Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age (NCT NCT02242643)
NCT ID: NCT02242643
Last Updated: 2018-09-07
Results Overview
Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2432 participants
Primary outcome timeframe
28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
Results posted on
2018-09-07
Participant Flow
Primed subjects:Received atleast 2 doses of seasonal influenza vaccine since 1 July 2010 or atleast 1 dose of the 2013-2014 seasonal influenza vaccine. Unprimed subjects:Did not receive any seasonal influenza vaccine or received only 1 dose of seasonal influenza vaccine since 1 July 2010, but did not receive any 2013-2014 seasonal influenza vaccine
Data has been analyzed in sub-groups by age: 6-17 months and 18-35 months and by priming status. 6 subjects were allocated subject numbers but did not receive the study vaccine dose and for 2 subjects the blood samples were withdrawn but they did not participate in the study due to screening failure.
Participant milestones
| Measure |
FluLaval™ Quadrivalent Group
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Overall Study
STARTED
|
1207
|
1217
|
|
Overall Study
COMPLETED
|
1132
|
1139
|
|
Overall Study
NOT COMPLETED
|
75
|
78
|
Reasons for withdrawal
| Measure |
FluLaval™ Quadrivalent Group
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
15
|
10
|
|
Overall Study
Migrated/moved from study area
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
54
|
61
|
|
Overall Study
Child placed in foster care by family
|
0
|
1
|
|
Overall Study
Non-compliance
|
1
|
0
|
|
Overall Study
Consent withdrawal by parent
|
1
|
0
|
|
Overall Study
Protocol requirements not followed
|
1
|
0
|
|
Overall Study
Language barrier
|
1
|
0
|
|
Overall Study
Withdrawal by subject at Visit 2
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age
Baseline characteristics by cohort
| Measure |
FluLaval™ Quadrivalent Group
n=1207 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1217 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Total
n=2424 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.4 Months
STANDARD_DEVIATION 8.7 • n=5 Participants
|
19.5 Months
STANDARD_DEVIATION 8.9 • n=7 Participants
|
19.45 Months
STANDARD_DEVIATION 8.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
547 Participants
n=5 Participants
|
582 Participants
n=7 Participants
|
1129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
660 Participants
n=5 Participants
|
635 Participants
n=7 Participants
|
1295 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=974 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=980 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains
H3N2 [N=972,980]
|
740 Subjects
|
680 Subjects
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains
Victoria [N=973,980]
|
631 Subjects
|
475 Subjects
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains
H1N1 [N=972,980]
|
716 Subjects
|
660 Subjects
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains
Yamagata [N=974,980]
|
833 Subjects
|
723 Subjects
|
PRIMARY outcome
Timeframe: At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=1013 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1028 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.
H1N1
|
98.8 Titers
Interval 90.3 to 108.2
|
84.4 Titers
Interval 76.9 to 92.6
|
|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.
H3N2
|
97.7 Titers
Interval 90.3 to 105.7
|
84.3 Titers
Interval 77.6 to 91.6
|
|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.
Yamagata
|
257.5 Titers
Interval 240.9 to 275.3
|
164.2 Titers
Interval 151.8 to 177.6
|
|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.
Victoria
|
55.1 Titers
Interval 50.8 to 59.8
|
33.4 Titers
Interval 30.6 to 36.4
|
SECONDARY outcome
Timeframe: At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=1013 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1028 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Day 0
|
11.0 Titers
Interval 10.2 to 12.0
|
11.1 Titers
Interval 10.2 to 12.0
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Day 28/Day 56
|
98.8 Titers
Interval 90.3 to 108.2
|
84.4 Titers
Interval 76.9 to 92.6
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Day 0
|
9.2 Titers
Interval 8.6 to 9.8
|
9.6 Titers
Interval 8.9 to 10.3
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Day 28/Day 56
|
97.7 Titers
Interval 90.3 to 105.7
|
84.3 Titers
Interval 77.6 to 91.6
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Day 0
|
20.3 Titers
Interval 18.8 to 22.0
|
20.6 Titers
Interval 19.0 to 22.4
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Day 28/Day 56
|
257.5 Titers
Interval 240.9 to 275.3
|
164.2 Titers
Interval 151.8 to 177.6
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Day 0
|
6.2 Titers
Interval 6.0 to 6.5
|
6.3 Titers
Interval 6.0 to 6.6
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Day 28/Day 56
|
55.1 Titers
Interval 50.8 to 59.8
|
33.4 Titers
Interval 30.6 to 36.4
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 6-17M, Day 0
|
7.2 Titers
Interval 6.5 to 7.9
|
7.1 Titers
Interval 6.5 to 7.7
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 6-17M, Day 28/Day 56
|
42.7 Titers
Interval 37.1 to 49.0
|
43.2 Titers
Interval 37.3 to 50.0
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 18-35M, Day 0
|
14.5 Titers
Interval 13.0 to 16.2
|
14.6 Titers
Interval 13.1 to 16.4
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 18-35M, Day 28/Day 56
|
170.9 Titers
Interval 155.2 to 188.3
|
129.6 Titers
Interval 116.3 to 144.3
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 6-17M, Day 0
|
5.8 Titers
Interval 5.5 to 6.1
|
6.2 Titers
Interval 5.8 to 6.7
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 6-17M, Day 28/Day 56
|
58.9 Titers
Interval 52.2 to 66.4
|
54.8 Titers
Interval 47.9 to 62.7
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 18-35M, Day 0
|
12.3 Titers
Interval 11.1 to 13.6
|
12.5 Titers
Interval 11.2 to 13.9
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 18-35M, Day 28/Day 56
|
136.0 Titers
Interval 123.7 to 149.6
|
111.1 Titers
Interval 100.6 to 122.7
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 6-17M, Day 0
|
12.2 Titers
Interval 11.1 to 13.5
|
13.0 Titers
Interval 11.8 to 14.4
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 6-17M, Day 28/Day 56
|
151.0 Titers
Interval 137.4 to 165.9
|
79.1 Titers
Interval 70.9 to 88.1
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 18-35M, Day 0
|
28.0 Titers
Interval 25.2 to 31.0
|
27.4 Titers
Interval 24.5 to 30.7
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 18-35M, Day 28/Day 56
|
364.8 Titers
Interval 336.7 to 395.3
|
262.1 Titers
Interval 239.3 to 287.1
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 6-17M, Day 0
|
5.5 Titers
Interval 5.3 to 5.7
|
5.6 Titers
Interval 5.3 to 5.9
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 6-17M, Day 28/Day 56
|
68.7 Titers
Interval 61.8 to 76.3
|
31.9 Titers
Interval 28.4 to 35.7
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 18-35M, Day 0
|
6.8 Titers
Interval 6.4 to 7.3
|
6.8 Titers
Interval 6.3 to 7.3
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 18-35M, Day 28/Day 56
|
47.8 Titers
Interval 42.6 to 53.6
|
34.4 Titers
Interval 30.4 to 38.8
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Unprimed, Day 0
|
7.5 Titers
Interval 6.8 to 8.4
|
8.2 Titers
Interval 7.4 to 9.2
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Unprimed, Day 56
|
51.4 Titers
Interval 44.7 to 59.1
|
56.0 Titers
Interval 48.4 to 64.8
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Primed, Day 0
|
14.4 Titers
Interval 12.9 to 16.1
|
13.8 Titers
Interval 12.3 to 15.4
