 vaccination

Population: All participants receiving the first H1N1 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 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. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Pain	15 Participants	13 Participants	13 Participants	14 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Tenderness	16 Participants	26 Participants	21 Participants	21 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Swelling	11 Participants	10 Participants	9 Participants	8 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first H1N1 vaccination

Population: All participants receiving the first H1N1 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 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. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=49 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=52 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Pain	16 Participants	10 Participants	13 Participants	14 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Tenderness	22 Participants	11 Participants	18 Participants	15 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Swelling	5 Participants	3 Participants	6 Participants	6 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second H1N1 vaccination

Population: All participants receiving the second H1N1 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 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. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=32 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=28 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Pain	4 Participants	5 Participants	10 Participants	1 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Tenderness	8 Participants	7 Participants	18 Participants	9 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Swelling	6 Participants	5 Participants	6 Participants	4 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second H1N1 vaccination

Population: All participants receiving the second H1N1 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 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. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=47 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=48 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Pain	16 Participants	14 Participants	17 Participants	10 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Tenderness	20 Participants	23 Participants	20 Participants	21 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Swelling	8 Participants	8 Participants	9 Participants	9 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second H1N1 vaccination

Population: All participants receiving the second H1N1 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 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. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=48 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=52 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Pain	16 Participants	14 Participants	19 Participants	7 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Tenderness	22 Participants	16 Participants	23 Participants	15 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Swelling	4 Participants	5 Participants	9 Participants	4 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post TIV vaccination

Population: All participants receiving the TIV 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 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. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=32 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=33 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=28 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the TIV Vaccination Pain	3 Participants	6 Participants	7 Participants	1 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the TIV Vaccination Tenderness	8 Participants	10 Participants	15 Participants	5 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the TIV Vaccination Swelling	6 Participants	9 Participants	7 Participants	7 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post TIV vaccination

Population: All participants receiving the TIV 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 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. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=48 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination Pain	21 Participants	14 Participants	20 Participants	24 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination Tenderness	21 Participants	23 Participants	23 Participants	30 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination Swelling	7 Participants	8 Participants	8 Participants	16 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post TIV vaccination

Population: All participants receiving the TIV 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 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. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=49 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=53 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination Pain	25 Participants	27 Participants	26 Participants	26 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination Tenderness	27 Participants	28 Participants	32 Participants	34 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination Swelling	4 Participants	8 Participants	9 Participants	11 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first H1N1 vaccination

Population: All participants receiving the first H1N1 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 local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. 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. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=33 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=28 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination Redness	14 Participants	15 Participants	15 Participants	17 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination Swelling	4 Participants	10 Participants	5 Participants	9 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first H1N1 vaccination

Population: All participants receiving the first H1N1 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 local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination Redness	19 Participants	18 Participants	23 Participants	16 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination Swelling	12 Participants	12 Participants	9 Participants	8 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first H1N1 vaccination

Population: All participants receiving the first H1N1 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 local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=49 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=52 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination Redness	8 Participants	6 Participants	15 Participants	14 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination Swelling	6 Participants	4 Participants	6 Participants	6 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second H1N1 vaccination

Population: All participants receiving the second H1N1 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 local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. 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. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=32 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=28 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination Redness	14 Participants	17 Participants	14 Participants	14 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination Swelling	7 Participants	8 Participants	9 Participants	5 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second H1N1 vaccination

Population: All participants receiving the second H1N1 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 local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=47 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=48 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination Redness	12 Participants	19 Participants	22 Participants	18 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination Swelling	8 Participants	9 Participants	11 Participants	10 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second H1N1 vaccination

Population: All participants receiving the second H1N1 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 local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=48 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=52 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination Redness	15 Participants	13 Participants	14 Participants	13 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination Swelling	5 Participants	5 Participants	9 Participants	4 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post TIV vaccination

Population: All participants receiving the TIV 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 local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. 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. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=32 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=33 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=28 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the TIV Vaccination Redness	17 Participants	14 Participants	16 Participants	17 Participants
Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the TIV Vaccination Swelling	6 Participants	9 Participants	9 Participants	9 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post TIV vaccination

Population: All participants receiving the TIV 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 local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=51 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=48 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination Redness	16 Participants	19 Participants	20 Participants	18 Participants
Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination Swelling	8 Participants	14 Participants	10 Participants	10 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post TIV vaccination

Population: All participants receiving the TIV 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 local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=49 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=53 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination Redness	15 Participants	10 Participants	15 Participants	15 Participants
Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination Swelling	4 Participants	8 Participants	9 Participants	11 Participants

PRIMARY outcome

Timeframe: Day 0 through 180 days after the last vaccination

Population: All participants receiving at least one 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; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=133 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=133 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=133 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=132 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 21 after first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=35 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=32 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=33 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=26 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 Months to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	10 Participants	6 Participants	5 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 21 after first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=47 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=49 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=45 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=50 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	20 Participants	21 Participants	19 Participants	22 Participants

PRIMARY outcome

Timeframe: Day 21 after first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. 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	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=48 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=46 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=51 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	47 Participants	40 Participants	45 Participants	48 Participants

