Trial Outcomes & Findings for Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age (NCT NCT01974895)
NCT ID: NCT01974895
Last Updated: 2018-09-07
Results Overview
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 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), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
COMPLETED
PHASE2
316 participants
28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
2018-09-07
Participant Flow
Not all subjects who withdrew from the study were willing to provide a reason for withdrawal. Thus, the reasons for withdrawal for these subjects are unknown.
2 subjects were allocated subject numbers but study vaccine was not administered, thus were excluded from the study prior to group assignment.
Participant milestones
| Measure |
FluLaval Quadrivalent Group
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
Fluzone Group
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
156
|
|
Overall Study
COMPLETED
|
143
|
141
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
| Measure |
FluLaval Quadrivalent Group
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
Fluzone Group
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Other (Missed Visit)
|
1
|
0
|
|
Overall Study
Other (Reason unknown)
|
9
|
8
|
Baseline Characteristics
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
Baseline characteristics by cohort
| Measure |
FluLaval Quadrivalent Group
n=158 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
Fluzone Group
n=156 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
Total
n=314 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.6 Months
STANDARD_DEVIATION 8.8 • n=5 Participants
|
19.8 Months
STANDARD_DEVIATION 8.9 • n=7 Participants
|
19.7 Months
STANDARD_DEVIATION 8.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 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), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=137 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=143 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.
H1N1 [Day 28 = primed and Day 56 = unprimed]
|
NA Subjects
This primary outcome concerns solely subjects in the FluLaval Quadrivalent Group.
|
115 Subjects
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.
H3N2 [Day 28 = primed and Day 56 = unprimed]
|
NA Subjects
This primary outcome concerns solely subjects in the FluLaval Quadrivalent Group.
|
103 Subjects
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.
Yamagata [Day 28 = primed and Day 56 = unprimed]
|
NA Subjects
This primary outcome concerns solely subjects in the FluLaval Quadrivalent Group.
|
123 Subjects
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.
Victoria [Day 28 = primed and Day 56 = unprimed]
|
NA Subjects
This primary outcome concerns solely subjects in the FluLaval Quadrivalent Group.
|
95 Subjects
|
SECONDARY outcome
Timeframe: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)Population: Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 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), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the Fluzone Group. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=137 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=143 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
H1N1, [Day 28 = primed and Day 56 = unprimed]
|
98 Subjects
|
NA Subjects
This outcome concerns solely subjects in the Fluzone Group.
|
|
Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
H3N2, [Day 28 = primed and Day 56 = unprimed]
|
94 Subjects
|
NA Subjects
This outcome concerns solely subjects in the Fluzone Group.
|
|
Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
Yamagata, [Day 28 = primed and Day 56 = unprimed]
|
115 Subjects
|
NA Subjects
This outcome concerns solely subjects in the Fluzone Group.
|
|
Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
Victoria, [Day 28 = primed and Day 56 = unprimed]
|
17 Subjects
|
NA Subjects
This outcome concerns solely subjects in the Fluzone Group.