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Primed, Day 28
|
158.8 Titers
Interval 143.3 to 176.0
|
115.0 Titers
Interval 102.6 to 128.9
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Unprimed, Day 0
|
6.4 Titers
Interval 5.9 to 7.0
|
6.9 Titers
Interval 6.3 to 7.6
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Unprimed, Day 56
|
75.0 Titers
Interval 66.0 to 85.3
|
76.8 Titers
Interval 66.9 to 88.3
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Primed, Day 0
|
11.8 Titers
Interval 10.7 to 13.0
|
12.2 Titers
Interval 10.9 to 13.5
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Primed, Day 28
|
118.4 Titers
Interval 107.5 to 130.3
|
90.4 Titers
Interval 81.8 to 100.0
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Unprimed, Day 0
|
11.4 Titers
Interval 10.3 to 12.6
|
12.4 Titers
Interval 11.2 to 13.7
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Unprimed, Day 56
|
179.8 Titers
Interval 163.7 to 197.4
|
98.1 Titers
Interval 88.1 to 109.3
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Primed, Day 0
|
30.5 Titers
Interval 27.6 to 33.8
|
30.1 Titers
Interval 27.0 to 33.6
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Primed, Day 28
|
334.3 Titers
Interval 306.4 to 364.7
|
242.2 Titers
Interval 219.1 to 267.7
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Unprimed, Day 0
|
5.6 Titers
Interval 5.3 to 5.9
|
5.6 Titers
Interval 5.3 to 6.0
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Unprimed, Day 56
|
91.7 Titers
Interval 83.8 to 100.3
|
44.8 Titers
Interval 40.1 to 50.0
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Primed, Day 0
|
6.7 Titers
Interval 6.3 to 7.2
|
6.8 Titers
Interval 6.4 to 7.3
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Primed, Day 28
|
38.1 Titers
Interval 34.0 to 42.8
|
26.7 Titers
Interval 23.6 to 30.3
|
SECONDARY outcome
Timeframe: At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)Population: The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=1013 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1028 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Day 0
|
191 Subjects
|
190 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Day 28/56
|
814 Subjects
|
775 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Day 0
|
135 Subjects
|
140 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Day 28/56
|
833 Subjects
|
800 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Day 0
|
324 Subjects
|
336 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Day 28/56
|
983 Subjects
|
911 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Day 0
|
40 Subjects
|
46 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Day 28/56
|
669 Subjects
|
512 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 6-17M, Day 0
|
32 Subjects
|
25 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 6-17M, Day 28/Day 56
|
245 Subjects
|
240 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 18-35M, Day 0
|
159 Subjects
|
165 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 18-35M, Day 28/Day 56
|
569 Subjects
|
535 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 6-17M, Day 0
|
12 Subjects
|
15 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 6-17M, Day 28/Day 56
|
281 Subjects
|
272 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 18-35M, Day 0
|
123 Subjects
|
125 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 18-35M, Day 28/Day 56
|
552 Subjects
|
528 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 6-17M, Day 0
|
64 Subjects
|
70 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 6-17M, Day 28/Day 56
|
377 Subjects
|
311 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 18-35M, Day 0
|
260 Subjects
|
266 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 18-35M, Day 28/Day 56
|
606 Subjects
|
600 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 6-17M, Day 0
|
2 Subjects
|
7 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 6-17M, Day 28/Day 56
|
313 Subjects
|
206 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 18-35M, Day 0
|
38 Subjects
|
39 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 18-35M, Day 28/Day 56
|
356 Subjects
|
306 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Unprimed, Day 0
|
42 Subjects
|
46 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Unprimed, Day 56
|
282 Subjects
|
294 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Primed, Day 0
|
149 Subjects
|
144 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Primed, Day 28
|
532 Subjects
|
481 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Unprimed, Day 0
|
27 Subjects
|
31 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Unprimed, Day 56
|
321 Subjects
|
330 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Primed, Day 0
|
108 Subjects
|
109 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Primed, Day 28
|
512 Subjects
|
470 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Unprimed, Day 0
|
65 Subjects
|
80 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Unprimed, Day 56
|
407 Subjects
|
362 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Primed, Day 0
|
259 Subjects
|
256 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Primed, Day 28
|
576 Subjects
|
549 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Unprimed, Day 0
|
9 Subjects
|
11 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Unprimed, Day 56
|
379 Subjects
|
277 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Primed, Day 0
|
31 Subjects
|
35 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Primed, Day 28
|
290 Subjects
|
235 Subjects
|
SECONDARY outcome
Timeframe: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=974 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=980 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1 [N=972,980]
|
716 Subjects
|
660 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2 [N=972,980]
|
740 Subjects
|
680 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata [N=974,980]
|
833 Subjects
|
723 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria [N=973,980]
|
631 Subjects
|
475 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 6-17M [N=376,375]
|
220 Subjects
|
216 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 18-35M [N=596,605]
|
496 Subjects
|
444 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 6-17M [N=376,375]
|
260 Subjects
|
250 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 18-35M [N=596,605]
|
480 Subjects
|
430 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 6-17M [N=376,375]
|
299 Subjects
|
232 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 18-35M [N=598,605]
|
534 Subjects
|
491 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 6-17M [N=376,375]
|
291 Subjects
|
189 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 18-35M [N=597,605]
|
340 Subjects
|
286 Subjects
|
SECONDARY outcome
Timeframe: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)Population: The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=974 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=980 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1 [N=972,980]
|
9.0 Fold increase
Interval 8.4 to 9.7
|
7.7 Fold increase
Interval 7.1 to 8.3
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2 [N=972,980]
|
10.7 Fold increase
Interval 10.0 to 11.6
|
8.9 Fold increase
Interval 8.2 to 9.7
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata [N=974,980]
|
12.7 Fold increase
Interval 11.7 to 13.7
|
8.1 Fold increase
Interval 7.5 to 8.8
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria [N=973,980]
|
8.7 Fold increase
Interval 8.1 to 9.4
|
5.4 Fold increase
Interval 5.0 to 5.8
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 6-17M [N=376,375]
