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Sanofi Pasteur, TIV + H1N1, Pediatric Population

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ClinicalTrials.gov Identifier: NCT00943202
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : May 26, 2011
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Inactivated H1N1 Vaccine
Biological: Trivalent Inactivated Influenza Vaccine
Enrollment 531

Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42 Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21 Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Period Title: Overall Study
Started 133 133 133 132
Completed 132 131 133 131
Not Completed 1 2 0 1
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Total
Hide Arm/Group Description Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42 Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21 Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21 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 of all reporting groups
Overall Number of Baseline Participants 133 133 133 132 531
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 133 participants 133 participants 132 participants 531 participants
<=18 years
133
 100.0%
133
 100.0%
133
 100.0%
132
 100.0%
531
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 133 participants 133 participants 132 participants 531 participants
8.0  (5.0) 8.2  (5.3) 7.9  (5.3) 8.5  (5.0) 8.1  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 133 participants 133 participants 132 participants 531 participants
Female
68
  51.1%
71
  53.4%
57
  42.9%
57
  43.2%
253
  47.6%
Male
65
  48.9%
62
  46.6%
76
  57.1%
75
  56.8%
278
  52.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 133 participants 133 participants 133 participants 132 participants 531 participants
133 133 133 132 531
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to vaccination and 21 days after the first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 35 30 33 26
Measure Type: Number
Unit of Measure: Participants
10 6 5 5
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to vaccination and 21 days after the first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 47 49 45 50
Measure Type: Number
Unit of Measure: Participants
20 21 19 20
3.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to vaccination and 21 days after the first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 48 46 51
Measure Type: Number
Unit of Measure: Participants
46 39 41 48
4.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 35 33 35 28
Measure Type: Number
Unit of Measure: Participants
Irritability 18 15 16 9
Decreased appetite 6 5 9 5
Lethargy 8 6 8 3
5.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Hide Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post first vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 51 49 51
Measure Type: Number
Unit of Measure: Participants
Feverishness 8 8 10 1
Myalgia 5 4 11 5
Headache 13 8 12 5
Nausea 8 4 6 4
Decreased general activity 12 6 14 5
6.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 49 49 53
Measure Type: Number
Unit of Measure: Participants
Feverishness 4 7 5 5
Malaise 14 13 10 11
Myalgia 8 9 5 5
Headache 11 17 11 12
Nausea 4 9 7 5
Decreased general activity 5 10 6 7
7.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 35 32 35 28
Measure Type: Number
Unit of Measure: Participants
Irritability 11 15 13 11
Decreased appetite 5 5 3 7
Lethargy 6 2 4 5
8.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Hide Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post second vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 47 51 48 51
Measure Type: Number
Unit of Measure: Participants
Feverishness 2 3 4 2
Myalgia 5 2 3 3
Headache 5 2 4 2
Nausea 3 3 5 0
Decreased general activity 3 6 6 4
9.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 48 49 52
Measure Type: Number
Unit of Measure: Participants
Feverishness 6 5 4 5
Malaise 9 9 4 2
Myalgia 7 1 5 5
Headache 15 8 11 8
Nausea 11 5 3 3
Decreased general activity 7 6 4 4
10.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Third Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post third vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
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 Number of Participants Analyzed 32 28
Measure Type: Number
Unit of Measure: Participants
Irritability 9 8
Decreased appetite 5 2
Lethargy 6 2
11.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination
Hide Description Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.