|
SECONDARY outcome
Timeframe: On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively)Population: Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=137 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=143 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
H1N1, [Day 0]
|
10.0 Titers
Interval 8.3 to 11.9
|
10.3 Titers
Interval 8.6 to 12.3
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
H1N1, [Day 28 = primed and Day 56 = unprimed]
|
90.8 Titers
Interval 73.2 to 112.6
|
141.3 Titers
Interval 115.1 to 173.5
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
H3N2, [Day 0]
|
11.5 Titers
Interval 9.3 to 14.2
|
11.1 Titers
Interval 9.1 to 13.5
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
H3N2, [Day 28 = primed and Day 56 = unprimed]
|
86.2 Titers
Interval 70.6 to 105.4
|
100.6 Titers
Interval 82.6 to 122.6
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
Yamagata, [Day 0]
|
12.3 Titers
Interval 10.3 to 14.7
|
14.5 Titers
Interval 12.1 to 17.5
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
Yamagata, [Day 28 = primed and Day 56 = unprimed]
|
140.0 Titers
Interval 113.9 to 172.0
|
212.0 Titers
Interval 174.6 to 257.3
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
Victoria, [Day 0]
|
6.6 Titers
Interval 5.9 to 7.5
|
7.7 Titers
Interval 6.6 to 9.1
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
Victoria, [Day 28 = primed and Day 56 = unprimed]
|
12.8 Titers
Interval 10.6 to 15.4
|
69.0 Titers
Interval 54.9 to 86.6
|
SECONDARY outcome
Timeframe: At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)Population: Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=137 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=143 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
H1N1, [Day 0]
|
22 Subjects
|
25 Subjects
|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
H1N1, [Day 28 = primed and Day 56 = unprimed]
|
111 Subjects
|
125 Subjects
|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
H3N2, [Day 0]
|
25 Subjects
|
29 Subjects
|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
H3N2, [Day 28 = primed and Day 56 = unprimed]
|
110 Subjects
|
118 Subjects
|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
Yamagata, [Day 0]
|
22 Subjects
|
31 Subjects
|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
Yamagata, [Day 28 = primed and Day 56 = unprimed]
|
124 Subjects
|
135 Subjects
|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
Victoria, [Day 0]
|
9 Subjects
|
13 Subjects
|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
Victoria, [Day 28 = primed and Day 56 = unprimed]
|
27 Subjects
|
101 Subjects
|
SECONDARY outcome
Timeframe: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)Population: Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=137 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=143 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.
H1N1, [Day 28 = primed and Day 56 = unprimed]
|
9.11 Fold increase
Interval 7.32 to 11.33
|
13.73 Fold increase
Interval 11.1 to 16.99
|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.
H3N2, [Day 28 = primed and Day 56 = unprimed]
|
7.53 Fold increase
Interval 6.36 to 8.9
|
9.09 Fold increase
Interval 7.69 to 10.76
|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.
Yamagata, [Day 28 = primed and Day 56 = unprimed]
|
11.36 Fold increase
Interval 9.09 to 14.19
|
14.59 Fold increase
Interval 11.72 to 18.16
|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.
Victoria, [Day 28 = primed and Day 56 = unprimed]
|
1.93 Fold increase
Interval 1.69 to 2.19
|
8.94 Fold increase
Interval 7.34 to 10.89
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that made the subject cry when limb was moved/spontaneously painful. Grade 3 swelling was greater than 100 millimeters (mm) i.e. \>100mm. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=148 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=151 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 Swelling
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Pain
|
48 Subjects
|
48 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain
|
1 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Redness
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 Redness
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Swelling
|
1 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.
Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. 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.Grade 3 fever was defined as axillary temperature above 39.0°C. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=148 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=151 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Drowsiness
|
56 Subjects
|
60 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Drowsiness
|
3 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Drowsiness
|
48 Subjects
|
52 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Irritability/fussiness
|
67 Subjects
|
76 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Irritability/fussiness
|
6 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Irritability/fussiness
|
60 Subjects
|
66 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Loss of appetite
|
46 Subjects
|
49 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Loss of appetite
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Loss of appetite
|
39 Subjects
|
46 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Fever
|
10 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fever
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Fever
|
8 Subjects
|
9 Subjects
|
SECONDARY outcome
Timeframe: During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.
Any fever was defined as any fever ≥38.0 degrees Celsius (°C) 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 fever was defined as fever ≥39.0 °C. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=148 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=151 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Fever
Any Fever
|
8 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Fever
Grade 3 Fever
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Fever
Related Fever
|
7 Subjects
|
7 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.