|
6.0 Fold increase
Interval 5.3 to 6.8
|
6.1 Fold increase
Interval 5.2 to 7.1
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, 18-35M [N=596,605]
|
11.7 Fold increase
Interval 10.7 to 12.8
|
8.9 Fold increase
Interval 8.1 to 9.8
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 6-17M [N=376,375]
|
10.2 Fold increase
Interval 9.0 to 11.6
|
8.8 Fold increase
Interval 7.7 to 10.2
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, 18-35M [N=596,605]
|
11.1 Fold increase
Interval 10.1 to 12.1
|
9.0 Fold increase
Interval 8.2 to 9.9
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 6-17M [N=376,375]
|
12.3 Fold increase
Interval 10.7 to 14.3
|
6.1 Fold increase
Interval 5.3 to 7.0
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, 18-35M [N=598,605]
|
12.9 Fold increase
Interval 11.8 to 14.0
|
9.7 Fold increase
Interval 8.9 to 10.6
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 6-17M [N=376,375]
|
12.3 Fold increase
Interval 11.0 to 13.8
|
5.7 Fold increase
Interval 5.1 to 6.4
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, 18-35M [N=597,605]
|
7.0 Fold increase
Interval 6.4 to 7.7
|
5.2 Fold increase
Interval 4.7 to 5.7
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Unprimed [N=402,417]
|
6.9 Fold increase
Interval 6.1 to 7.8
|
6.8 Fold increase
Interval 5.9 to 7.8
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H1N1, Primed [N=570, 563]
|
10.9 Fold increase
Interval 10.0 to 12.0
|
8.5 Fold increase
Interval 7.7 to 9.3
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Unprimed [N=402,417]
|
11.8 Fold increase
Interval 10.4 to 13.4
|
11.2 Fold increase
Interval 9.7 to 12.9
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
H3N2, Primed [N=570, 563]
|
10.0 Fold increase
Interval 9.1 to 10.9
|
7.6 Fold increase
Interval 6.9 to 8.3
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Unprimed [N=402,417]
|
16.0 Fold increase
Interval 13.9 to 18.5
|
8.0 Fold increase
Interval 6.9 to 9.3
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Yamagata, Primed [N=572, 563]
|
10.7 Fold increase
Interval 9.9 to 11.6
|
8.2 Fold increase
Interval 7.6 to 8.9
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Unprimed [N=402,417]
|
16.2 Fold increase
Interval 14.8 to 17.8
|
8.0 Fold increase
Interval 7.2 to 8.8
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Victoria, Primed [N=571, 563]
|
5.6 Fold increase
Interval 5.1 to 6.1
|
4.0 Fold increase
Interval 3.6 to 4.4
|
SECONDARY outcome
Timeframe: During a 7-day (Day 0 - Day 6) follow-up period after each vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=1156 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1151 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, 6-17M, Dose 2 [N=373,372]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, Across doses [N=1156,1151]
|
509 Subjects
|
462 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, Across doses [N=1156,1151]
|
34 Subjects
|
19 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, Across doses [N=1156,1151]
|
16 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, Across doses [N=1156,1151]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, Across doses [N=1156,1151]
|
11 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, Across doses [N=1156,1151]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, 6-17M, Dose 1 [N=478,465]
|
175 Subjects
|
173 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, 6-17M, Dose 1 [N=478,465]
|
11 Subjects
|
12 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, 6-17M, Dose 1 [N=478,465]
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, Primed, Across Doses [N=633,630]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, 6-17M, Dose 1 [N=478,465]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, 6-17M, Dose 1 [N=478,465]
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, 6-17M, Dose 1 [N=478,465]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, 18-35M, Dose 1 [N=673,681]
|
289 Subjects
|
256 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, 18-35M, Dose 1 [N=673,681]
|
17 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, 18-35M, Dose 1 [N=673,681]
|
13 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, 18-35M, Dose 1 [N=673,681]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, 18-35M, Dose 1 [N=673,681]
|
7 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, 18-35M, Dose 1 [N=673,681]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Sweling, Primed, Across Doses [N=633,630]
|
7 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, 6-17M, Dose 2 [N=373,372]
|
103 Subjects
|
108 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, Primed, Across Doses [N=633,630]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, 6-17M, Dose 2 [N=373,372]
|
6 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, 6-17M, Dose 2 [N=373,372]
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, 6-17M, Dose 2 [N=373,372]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, 6-17M, Dose 2 [N=373,372]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, 18-35M, Dose 2 [N=117,121]
|
35 Subjects
|
39 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, 18-35M, Dose 2 [N=117,121]
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, 18-35M, Dose 2 [N=117,121]
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, 18-35M, Dose 2 [N=117,121]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, 18-35M, Dose 2 [N=117,121]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, 18-35M, Dose 2 [N=117,121]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, 6-17M, Across Doses [N=481,469]
|
211 Subjects
|
196 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, 6-17M, Across Doses [N=481,469]
|
15 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, 6-17M, Across Doses [N=481,469]
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, 6-17M, Across Doses [N=481,469]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, 6-17M, Across Doses [N=481,469]
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, 6-17M, Across Doses [N=481,469]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, 18-35M, Across Doses [N=675,682]
|
298 Subjects
|
266 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, 18-35M, Across Doses [N=675,682]
|
19 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, 18-35M, Across Doses [N=675,682]
|
13 Subjects
|
14 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, 18-35M, Across Doses [N=675,682]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, 18-35M, Across Doses [N=675,682]
|
7 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, 18-35M, Across Doses [N=675,682]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, Unprimed, Dose 1 [N=518,516]
|
187 Subjects
|
190 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, Unprimed, Dose 1 [N=518,516]
|
12 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, Unprimed, Dose 1 [N=518,516]
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, Unprimed, Dose 1 [N=518,516]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, Unprimed, Dose 1 [N=518,516
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, Unprimed, Dose 1 [N=518,516]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, Primed, Dose 1 [N=633,630]
|
277 Subjects
|
239 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, Primed, Dose 1 [N=633,630]
|
16 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, Primed, Dose 1 [N=633,630]
|
13 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, Primed, Dose 1 [N=633,630]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, Primed, Dose 1 [N=633,630]
|