Time Frame Within 8 days (Day 0-7) post third vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
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 Number of Participants Analyzed 49 51
Measure Type: Number
Unit of Measure: Participants
Feverishness 1 1
Myalgia 2 1
Headache 2 3
Nausea 1 1
Decreased general activity 3 2
12.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post third vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
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 Number of Participants Analyzed 49 52
Measure Type: Number
Unit of Measure: Participants
Feverishness 5 1
Malaise 8 4
Myalgia 3 4
Headache 9 7
Nausea 4 3
Decreased general activity 5 4
13.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the First Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 35 33 35 28
Measure Type: Number
Unit of Measure: Participants
Fever 2 2 3 3
Vomiting 1 2 3 2
14.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 51 49 51
Measure Type: Number
Unit of Measure: Participants
Fever 4 1 5 1
Vomiting 9 0 3 1
15.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 49 49 53
Measure Type: Number
Unit of Measure: Participants
Fever 0 0 1 2
Vomiting 0 2 1 2
16.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 35 32 35 28
Measure Type: Number
Unit of Measure: Participants
Fever 3 1 4 1
Vomiting 0 2 3 2
17.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 47 51 48 51
Measure Type: Number
Unit of Measure: Participants
Fever 1 1 2 2
Vomiting 4 1 5 1
18.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 48 49 52
Measure Type: Number
Unit of Measure: Participants
Fever 2 0 1 1
Vomiting 3 1 1 2
19.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post third vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
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 Number of Participants Analyzed 32 28
Measure Type: Number
Unit of Measure: Participants
Fever 3 2
Vomiting 2 0
20.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post third vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
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 Number of Participants Analyzed 49 51
Measure Type: Number
Unit of Measure: Participants
Fever 0 0
Vomiting 1 0
21.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post third vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
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 Number of Participants Analyzed 49 52
Measure Type: Number
Unit of Measure: Participants
Fever 0 1
Vomiting 0 1
22.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 35 33 35 28
Measure Type: Number
Unit of Measure: Participants
Pain 1 6 8 1
Tenderness 11 11 15 9
Swelling 4 10 5 7
23.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 51 49 51
Measure Type: Number
Unit of Measure: Participants
Pain 15 13 13 14
Tenderness 16 26 21 21
Swelling 11 10 9 8
24.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 49 49 52
Measure Type: Number
Unit of Measure: Participants
Pain 16 10 13 14
Tenderness 22 11 18 15
Swelling 5 3 6 6
25.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 35 32 35 28
Measure Type: Number
Unit of Measure: Participants
Pain 4 5 10 1
Tenderness 8 7 18 9
Swelling 6 5 6 4
26.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 47 51 48 51
Measure Type: Number
Unit of Measure: Participants
Pain 16 14 17 10
Tenderness 20 23 20 21
Swelling 8 8 9 9
27.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 48 49 52
Measure Type: Number
Unit of Measure: Participants
Pain 16 14 19 7
Tenderness 22 16 23 15
Swelling 4 5 9 4
28.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the TIV Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post TIV vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 32 33 35 28
Measure Type: Number
Unit of Measure: Participants
Pain 3 6 7 1
Tenderness 8 10 15 5
Swelling 6 9 7 7
29.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post TIV vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 51 48 51
Measure Type: Number
Unit of Measure: Participants
Pain 21 14 20 24
Tenderness 21 23 23 30
Swelling 7 8 8 16
30.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post TIV vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 49 49 53
Measure Type: Number
Unit of Measure: Participants
Pain 25 27 26 26
Tenderness 27 28 32 34
Swelling 4 8 9 11
31.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 35 33 35 28
Measure Type: Number
Unit of Measure: Participants
Redness 14 15 15 17
Swelling 4 10 5 9
32.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 51 49 51
Measure Type: Number
Unit of Measure: Participants
Redness 19 18 23 16
Swelling 12 12 9 8
33.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 49 49 52
Measure Type: Number
Unit of Measure: Participants
Redness 8 6 15 14
Swelling 6 4 6 6
34.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 35 32 35 28
Measure Type: Number
Unit of Measure: Participants
Redness 14 17 14 14
Swelling 7 8 9 5
35.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 47 51 48 51
Measure Type: Number
Unit of Measure: Participants
Redness 12 19 22 18
Swelling 8 9 11 10
36.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 48 49 52
Measure Type: Number
Unit of Measure: Participants
Redness 15 13 14 13
Swelling 5 5 9 4
37.Primary Outcome
Title Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the TIV Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post TIV vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 32 33 35 28
Measure Type: Number
Unit of Measure: Participants
Redness 17 14 16 17
Swelling 6 9 9 9
38.Primary Outcome
Title Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post TIV vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 51 48 51
Measure Type: Number
Unit of Measure: Participants
Redness 16 19 20 18
Swelling 8 14 10 10
39.Primary Outcome
Title Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination
Hide Description 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.
