Trial Outcomes & Findings for Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years (NCT NCT00372255)
NCT ID: NCT00372255
Last Updated: 2019-05-06
Results Overview
A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
240 participants
Primary outcome timeframe
28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Results posted on
2019-05-06
Participant Flow
This study was conducted by a principal investigator and 22 investigators in 18 centers in Germany.
Participant milestones
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
114
|
|
Overall Study
COMPLETED
|
108
|
113
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Overall Study
Withdrawn for other reasons
|
2
|
1
|
Baseline Characteristics
Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
Baseline characteristics by cohort
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=110 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
n=114 Participants
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.4 Years
STANDARD_DEVIATION 1.13 • n=5 Participants
|
11.3 Years
STANDARD_DEVIATION 1.07 • n=7 Participants
|
9.4 Years
STANDARD_DEVIATION 2.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
107 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Specified
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.
Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=97 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New Caledonia (H1N1), Dose 1
|
290.4 Titer
Interval 165.6 to 509.3
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New Caledonia (H1N1), Dose 2
|
719.2 Titer
Interval 503.3 to 1027.7
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New York (H3N2), Dose 1
|
381.2 Titer
Interval 281.3 to 516.6
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New York (H3N2), Dose 2
|
393.9 Titer
Interval 313.5 to 494.9
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
B/Jiangsu, Dose 1
|
97.7 Titer
Interval 68.6 to 139.2
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
B/Jiangsu, Dose 2
|
301.8 Titer
Interval 246.3 to 369.9
|
—
|
PRIMARY outcome
Timeframe: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=97 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New Caledonia (H1N1), Dose 1
|
16.7 Fold increase
Interval 11.8 to 23.8
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New Caledonia (H1N1), Dose 2
|
40.7 Fold increase
Interval 32.6 to 50.8
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New York (H3N2), Dose 1
|
14.9 Fold increase
Interval 10.9 to 20.3
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New York (H3N2), Dose 2
|
15.4 Fold increase
Interval 11.9 to 20.0
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
B/Jiangsu, Dose 1
|
8.5 Fold increase
Interval 6.7 to 10.7
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
B/Jiangsu, Dose 2
|
26.1 Fold increase
Interval 21.4 to 31.9
|
—
|
PRIMARY outcome
Timeframe: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.
A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=97 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New Caledonia (H1N1), Dose 1
|
63 Participants
|
—
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New Caledonia (H1N1), Dose 2
|
93 Participants
|
—
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New York (H3N2), Dose 1
|
79 Participants
|
—
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A/New York (H3N2), Dose 2
|
80 Participants
|
—
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
B/Jiangsu, Dose 1
|
66 Participants
|
—
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
B/Jiangsu, Dose 2
|
92 Participants
|
—
|
SECONDARY outcome
Timeframe: 21 days post-vaccination (Day 21)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.
Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=106 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A/New Caledonia (H1N1), Dose 1
|
1326.6 Titres
Interval 856.7 to 2054.3
|
—
|
|
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A/New York (H3N2), Dose 1
|
300.6 Titres
Interval 241.5 to 374.2
|
—
|
|
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
B/Jiangsu, Dose 1
|
218.9 Titres
Interval 169.1 to 283.5
|
—
|
SECONDARY outcome
Timeframe: 21 days post-vaccination (Day 21)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=106 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A/New Caledonia (H1N1), Dose 1
|
50.2 Fold increase
Interval 36.2 to 69.8
|
—
|
|
SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A/New York (H3N2), Dose 1
|
10.3 Fold increase
Interval 8.2 to 12.8
|
—
|
|
SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
B/Jiangsu, Dose 1
|
12.6 Fold increase
Interval 10.4 to 15.3
|
—
|
SECONDARY outcome
Timeframe: 21 days post-vaccination (Day 21)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.
A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=106 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A/New Caledonia (H1N1), Dose 1
|
90 Participants
|
—
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A/New York (H3N2), Dose 1
|
83 Participants
|
—
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
B/Jiangsu, Dose 1
|
90 Participants
|
—
|
SECONDARY outcome
Timeframe: 21 days post-vaccination (Day 21)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.