7 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, Primed, Dose 1 [N=633,630]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, Unprimed, Dose 2 [N=490,493]
|
138 Subjects
|
147 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, Unprimed, Dose 2 [N=490,493]
|
9 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, Unprimed, Dose 2 [N=490,493]
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, Unprimed, Dose 2 [N=490,493]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, Unprimed, Dose 2 [N=490,493]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, Unprimed, Dose 2 [N=490,493]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, Unprimed, Across Doses [N=523,521]
|
232 Subjects
|
223 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, Unprimed, Across Doses [N=523,521]
|
18 Subjects
|
14 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, Unprimed, Across Doses [N=523,521]
|
3 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, Unprimed, Across Doses[N=523,521]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, Unprimed, Across Doses [N=523,521]
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling,Unprimed, Across Doses[N=523,521]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, Primed, Across Doses [N=633,630]
|
277 Subjects
|
239 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, Primed, Across Doses [N=633,630]
|
16 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, Primed, Across Doses [N=633,630]
|
13 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, Dose 1 [N=1151,1146]
|
464 Subjects
|
429 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, Dose 1 [N=1151,1146]
|
28 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, Dose 1 [N=1151,1146]
|
15 Subjects
|
15 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, Dose 1 [N=1151,1146]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, Dose 1 [N=1151,1146]
|
11 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, Dose 1 [N=1151,1146]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Pain, Dose 2 [N=490,493]
|
138 Subjects
|
147 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Pain, Dose 2 [N=490,493]
|
9 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Redness, Dose 2 [N=490,493]
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Redness, Dose 2 [N=490,493]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Swelling, Dose 2 [N=490,493]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Swelling, Dose 2 [N=490,493]
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after each vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C.
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=1159 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1152 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, Dose 1 [N=1155,1148]
|
424 Subjects
|
424 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, Dose 1 [N=1155,1148]
|
31 Subjects
|
30 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, Dose 1 [N=1155,1148]
|
365 Subjects
|
381 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, Dose 1 [N=1155,1148]
|
146 Subjects
|
147 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), Dose 1 [N=1155,1148]
|
65 Subjects
|
67 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, Dose 1 [N=1155,1148]
|
16 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, Dose 1 [N=1155,1148]
|
41 Subjects
|
50 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C Related Fever, Dose 1 [N=1155,1148]
|
41 Subjects
|
50 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, Dose 1 [N=1155,1148]
|
570 Subjects
|
527 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability, Dose 1 [N=1155,1148]
|
44 Subjects
|
34 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability, Dose 1 [N=1155,1148]
|
499 Subjects
|
473 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite, Dose 1 [N=1155,1148]
|
334 Subjects
|
328 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Loss of Appetite, Dose 1 [N=1155,1148]
|
19 Subjects
|
15 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Loss of Appetite, Dose 1 [N=1155,1148]
|
280 Subjects
|
290 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, Dose 2 [N=490,495]
|
157 Subjects
|
166 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, Dose 2 [N=490,495]
|
10 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, Dose 2 [N=490,495]
|
133 Subjects
|
136 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, Dose 2 [N=490,495]
|
60 Subjects
|
48 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), Dose 2 [N=490,495]
|
31 Subjects
|
22 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, Dose 2 [N=490,495]
|
9 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, Dose 2 [N=490,495]
|
22 Subjects
|
14 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C Related Fever, Dose 2 [N=490,495]
|
20 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, Dose 2 [N=490,495]
|
211 Subjects
|
214 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability, Dose 2 [N=490,495]
|
21 Subjects
|
14 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability, Dose 2 [N=490,495]
|
185 Subjects
|
175 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite, Dose 2 [N=490,495]
|
110 Subjects
|
116 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Loss of Appetite, Dose 2 [N=490,495]
|
8 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Loss of Appetite, Dose 2 [N=490,495]
|
91 Subjects
|
87 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, Across Doses [N=1159,1152]
|
471 Subjects
|
471 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, Across Doses [N=1159,1152]
|
36 Subjects
|
34 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, Across Doses [N=1159,1152]
|
411 Subjects
|
425 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, Across Doses [N=1159,1152]
|
183 Subjects
|
178 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), Across Doses [N=1159,1152
|
91 Subjects
|
86 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, Across Doses [N=1159,1152]
|
25 Subjects
|
17 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, Across Doses [N=1159,1152]
|
62 Subjects
|
63 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C Related Fever, Across Doses [N=1159,1152]
|
60 Subjects
|
62 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, Across Doses [N=1159,1152]
|
630 Subjects
|
582 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability, Across Doses [N=1159,1152]
|
61 Subjects
|
45 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability, Across Doses [N=1159,1152]
|
558 Subjects
|
525 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite, Across Doses [N=1159,1152]
|
391 Subjects
|
385 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Loss of Appetite,Across Doses[N=1159,1152
|
26 Subjects
|
19 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Loss of Appetite,Across Doses[N=1159,1152]
|
328 Subjects
|
337 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, 6-17M, Dose 1 [N=478,467]
|
200 Subjects
|
210 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, 6-17M, Dose 1 [N=478,467]
|
16 Subjects
|
17 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, 6-17M, Dose 1 [N=478,467]
|
171 Subjects
|
189 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, 6-17M, Dose 1 [N=478,467]
|
80 Subjects
|
70 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), 6-17M, Dose 1 [N=478,467]
|
40 Subjects
|
31 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, 6-17M, Dose 1 [N=478,467]
|
12 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, 6-17M, Dose 1 [N=478,467]
|
25 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C Related Fever, 6-17M, Dose 1 [N=478,467]
|
25 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, 6-17M, Dose 1 [N=478,467]