SECONDARY outcome

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

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Two participants were excluded due to receipt of non-study vaccines and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. 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 titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=29 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=30 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=30 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=25 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV B antigen	10 Participants	7 Participants	4 Participants	4 Participants
Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H1 antigen	23 Participants	14 Participants	19 Participants	18 Participants
Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H3 antigen	25 Participants	18 Participants	25 Participants	23 Participants

SECONDARY outcome

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

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of non-study vaccine, 3 due to Influenza-like illness, and 1 due to H1N1 infection. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. 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 titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=38 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=47 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=45 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=47 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H1 antigen	27 Participants	20 Participants	16 Participants	24 Participants
Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H3 antigen	30 Participants	30 Participants	23 Participants	29 Participants
Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV B antigen	26 Participants	19 Participants	21 Participants	21 Participants

SECONDARY outcome

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

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. 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 titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=46 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=47 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=50 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H1 antigen	35 Participants	28 Participants	24 Participants	33 Participants
Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H3 antigen	34 Participants	33 Participants	28 Participants	30 Participants
Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV B antigen	36 Participants	22 Participants	25 Participants	32 Participants

SECONDARY outcome

Timeframe: Day 21 after last vaccination

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Two participants were excluded due to receipt of non-study vaccines and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=29 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=30 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=30 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=25 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H1 antigen	29 Participants	30 Participants	29 Participants	24 Participants
Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H3 antigen	29 Participants	30 Participants	29 Participants	25 Participants
Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV B antigen	10 Participants	9 Participants	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 21 after last vaccination

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of non-study vaccine, 3 due to Influenza-like illness, and 1 due to H1N1 infection. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=38 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=47 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=45 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=47 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H1 antigen	38 Participants	43 Participants	44 Participants	47 Participants
Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H3 antigen	38 Participants	43 Participants	44 Participants	47 Participants
Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV B antigen	32 Participants	31 Participants	33 Participants	34 Participants

SECONDARY outcome

Timeframe: Day 21 after last vaccination

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=46 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=47 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=50 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H1 antigen	49 Participants	46 Participants	46 Participants	50 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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H3 antigen	49 Participants	46 Participants	46 Participants	50 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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV B antigen	47 Participants	35 Participants	40 Participants	47 Participants

SECONDARY outcome

Timeframe: Day 21 after the second H1N1 vaccination

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=30 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=31 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=31 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=26 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	23 Participants	24 Participants	26 Participants	19 Participants

SECONDARY outcome

Timeframe: Day 21 after the second H1N1 vaccination

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=44 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=47 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=45 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=47 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	38 Participants	37 Participants	36 Participants	37 Participants

SECONDARY outcome

Timeframe: Day 21 after the second H1N1 vaccination

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. This outcome restricts to age stratum.

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=46 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=47 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=50 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	49 Participants	42 Participants	47 Participants	50 Participants

SECONDARY outcome

Timeframe: Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 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 post second H1N1 vaccination 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. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=30 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=30 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=31 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=26 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	23 Participants	23 Participants	26 Participants	19 Participants

SECONDARY outcome

Timeframe: Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 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 post second H1N1 vaccination 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. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=44 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=47 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=45 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=47 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	38 Participants	37 Participants	36 Participants	35 Participants

SECONDARY outcome

Timeframe: Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 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 post second H1N1 vaccination 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. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.

Outcome measures

Outcome measures
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=49 Participants Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=46 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=47 Participants Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=50 Participants Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	48 Participants	41 Participants	43 Participants	50 Participants

Adverse Events

Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV

Serious events: 0 serious events

Other events: 124 other events

Deaths: 0 deaths

Group 2: Day 0-H1N1+TIV; Day 21-H1N1

Serious events: 3 serious events

Other events: 125 other events

Deaths: 0 deaths

Group 3: Day 0-H1N1; Day 21-H1N1+TIV

Serious events: 1 serious events

Other events: 124 other events

Deaths: 0 deaths

Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1

Serious events: 2 serious events

Other events: 125 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV n=133 participants at risk Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: Day 0-H1N1+TIV; Day 21-H1N1 n=133 participants at risk Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21	Group 3: Day 0-H1N1; Day 21-H1N1+TIV n=133 participants at risk Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21	Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 n=132 participants at risk Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Immune system disorders Anaphylactic reaction	0.00% 0/133 • 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% 0/133 • 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.	0.75% 1/133 • 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.	0.76% 1/132 • 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 Head injury	0.00% 0/133 • 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.	0.75% 1/133 • 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% 0/133 • 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% 0/132 • 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 Abscess	0.00% 0/133 • 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.	0.75% 1/133 • 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% 0/133 • 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% 0/132 • 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 Multiple fractures	0.00% 0/133 • 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.	0.75% 1/133 • 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% 0/133 • 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% 0/132 • 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.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/133 • 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% 0/133 • 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% 0/133 • 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.	0.76% 1/132 • 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

Sharon E. Frey, M.D.

Division of Infectious Diseases and Immunology, Saint Louis University Medical School

Phone: 314-977-5500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60