Seroprotection power (SPP) was defined as the proportion of the subjects unprotected before vaccination (titre \< 40) who were protected after vaccination (titer ≥ 40). The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=75 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years
A/New Caledonia (H1N1), Dose 1
|
33 Participants
|
—
|
|
Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years
A/New York (H3N2), Dose 1
|
52 Participants
|
—
|
|
Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years
B/Jiangsu, Dose 1
|
62 Participants
|
—
|
SECONDARY outcome
Timeframe: 21 days post-vaccination (Day 21)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=106 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A/New Caledonia (H1N1), Dose 1
|
91 Participants
|
—
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A/New York (H3N2), Dose 1
|
101 Participants
|
—
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
B/Jiangsu, Dose 1
|
93 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available. Post Dose 2 results are not available for the 10-13 years Group as these subjects received only one dose.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=110 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
n=114 Participants
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Pain, Any, Dose 1
|
62 Participants
|
54 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Pain, Grade 3, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Redness, Any, Dose 1
|
28 Participants
|
24 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Redness, > 50 mm, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Swelling, Any, Dose 1
|
28 Participants
|
39 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Swelling, > 50 mm, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Pain, Any, Dose 2
|
68 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Pain, Grade 3, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Redness, Any, Dose 2
|
31 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Redness, > 50 mm, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Swelling, Any, Dose 2
|
35 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Swelling, > 50 mm, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Pain, Any, Across doses
|
82 Participants
|
54 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Pain, Grade 3, Across doses
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Redness, Any, Across doses
|
39 Participants
|
24 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Redness, > 50 mm, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Swelling, Any, Across doses
|
44 Participants
|
39 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Swelling, > 50 mm, Across doses
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available. Post Dose 2 results are not available for the 10-13 years Group as these subjects received only one dose.
Assessed solicited general symptoms were Arthralgia, Fatigue, Fever, Headache, Myalgia, Shivering and Sweating. Any= occurrence of the symptom regardless of intensity grade. Grade 3 fever = Grade 3 symptoms greater than (\>) 39.0 °C. Related = symptoms considered by the investigator to have a causal relationship to study vaccination.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=110 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
n=114 Participants
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Arthralgia, Any, Dose 1
|
10 Participants
|
6 Participants
|
|
Number of Subjects With Solicited General Symptoms
Arthralgia, Grade 3, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Arthralgia, Related, Dose 1
|
9 Participants
|
6 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fatigue, Any, Dose 1
|
22 Participants
|
22 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fatigue, Grade 3, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fatigue, Related, Dose 1
|
18 Participants
|
10 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fever (Axillary), ≥ 37.5ºC, Dose 1
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fever (Axillary), > 39.0ºC, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fever (Axillary), Related, Dose 1
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Headache, Any, Dose 1
|
26 Participants
|
19 Participants
|
|
Number of Subjects With Solicited General Symptoms
Headache, Grade 3, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Headache, Related, Dose 1
|
19 Participants
|
10 Participants
|
|
Number of Subjects With Solicited General Symptoms
Myalgia, Any, Dose 1
|
22 Participants
|
13 Participants
|
|
Number of Subjects With Solicited General Symptoms
Myalgia, Grade 3, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Myalgia, Related, Dose 1
|
19 Participants
|
10 Participants
|
|
Number of Subjects With Solicited General Symptoms
Shivering, Any, Dose 1
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Solicited General Symptoms
Shivering, Grade 3, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Shivering, Related, Dose 1
|
10 Participants
|
6 Participants
|
|
Number of Subjects With Solicited General Symptoms
Sweating, Any, Dose 1
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms
Sweating, Grade 3, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Sweating, Related, Dose 1
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Arthralgia, Any, Dose 2
|
3 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Arthralgia, Grade 3, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Arthralgia, Related, Dose 2
|
2 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Fatigue, Any, Dose 2
|
12 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Fatigue, Grade 3, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Fatigue, Related, Dose 2
|
6 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Fever (Axillary), ≥ 37.5ºC, Dose 2
|
5 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Fever (Axillary), > 39.0ºC, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Fever (Axillary), Related, Dose 2
|
4 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Headache, Any, Dose 2
|
22 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Headache, Grade 3, Dose 2
|
2 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Headache, Related, Dose 2
|
16 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Myalgia, Any, Dose 2
|
19 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Myalgia, Grade 3, Dose 2
|
2 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Myalgia, Related, Dose 2
|
14 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Shivering, Any, Dose 2
|
8 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Shivering, Grade 3, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Shivering, Related, Dose 2
|
5 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Sweating, Any, Dose 2
|
3 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Sweating, Grade 3, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Sweating, Related, Dose 2
|
2 Participants
|
—
|
|
Number of Subjects With Solicited General Symptoms
Arthralgia, Any, Across doses
|
13 Participants
|
6 Participants
|
|
Number of Subjects With Solicited General Symptoms
Arthralgia, Grade 3, Across doses
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Arthralgia, Related, Across doses
|
11 Participants
|
6 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fatigue, Any, Across doses
|
30 Participants
|
22 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fatigue, Grade 3, Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fatigue, Related, Across doses
|
22 Participants
|
10 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fever (Axillary), ≥ 37.5ºC, Across doses
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fever (Axillary), > 39.0ºC, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Fever (Axillary), Related, Across doses
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Headache, Any, Across doses
|
38 Participants
|
19 Participants
|
|
Number of Subjects With Solicited General Symptoms
Headache, Grade 3, Across doses
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Headache, Related, Across doses
|
29 Participants
|
10 Participants
|
|
Number of Subjects With Solicited General Symptoms
Myalgia, Any, Across doses
|
28 Participants
|
13 Participants
|
|
Number of Subjects With Solicited General Symptoms
Myalgia, Grade 3, Across doses
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Myalgia, Related, Across doses
|
23 Participants
|
10 Participants
|
|
Number of Subjects With Solicited General Symptoms
Shivering, Any, Across doses
|
17 Participants
|
8 Participants
|
|
Number of Subjects With Solicited General Symptoms
Shivering, Grade 3, Across doses
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Shivering, Related, Across doses
|
14 Participants
|
6 Participants
|
|
Number of Subjects With Solicited General Symptoms
Sweating, Any, Across doses
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms
Sweating, Grade 3, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Sweating, Related, Across doses
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During 31 days after the study vaccine dose (Day 0-30)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=110 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
n=114 Participants
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events.