|
273 Subjects
|
252 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability, 6-17M, Dose 1 [N=478,467]
|
24 Subjects
|
15 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability, 6-17M, Dose 1 [N=478,467]
|
239 Subjects
|
227 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite, 6-17M, Dose 1 [N=478,467]
|
141 Subjects
|
131 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Loss of Appetite, 6-17M,Dose 1 [N=478,467]
|
7 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Loss of Appetite, 6-17M, Dose 1[N=478,467]
|
122 Subjects
|
115 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, 18-35M, Dose 1 [N=677,681]
|
224 Subjects
|
214 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, 18-35M, Dose 1 [N=677,681]
|
15 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, 18-35M, Dose 1 [N=677,681]
|
194 Subjects
|
192 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, 18-35M, Dose 1 [N=677,681]
|
66 Subjects
|
77 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), 18-35M, Dose 1 [N=677,681]
|
25 Subjects
|
36 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, 18-35M, Dose 1 [N=677,681]
|
4 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, 18-35M, Dose 1 [N=677,681]
|
16 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C Related Fever, 18-35M, Dose 1 [N=677,681]
|
16 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, 18-35M, Dose 1 [N=677,681]
|
297 Subjects
|
275 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability, 18-35M, Dose 1 [N=677,681]
|
20 Subjects
|
19 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability, 18-35M, Dose 1 [N=677,681]
|
260 Subjects
|
246 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite, 18-35M, Dose 1 [N=677,681]
|
193 Subjects
|
197 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Loss of Appetite,18-35M,Dose 1 [N=677,681]
|
12 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Loss of Appetite,18-35M,Dose 1 [N=677,681]
|
158 Subjects
|
175 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, 6-17M, Dose 2 [N=373,374]
|
129 Subjects
|
142 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, 6-17M, Dose 2 [N=373,374]
|
10 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, 6-17M, Dose 2 [N=373,374]
|
111 Subjects
|
115 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, 6-17M, Dose 2 [N=373,374]
|
47 Subjects
|
38 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), 6-17M, Dose 2 [N=373,374]
|
23 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, 6-17M, Dose 2 [N=373,374]
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, 6-17M, Dose 2 [N=373,374]
|
17 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C Related Fever, 6-17M, Dose 2 [N=373,374]
|
15 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, 6-17M, Dose 2 [N=373,374]
|
168 Subjects
|
177 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability, 6-17M, Dose 2 [N=373,374]
|
16 Subjects
|
12 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability, 6-17M, Dose 2 [N=373,374]
|
150 Subjects
|
141 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite, 6-17M, Dose 2 [N=373,374]
|
90 Subjects
|
91 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Loss of Appetite, 6-17M, Dose 2[N=373,374]
|
8 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Loss of Appetite, 6-17M Dose 2[N=373,374]
|
73 Subjects
|
66 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, 18-35M, Dose 2 [N=117,121]
|
28 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, 18-35M, Dose 2 [N=117,121]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, 18-35M, Dose 2 [N=117,121]
|
22 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, 18-35M, Dose 2 [N=117,121]
|
13 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), 18-35M, Dose 2 [N=117,121]
|
8 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, 18-35M, Dose 2 [N=117,121]
|
4 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, 18-35M, Dose 2 [N=117,121]
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C Related Fever, 18-35M, Dose 2 [N=117,121]
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, 18-35M, Dose 2 [N=117,121]
|
43 Subjects
|
37 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability, 18-35M, Dose 2 [N=117,121]
|
5 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability, 18-35M, Dose 2 [N=117,121]
|
35 Subjects
|
34 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite, 18-35M, Dose 2 [N=117,121]
|
20 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Loss of Appetite, 18-35M,Dose 2[N=117,121]
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Loss of Appetite, 18-35M,Dose 2[N=117,121]
|
18 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, 6-17M, Across Doses [N=481,470]
|
238 Subjects
|
248 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, 6-17M, Across Doses[N=481,470]
|
21 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, 6-17M, Across Doses[N=481,470]
|
209 Subjects
|
224 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, 6-17M, Across Doses [N=481,470]
|
109 Subjects
|
93 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), 6-17M, Across Doses [N=481,470]
|
60 Subjects
|
45 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, 6-17M, Across Doses [N=481,470]
|
17 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, 6-17M, Across Doses [N=481,470]
|
41 Subjects
|
36 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°CRelated Fever,6-17M,Across Doses[N=481,470]
|
39 Subjects
|
35 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, 6-17M, Across Doses [N=481,470]
|
315 Subjects
|
297 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability,6-17M,Across Doses[N=481,470]
|
36 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability,6-17M,Across Doses[N=481,470]
|
280 Subjects
|
269 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite,6-17M,Across Doses[N=481,470]
|
188 Subjects
|
175 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade3 LossofAppetite,6-17M,AcrossDoses[N=481,470]
|
14 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related LossofAppetite,6-17M,AcrossDoses[N=481,470
|
159 Subjects
|
148 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, 18-35M, Across Doses [N=678,682]
|
233 Subjects
|
223 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness,18-35M, Across Doses[N=678,682]
|
15 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness,18-35M,Across Doses [N=678,682]
|
202 Subjects
|
201 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, 18-35M, Across Doses [N=678,682]
|
74 Subjects
|
85 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), 18-35M, Across Doses [N=678,682]
|
31 Subjects
|
41 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, 18-35M, Across Doses [N=678,682]
|
8 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, 18-35M, Across Doses [N=678,682]
|
21 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°CRelated Fever,18-35M,Across Doses[N=678,682
|
21 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, 18-35M, Across Doses [N=678,682]
|
315 Subjects
|
285 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade3 Irritability,18-35M,Across Doses[N=678,682]
|
25 Subjects
|
20 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability,18-35M,Across Doses[N=678,682
|
278 Subjects
|
256 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss ofAppetite,18-35M,Across Doses[N=678,682]
|
203 Subjects
|
210 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade3LossofAppetite,18-35M,AcrossDoses[N=678,682]
|
12 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
RelatedLossofAppetite,18-35M,AcrossDoses[N=678,682
|
169 Subjects
|