Time Frame Within 8 days (Day 0-7) post TIV vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 49 49 53
Measure Type: Number
Unit of Measure: Participants
Redness 15 10 15 15
Swelling 4 8 9 11
40.Primary Outcome
Title Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Day 0 through 180 days after the last vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 133 133 133 132
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
41.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 21 after first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 35 32 33 26
Measure Type: Number
Unit of Measure: Participants
10 6 5 5
42.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 21 after first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 47 49 45 50
Measure Type: Number
Unit of Measure: Participants
20 21 19 22
43.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 21 after first H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 48 46 51
Measure Type: Number
Unit of Measure: Participants
47 40 45 48
44.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to first vaccination and 21 days after last vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 29 30 30 25
Measure Type: Number
Unit of Measure: Participants
TIV H1 antigen 23 14 19 18
TIV H3 antigen 25 18 25 23
TIV B antigen 10 7 4 4
45.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to first vaccination and Day 21 after last vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 38 47 45 47
Measure Type: Number
Unit of Measure: Participants
TIV H1 antigen 27 20 16 24
TIV H3 antigen 30 30 23 29
TIV B antigen 26 19 21 21
46.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to first vaccination and Day 21 after last vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 46 47 50
Measure Type: Number
Unit of Measure: Participants
TIV H1 antigen 35 28 24 33
TIV H3 antigen 34 33 28 30
TIV B antigen 36 22 25 32
47.Secondary Outcome
Title Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination
Hide Description 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.
Time Frame Day 21 after last vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 29 30 30 25
Measure Type: Number
Unit of Measure: Participants
TIV H1 antigen 29 30 29 24
TIV H3 antigen 29 30 29 25
TIV B antigen 10 9 8 5
48.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 21 after last vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 38 47 45 47
Measure Type: Number
Unit of Measure: Participants
TIV H1 antigen 38 43 44 47
TIV H3 antigen 38 43 44 47
TIV B antigen 32 31 33 34
49.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 21 after last vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 46 47 50
Measure Type: Number
Unit of Measure: Participants
TIV H1 antigen 49 46 46 50
TIV H3 antigen 49 46 46 50
TIV B antigen 47 35 40 47
50.Secondary Outcome
Title Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Hide Description 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.
Time Frame Day 21 after the second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 30 31 31 26
Measure Type: Number
Unit of Measure: Participants
23 24 26 19
51.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 21 after the second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 44 47 45 47
Measure Type: Number
Unit of Measure: Participants
38 37 36 37
52.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 21 after the second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 46 47 50
Measure Type: Number
Unit of Measure: Participants
49 42 47 50
53.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 30 30 31 26
Measure Type: Number
Unit of Measure: Participants
23 23 26 19
54.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 44 47 45 47
Measure Type: Number
Unit of Measure: Participants
38 37 36 35
55.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description:
Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
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 Number of Participants Analyzed 49 46 47 50
Measure Type: Number
Unit of Measure: Participants
48 41 43 50
Time Frame Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
Adverse Event Reporting Description For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
 
Arm/Group Title Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Hide Arm/Group Description Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42 Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21 Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
All-Cause Mortality
Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/133 (0.00%)      3/133 (2.26%)      1/133 (0.75%)      2/132 (1.52%)    