Subjects with any AE(s)
|
52 Participants
|
30 Participants
|
|
Number of Subjects With Unsolicited Adverse Events.
Subjects with Grade 3 AE(s)
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Unsolicited Adverse Events.
Subjects with related AE(s)
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years GroupPopulation: The analysis was performed on the Total Vaccinated Cohort, included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available.
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=110 Participants
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
n=114 Participants
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
Any SAEs
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Related SAEs
|
0 Participants
|
0 Participants
|
Adverse Events
Influsplit SSW 2005/2006 6-9 Years Group
Serious events: 3 serious events
Other events: 100 other events
Deaths: 0 deaths
Influsplit SSW 2005/2006 10-13 Years Group
Serious events: 0 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=110 participants at risk
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
n=114 participants at risk
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Congenital, familial and genetic disorders
Hereditary fructose intolerance
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Gastrointestinal disorders
Enteritis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Tonsillitis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Renal and urinary disorders
Haematuria
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
Other adverse events
| Measure |
Influsplit SSW 2005/2006 6-9 Years Group
n=110 participants at risk
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
|
Influsplit SSW 2005/2006 10-13 Years Group
n=114 participants at risk
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
4/110 • Number of events 4 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
2.6%
3/114 • Number of events 3 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
13/110 • Number of events 13 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
5.3%
6/114 • Number of events 7 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
General disorders
Axillary pain
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Bronchitis
|
1.8%
2/110 • Number of events 2 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
General disorders
Chills
|
15.5%
17/110 • Number of events 18 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
7.0%
8/114 • Number of events 8 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Eye disorders
Conjunctivitis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
5/110 • Number of events 6 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
4.4%
5/114 • Number of events 6 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
4/110 • Number of events 6 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
3/110 • Number of events 3 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Ear infection
|
1.8%
2/110 • Number of events 2 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Gastrointestinal disorders
Enteritis
|
3.6%
4/110 • Number of events 5 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
35.5%
39/110 • Number of events 59 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
21.1%
24/114 • Number of events 24 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
General disorders
Fatigue
|
27.3%
30/110 • Number of events 34 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
19.3%
22/114 • Number of events 22 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Gastrointestinal disorders
Flatulence
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Gastroenteritis
|
0.91%
1/110 • Number of events 2 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
1.8%
2/114 • Number of events 2 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Nervous system disorders
Headache
|
34.5%
38/110 • Number of events 50 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
16.7%
19/114 • Number of events 20 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.5%
5/110 • Number of events 5 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
3.5%
4/114 • Number of events 4 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Immune system disorders
Hypersensitivity
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
General disorders
Injection site pruritus
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Lice infestation
|
1.8%
2/110 • Number of events 2 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.5%
28/110 • Number of events 41 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
11.4%
13/114 • Number of events 13 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
2/110 • Number of events 2 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
3/110 • Number of events 3 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Otitis media
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Ear and labyrinth disorders
Otosalpingitis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
General disorders
Pain
|
74.5%
82/110 • Number of events 130 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
47.4%
54/114 • Number of events 54 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Pharyngitis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.7%
3/110 • Number of events 3 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
1.8%
2/114 • Number of events 2 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Renal and urinary disorders
Proteinuria
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
General disorders
Pyrexia
|
10.0%
11/110 • Number of events 12 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
3.5%
4/114 • Number of events 4 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
1.8%
2/114 • Number of events 2 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Rhinitis
|
6.4%
7/110 • Number of events 8 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Streptococcal infection
|
2.7%
3/110 • Number of events 3 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
General disorders
Swelling
|
40.0%
44/110 • Number of events 63 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
34.2%
39/114 • Number of events 39 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Tonsillitis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
1.8%
2/110 • Number of events 2 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Tracheitis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.8%
13/110 • Number of events 14 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
4.4%
5/114 • Number of events 5 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/110 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.88%
1/114 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Viral infection
|
2.7%
3/110 • Number of events 3 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
5/110 • Number of events 5 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
1.8%
2/114 • Number of events 2 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
|
Infections and infestations
Vulvitis
|
0.91%
1/110 • Number of events 1 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
0.00%
0/114 • Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
|
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