189 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, Unprimed, Dose 1 [N=520,518]
|
212 Subjects
|
211 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, Unprimed, Dose 1 [N=520,518]
|
15 Subjects
|
19 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, Unprimed, Dose 1 [N=520,518]
|
182 Subjects
|
189 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, Unprimed, Dose 1 [N=520,518]
|
80 Subjects
|
69 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), Unprimed, Dose 1 [N=520,518]
|
41 Subjects
|
33 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, Unprimed, Dose 1 [N=520,518]
|
12 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, Unprimed, Dose 1 [N=520,518]
|
24 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C Related Fever, Unprimed, Dose 1[N=520,518]
|
24 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, Unprimed, Dose 1 [N=520,518]
|
274 Subjects
|
256 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability, Unprimed, Dose 1 [N=520,518]
|
21 Subjects
|
14 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability, Unprimed, Dose 1 [N=520,518]
|
240 Subjects
|
227 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite, Unprimed, Dose 1 [N=520,518]
|
154 Subjects
|
138 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade3 Loss of Appetite,Unprimed,Dose 1[N=520,518]
|
7 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Loss of Appetite,Unprimed,Dose1[N=520,518]
|
129 Subjects
|
119 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, Primed, Dose 1 [N=635,630]
|
212 Subjects
|
213 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, Primed, Dose 1 [N=635,630]
|
16 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, Primed, Dose 1 [N=635,630]
|
183 Subjects
|
192 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, Primed, Dose 1 [N=635,630]
|
66 Subjects
|
78 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C) Primed, Dose 1 [N=635,630]
|
24 Subjects
|
34 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, Primed, Dose 1 [N=635,630]
|
4 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fevers, Primed, Dose 1 [N=635,630]
|
17 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C Related Fever, Primed, Dose 1 [N=635,630]
|
17 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, Primed, Dose 1 [N=635,630]
|
296 Subjects
|
271 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability, Primed, Dose 1 [N=635,630]
|
23 Subjects
|
20 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability, Primed, Dose 1 [N=635,630]
|
259 Subjects
|
246 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite, Primed, Dose 1 [N=635,630]
|
180 Subjects
|
190 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Loss of Appetite, Primed,Dose 1[N=635,630]
|
12 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Loss of Appetite,Primed,Dose 1 [N=635,630]
|
151 Subjects
|
171 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, Unprimed, Dose 2 [N=490,495]
|
157 Subjects
|
166 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, Unprimed, Dose 2 [N=490,495]
|
10 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness, Unprimed, Dose 2 [N=490,495]
|
133 Subjects
|
136 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, Unprimed, Dose 2 [N=490,495]
|
60 Subjects
|
48 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), Unprimed, Dose 2 [N=490,495]
|
31 Subjects
|
22 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, Unprimed, Dose 2 [N=490,495]
|
9 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, Unprimed, Dose 2 [N=490,495]
|
22 Subjects
|
14 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C Related Fever, Unprimed,Dose 2 [N=490,495]
|
20 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, Unprimed, Dose 2 [N=490,495]
|
211 Subjects
|
214 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Irritability, Unprimed, Dose 2 [N=490,495]
|
21 Subjects
|
14 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability, Unprimed,Dose 2 [N=490,495]
|
185 Subjects
|
175 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite, Unprimed, Dose 2 [N=490,495]
|
110 Subjects
|
116 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade3 Loss of Appetite,Unprimed,Dose 2[N=490,495]
|
8 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Loss of Appetite,Unprimed,Dose 2[N=490,495
|
91 Subjects
|
87 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, Unprimed, Across Doses [N=524,522]
|
259 Subjects
|
258 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade3 Drowsiness,Unprimed,Across Doses[N=524,522]
|
20 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
RelatedDrowsiness,Unprimed,Across Doses[N=524,522]
|
228 Subjects
|
233 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, Unprimed, Across Doses [N=524,522]
|
117 Subjects
|
100 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), Unprimed,Across Doses [N=524,522]
|
67 Subjects
|
52 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, Unprimed, Across Doses [N=524,522]
|
21 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, Unprimed, Across Doses [N=524,522]
|
45 Subjects
|
38 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°CRelatedFever,Unprimed,AcrossDoses[N=524,522
|
43 Subjects
|
37 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability,Unprimed, Across Doses[N=524,522]
|
334 Subjects
|
311 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade3Irritability,Unprimed,AcrossDoses[N=524,522]
|
38 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
RelatedIrritability,Unprimed,AcrossDoses[N=524,522
|
299 Subjects
|
279 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
AnyLoss ofAppetite,Unprimed,AcrossDoses[N=524,522]
|
211 Subjects
|
195 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade3LossofAppetite,Unprimed,AcrossDosesN=524,522
|
14 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
RelatedLossofAppetite,UnprimedAcrossDosesN=524,522
|
177 Subjects
|
166 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Drowsiness, Primed, Across Doses [N=635,630]
|
212 Subjects
|
213 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Drowsiness, Primed,Across Doses[N=635,630]
|
16 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Drowsiness,Primed,Across Doses[N=635,630]
|
183 Subjects
|
192 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Fever, Primed, Across Doses [N=635,630]
|
66 Subjects
|
78 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever (≥38.0°C), Primed, Across Doses [N=635,630]
|
24 Subjects
|
34 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Fever, Primed, Across Doses [N=635,630]
|
4 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Fever, Primed, Across Doses [N=635,630]
|
17 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
≥38.0°C RelatedFever,Primed,Across Doses[N=635,630
|
17 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Irritability, Primed, Across Doses [N=635,630]
|
296 Subjects
|
271 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade3 Irritability,Primed,Across Doses[N=635,630]
|
23 Subjects
|
20 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Irritability,Primed,AcrossDoses[N=635,630]
|
259 Subjects
|
246 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Loss of Appetite,Primed,AcrossDoses[N=635,630]
|
180 Subjects
|
190 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade3 LossofAppetite,Primed,AcrossDoses[N=635,630
|
12 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
RelatedLossofAppetite,Primed,AcrossDoses[N=635,630
|
151 Subjects
|
171 Subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after each vaccination.Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
Duration was defined as number of days with any grade of local and general symptoms.