Duration was defined as number of days with any grade of local and general symptoms. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=62 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=64 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Duration of Solicited Local and General Symptoms
Pain [Dose 1; N=43,44]
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 5.0
|
|
Duration of Solicited Local and General Symptoms
Pain [Dose 2; N=21,11]
|
1.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 5.0
|
|
Duration of Solicited Local and General Symptoms
Redness [Dose 1; N=2,0]
|
0.0 Days
Interval 0.0 to 0.0
|
1.5 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited Local and General Symptoms
Redness [Dose 2; N=0,0]
|
NA Days
No participants with event
|
NA Days
No participants with event
|
|
Duration of Solicited Local and General Symptoms
Swelling [Dose 1; N=0,1]
|
1.0 Days
Interval 1.0 to 1.0
|
NA Days
No participants with event
|
|
Duration of Solicited Local and General Symptoms
Swelling [Dose 2; N=0,0]
|
NA Days
No participants with event
|
NA Days
No participants with event
|
|
Duration of Solicited Local and General Symptoms
Fever [Dose 1; N=7,8]
|
1.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General Symptoms
Fever [Dose 2; N=3,4]
|
1.5 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 2.0 to 3.0
|
|
Duration of Solicited Local and General Symptoms
Drowsiness [Dose 1; N=56;48]
|
2.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Drowsiness [Dose 2; N=22,20]
|
1.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General Symptoms
Irritability/fussiness [Dose 1; N=64,62]
|
2.0 Days
Interval 1.0 to 6.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Irritability/fussiness [Dose 2; N=34,27]
|
2.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local and General Symptoms
Loss of appetite [Dose 1; N=41,40]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Loss of appetite [Dose 2; N=17,13]
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Day 180)Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety 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). Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=156 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=158 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
Any MAE(s)
|
89 Subjects
|
77 Subjects
|
|
Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
Related MAE(s)
|
4 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Day 180)Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.
pIMDs were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject. Related pIMD was defined as a pIMD assessed by the investigator to be causally related to the study vaccination. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=156 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=158 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)
Any pIMD(s)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)
Related pIMD(s)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety 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 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010
Outcome measures
| Measure |
Fluzone Group
n=156 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=158 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Any Unsolicited AEs
|
75 Subjects
|
77 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Grade 3 Unsolicited AEs
|
12 Subjects
|
12 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Related Unsolicited AEs
|
7 Subjects
|
11 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 - Day 180)Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
Outcome measures
| Measure |
Fluzone Group
n=156 Participants
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
FluLaval Quadrivalent Group
n=158 Participants
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAEs
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAEs
|
0 Subjects
|
0 Subjects
|
Adverse Events
FluLaval Quadrivalent Group
Fluzone Group
Serious adverse events
| Measure |
FluLaval Quadrivalent Group
n=158 participants at risk
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
Fluzone Group
n=156 participants at risk
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
|---|---|---|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.3%
2/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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%
0/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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 neck
|
0.00%
0/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
0.64%
1/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
Convulsion
|
0.00%
0/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
0.64%
1/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
0.63%
1/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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%
0/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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%
0/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
0.64%
1/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
0.00%
0/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
0.64%
1/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
Sleep apnoea syndrome
|
0.63%
1/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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%
0/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
Viral infection
|
0.63%
1/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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%
0/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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=158 participants at risk
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
|
Fluzone Group
n=156 participants at risk
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
|
|---|---|---|
|
General disorders
Pain
|
31.8%
48/151 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
32.4%
48/148 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
39.7%
60/151 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
37.8%
56/148 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
50.3%
76/151 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
45.3%
67/148 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
32.5%
49/151 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
31.1%
46/148 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
4.6%
7/151 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
5.4%
8/148 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
8.9%
14/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
8.3%
13/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
8.2%
13/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
7.7%
12/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
7.0%
11/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
7.7%
12/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
Upper respiratory tract infection
|
7.0%
11/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
7.1%
11/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
5.1%
8/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
5.8%
9/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
Vomiting
|
5.7%
9/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
4.5%
7/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
|
9.5%
15/158 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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.
|
2.6%
4/156 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
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