Immune system disorders         
Anaphylactic reaction * 1  0/133 (0.00%)  0 0/133 (0.00%)  0 1/133 (0.75%)  1 1/132 (0.76%)  1
Infections and infestations         
Abscess * 1  0/133 (0.00%)  0 1/133 (0.75%)  1 0/133 (0.00%)  0 0/132 (0.00%)  0
Injury, poisoning and procedural complications         
Head injury * 1  0/133 (0.00%)  0 1/133 (0.75%)  1 0/133 (0.00%)  0 0/132 (0.00%)  0
Multiple fractures * 1  0/133 (0.00%)  0 1/133 (0.75%)  1 0/133 (0.00%)  0 0/132 (0.00%)  0
Metabolism and nutrition disorders         
Type 1 diabetes mellitus * 1  0/133 (0.00%)  0 0/133 (0.00%)  0 0/133 (0.00%)  0 1/132 (0.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Group 3: Day 0-H1N1; Day 21-H1N1+TIV Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   124/133 (93.23%)      125/133 (93.98%)      124/133 (93.23%)      125/132 (94.70%)    
Gastrointestinal disorders         
Diarrhoea * 1  18/133 (13.53%)  22 6/133 (4.51%)  7 9/133 (6.77%)  13 10/132 (7.58%)  13
Nausea  1 [1]  25/98 (25.51%)  31 18/100 (18.00%)  34 19/98 (19.39%)  29 13/104 (12.50%)  16
Vomiting  1  16/133 (12.03%)  20 8/133 (6.02%)  12 14/133 (10.53%)  25 11/132 (8.33%)  11
General disorders         
Injection site haematoma * 1  3/133 (2.26%)  3 8/133 (6.02%)  9 6/133 (4.51%)  6 4/132 (3.03%)  4
Pyrexia * 1  5/133 (3.76%)  5 4/133 (3.01%)  4 3/133 (2.26%)  3 8/132 (6.06%)  8
Pyrexia  1  14/133 (10.53%)  15 5/133 (3.76%)  8 15/133 (11.28%)  23 13/132 (9.85%)  13
Irritability  1 [2]  22/35 (62.86%)  38 20/33 (60.61%)  45 23/35 (65.71%)  42 17/28 (60.71%)  28
Feeling hot  1 [1]  25/98 (25.51%)  26 21/100 (21.00%)  38 20/98 (20.41%)  31 15/104 (14.42%)  15
Malaise  1 [3]  24/49 (48.98%)  31 15/49 (30.61%)  35 13/49 (26.53%)  18 14/53 (26.42%)  17
Decreased activity  1 [1]  27/98 (27.55%)  35 21/100 (21.00%)  44 26/98 (26.53%)  40 21/104 (20.19%)  26
Injection site pain  1  70/133 (52.63%)  117 67/133 (50.38%)  112 75/133 (56.39%)  133 65/132 (49.24%)  98
Tenderness  1 [4]  83/133 (62.41%)  155 82/133 (61.65%)  158 91/133 (68.42%)  185 90/132 (68.18%)  159
Injection site erythema  1  75/133 (56.39%)  130 68/133 (51.13%)  131 76/133 (57.14%)  154 72/132 (54.55%)  141
Injection site swelling (functional grading)  1 [5]  35/133 (26.32%)  55 39/133 (29.32%)  70 39/133 (29.32%)  68 51/132 (38.64%)  72
Injection site swelling (measured)  1 [5]  37/133 (27.82%)  60 45/133 (33.83%)  79 43/133 (32.33%)  77 53/132 (40.15%)  77
Infections and infestations         
Nasopharyngitis * 1  13/133 (9.77%)  14 13/133 (9.77%)  14 10/133 (7.52%)  11 11/132 (8.33%)  12
Upper respiratory tract infection * 1  16/133 (12.03%)  16 11/133 (8.27%)  11 15/133 (11.28%)  18 14/132 (10.61%)  20
Metabolism and nutrition disorders         
Decreased Appetite  1 [2]  9/35 (25.71%)  16 8/33 (24.24%)  15 11/35 (31.43%)  15 13/28 (46.43%)  14
Musculoskeletal and connective tissue disorders         
Myalgia  1 [1]  21/98 (21.43%)  30 15/100 (15.00%)  29 23/98 (23.47%)  32 19/104 (18.27%)  23
Nervous system disorders         
Lethargy  1 [2]  14/35 (40.00%)  20 7/33 (21.21%)  14 10/35 (28.57%)  16 9/28 (32.14%)  10
Headache  1 [1]  40/98 (40.82%)  55 27/100 (27.00%)  60 33/98 (33.67%)  53 27/104 (25.96%)  37
Respiratory, thoracic and mediastinal disorders         
Cough * 1  16/133 (12.03%)  16 9/133 (6.77%)  10 9/133 (6.77%)  10 21/132 (15.91%)  23
Nasal congestion * 1  7/133 (5.26%)  8 11/133 (8.27%)  11 8/133 (6.02%)  8 11/132 (8.33%)  11
Oropharyngeal pain * 1  12/133 (9.02%)  13 5/133 (3.76%)  5 4/133 (3.01%)  4 9/132 (6.82%)  10
Rhinorrhoea * 1  23/133 (17.29%)  25 11/133 (8.27%)  12 7/133 (5.26%)  7 12/132 (9.09%)  18
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
[1]
Solicited from participants aged 36 months to 17 years only.
[2]
Solicited from participants aged 6 to less than 36 months only.
[3]
Solicited from participants aged 10 to 17 years only.
[4]
Tenderness was solicited as a reaction at the vaccination site.
[5]
Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Due to difficulties identifying children in the youngest age stratum who were previously primed, enrollment in this stratum was closed prior to meeting the planned number of participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sharon E. Frey, M.D.
Organization: Division of Infectious Diseases and Immunology, Saint Louis University Medical School
Phone: 314-977-5500
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00943202     History of Changes
Other Study ID Numbers: 09-0047
N01AI80003C
First Submitted: July 21, 2009
First Posted: July 22, 2009
Results First Submitted: April 28, 2011
Results First Posted: May 26, 2011
Last Update Posted: April 22, 2013