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=570 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=527 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Drowsiness, Dose 1 [N=424,424]
|
1.0 Days
Interval 1.0 to 7.0
|
1.5 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Drowsiness, Dose 2 [N=157,166]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Irritability, Dose 1 [N=570, 527]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Irritability, Dose 2 [N=211,214]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Loss of Appetite, Dose 1 [N=334, 328]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Loss of Appetite, Dose 2 [N=110,116]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Pain, Dose 1 [N=464,429]
|
1.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Pain, Dose 2 [N=138,147]
|
1.0 Days
Interval 1.0 to 6.0
|
1.0 Days
Interval 1.0 to 5.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Redness, Dose 1 [N=15,15]
|
2.0 Days
Interval 1.0 to 4.0
|
1.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Redness, Dose 2 [N=1,2]
|
1.0 Days
Interval 1.0 to 1.0
|
1.5 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Swelling, Dose 1 [N=11,5]
|
2.0 Days
Interval 1.0 to 5.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever, Dose 1 [N=146,147]
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever, Dose 2 [N=60,48]
|
1.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Drowsiness, 6-17M, Dose 1 [N=200,210]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Drowsiness, 18-35M, Dose 1 [N=224,214]
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Drowsiness, 6-17M, Dose 2 [N=129,142]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Drowsiness, 18-35M, Dose 2 [N=28,24]
|
2.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 4.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Irritability, 6-17M, Dose 1 [N=273,252]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Irritability, 18-35M, Dose 1 [N=297,275]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Irritability, 6-17M, Dose 2 [N=168,177]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Irritability, 18-35M, Dose 2 [N=43,37]
|
2.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Loss of Appetite, 6-17M, Dose 1 [N=141,131]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Loss of Appetite, 18-35M, Dose 1 [N=193,197]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Loss of Appetite, 6-17M, Dose 2 [N=90,91]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Loss of Appetite, 18-35M, Dose 2 [N=20,25]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Pain, 6-17M, Dose 1 [N=175,173]
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Pain, 18-35M, Dose 1 [N=289,256]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Pain, 6-17M, Dose 2 [N=103,108]
|
1.0 Days
Interval 1.0 to 6.0
|
2.0 Days
Interval 1.0 to 5.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Pain, 18-35M, Dose 2 [N=35,39]
|
1.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 4.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Redness, 6-17M, Dose 1 [N=2,2]
|
1.5 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 1.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Redness, 18-35M, Dose 1 [N=13,13]
|
2.0 Days
Interval 1.0 to 4.0
|
1.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Redness, 6-17M, Dose 2 [N=1,0]
|
1.0 Days
Interval 1.0 to 1.0
|
0.0 Days
Interval 0.0 to 0.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Redness, 18-35M, Dose 2 [N=0,2]
|
0.0 Days
Interval 0.0 to 0.0
|
1.5 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Swelling, 6-17M, Dose 1 [N=4,0]
|
1.5 Days
Interval 1.0 to 2.0
|
0.0 Days
Interval 0.0 to 0.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Swelling, 18-35M, Dose 1 [N=7,5]
|
2.0 Days
Interval 1.0 to 5.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever, 6-17M, Dose 1 [N=80,70]
|
2.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever, 18-35M, Dose 1 [N=66,77]
|
1.0 Days
Interval 1.0 to 6.0
|
1.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever, 6-17M, Dose 2 [N=47,38]
|
1.0 Days
Interval 1.0 to 7.0
|
1.5 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever, 18-35M, Dose 2 [N=13,10]
|
1.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Drowsiness, Unprimed, Dose 1 [N=212,211]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Drowsiness, Primed, Dose 1 [N=212,213]
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Drowsiness, Unprimed, Dose 2 [N=157,166]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Irritability, Unprimed, Dose 1 [N=274,256]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Irritability, Primed, Dose 1 [N=296,271]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Irritability, Unprimed, Dose 2 [N=211,214]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Loss of Appetite, Unprimed, Dose 1 [N=154,138]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Loss of Appetite, Primed, Dose 1 [N=180,190]
|
1.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Loss of Appetite, Unprimed, Dose 2 [N=110,116]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Pain, Unprimed, Dose 1 [N=187,190]
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Pain, Primed, Dose 1 [N=277,239]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Pain, Unprimed, Dose 2 [N=138,147]
|
1.0 Days
Interval 1.0 to 6.0
|
1.0 Days
Interval 1.0 to 5.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Redness, Unprimed, Dose 1 [N=2,2]
|
1.5 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Redness, Primed, Dose 1 [N=13,13]
|
2.0 Days
Interval 1.0 to 4.0
|
1.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Redness, Unprimed, Dose 2 [N=1,2]
|
1.0 Days
Interval 1.0 to 1.0
|
1.5 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Swelling, Unprimed, Dose 1 [N=4,0]
|
1.5 Days
Interval 1.0 to 2.0
|
0.0 Days
Interval 0.0 to 0.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Swelling, Primed, Dose 1 [N=7,5]
|
2.0 Days
Interval 1.0 to 5.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever, Unprimed, Dose 1 [N=80,69]
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever, Primed, Dose 1 [N=66,78]
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Fever, Unprimed, Dose 2 [N=60,48]
|
1.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: During a 2-day (Days 0-1) follow-up period after each vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature \< 38.0°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C.
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=1159 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1152 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
Any Fever, Dose 1 [N=1155,1148]
|
63 Subjects
|
74 Subjects
|
|
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
Fever (≥38.0°C), Dose 1 [N=1155,1148]
|
30 Subjects
|
34 Subjects
|
|
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
Grade 3 Fever (>39.0°C), Dose 1 [N=1155,1148]
|
6 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
Any Fever, Dose 2 [N=490,495]
|
21 Subjects
|
22 Subjects
|
|
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
Fever (≥38.0°C), Dose 2 [N=490,495]
|
12 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
Grade 3 Fever (>39.0°C), Dose 2 [N=490,495]
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
Any Fever, Across Doses [N=1159,1152]
|
82 Subjects
|
93 Subjects
|
|
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
Fever (≥38.0°C), Across Doses [N=1159,1152]
|
42 Subjects
|
43 Subjects
|
|
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
Grade 3 Fever (>39.0°C), Across Doses[N=1159,1152]
|
9 Subjects
|
6 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0 -180)Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=1207 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1217 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).
Any MAE(s) [N=1207,1217]
|
727 Subjects
|
719 Subjects
|
|
Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).
Any MAE(s), 6-17M [N=500,502]
|
322 Subjects
|
323 Subjects
|
|
Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).
Any MAE(s), 18-35M [N=707,715]
|
405 Subjects
|
396 Subjects
|
|
Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).
Any MAE(s), Unprimed [N=550,560]
|
344 Subjects
|
337 Subjects
|
|
Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).
Any MAE(s), Primed [N=657,657]
|
383 Subjects
|
382 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0 -180)Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=1207 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1217 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any pIMD(s) [N=1207,1217]
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related pIMD(s) [N=1207,1217]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any pIMD(s), 6-17M [N=500,502]
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related pIMD(s), 6-17M [N=500,502]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any pIMD(s), 18-35M [N=707,715]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related pIMD(s), 18-35M [N=707,715]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any pIMD(s), Unprimed [N=550,560]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related pIMD(s), Unprimed [N=550,560]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any pIMD(s), Primed [N=657,657]
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related pIMD(s), Primed [N=657,657]
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=1207 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1217 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Unsolicited AEs [N=1207,1217]
|
549 Subjects
|
537 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Unsolicited AEs [N=1207,1217]
|
70 Subjects
|
75 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Unsolicited AEs [N=1207,1217]
|
71 Subjects
|
71 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Unsolicited AEs, 6-17M [N=500,502]
|
268 Subjects
|
270 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Unsolicited AEs, 6-17M [N=500,502]
|
32 Subjects
|
48 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Unsolicited AEs, 6-17M [N=500,502]
|
36 Subjects
|
33 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Unsolicited AEs, 18-35M [N=707,715]
|
281 Subjects
|
267 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Unsolicited AEs, 18-35M [N=707,715]
|
38 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Unsolicited AEs, 18-35M [N=707,715]
|
35 Subjects
|
38 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Unsolicited AEs, Unprimed [N=550,560]
|
310 Subjects
|
302 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Unsolicited AEs, Unprimed [N=550,560]
|
35 Subjects
|
48 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Unsolicited AEs, Unprimed [N=550,560]
|
40 Subjects
|
35 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any Unsolicited AEs, Primed [N=657,657]
|
239 Subjects
|
235 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Grade 3 Unsolicited AEs, Primed [N=657,657]
|
35 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related Unsolicited AEs, Primed [N=657,657]
|
31 Subjects
|
36 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0 -180)Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
FluLaval™ Quadrivalent Group
n=1207 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1217 Participants
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any SAE(s), Unprimed [N=550,560]
|
8 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any SAE(s) [N=1207,1217]
|
22 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related SAE(s) [N=1207,1217]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any SAE(s), 6-17M [N=500,502]
|
11 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related SAE(s), 6-17M [N=500,502]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any SAE(s), 18-35M [N=707,715]
|
11 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related SAE(s), 18-35M [N=707,715]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related SAE(s), Unprimed [N=550,560]
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Any SAE(s), Primed [N=657,657]
|
14 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Related SAE(s), Primed [N=657,657]
|
0 Subjects
|
0 Subjects
|
Adverse Events
FluLaval™ Quadrivalent Group
Serious events: 5 serious events
Other events: 932 other events
Deaths: 0 deaths
Fluzone® Quadrivalent Group
Serious events: 4 serious events
Other events: 895 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FluLaval™ Quadrivalent Group
n=1207 participants at risk
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1217 participants at risk
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Nervous system disorders
Febrile convulsion
|
0.41%
5/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.33%
4/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.17%
2/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.25%
3/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
2/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Bronchiolitis
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.16%
2/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Gastroenteritis
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.16%
2/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Cellulitis
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.17%
2/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Urinary tract infection
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Abscess
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B precursor type acute leukaemia
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Croup infectious
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Developmental delay
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Groin abscess
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Vascular disorders
Kawasaki's disease
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Pneumonia
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.08%
1/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Social circumstances
Sexual abuse
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Staphylococcal abscess
|
0.08%
1/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
Other adverse events
| Measure |
FluLaval™ Quadrivalent Group
n=1207 participants at risk
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
Fluzone® Quadrivalent Group
n=1217 participants at risk
Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
9.2%
111/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
8.4%
102/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
70/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
6.3%
77/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.9%
59/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
6.2%
76/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
66/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
4.4%
54/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
66/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
4.4%
53/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Otitis media
|
5.1%
61/1207 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
4.0%
49/1217 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Drowsiness
|
40.6%
471/1159 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
40.9%
471/1152 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Fever
|
7.1%
82/1159 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
8.1%
93/1152 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Irritability/Fussiness
|
54.4%
630/1159 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
50.5%
582/1152 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Loss of Appetite
|
33.7%
391/1159 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
33.4%
385/1152 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Pain
|
44.0%
509/1156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
40.1%
462/1151 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER