Trial Outcomes & Findings for Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years. (NCT NCT00454909)
NCT ID: NCT00454909
Last Updated: 2018-06-08
Results Overview
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
873 participants
Primary outcome timeframe
At Day 0 (PRE)
Results posted on
2018-06-08
Participant Flow
Out of the 873 subjects enrolled in the study, only 872 subjects received the vaccination course and started the study.
Participant milestones
| Measure |
Nimenrix 11-25Y Group
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
587
|
197
|
88
|
|
Overall Study
COMPLETED
|
580
|
194
|
86
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
2
|
Reasons for withdrawal
| Measure |
Nimenrix 11-25Y Group
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Migrated/moved from study area
|
0
|
0
|
1
|
|
Overall Study
Lost to follow-up (complete vaccination)
|
5
|
3
|
1
|
|
Overall Study
Others
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.
Baseline characteristics by cohort
| Measure |
Nimenrix 11-25Y Group
n=587 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=197 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=88 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Total
n=872 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.8 Years
STANDARD_DEVIATION 2.69 • n=5 Participants
|
14.7 Years
STANDARD_DEVIATION 2.78 • n=7 Participants
|
10 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
14.29 Years
STANDARD_DEVIATION 2.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
274 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
426 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
313 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
446 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African heritage/African American
|
35 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
49 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian heritage
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian heritage
|
17 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese heritage
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian-South East Asian heritage
|
40 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African heritage
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European heritage
|
290 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
419 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
138 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Day 0 (PRE)Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Outcome measures
| Measure |
Nimenrix 11-25Y Group
n=506 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=174 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=77 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenA
|
49 Participants
|
13 Participants
|
5 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenC
|
275 Participants
|
113 Participants
|
40 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenW-135
|
114 Participants
|
51 Participants
|
11 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenY
|
269 Participants
|
94 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: At Month 1Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Outcome measures
| Measure |
Nimenrix 11-25Y Group
n=517 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=174 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=79 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenA
|
415 Participants
|
118 Participants
|
70 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenC
|
490 Participants
|
171 Participants
|
78 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenW-135
|
438 Participants
|
114 Participants
|
73 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenY
|
492 Participants
|
139 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and Month 1Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Outcome measures
| Measure |
Nimenrix 11-25Y Group
n=517 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=174 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=79 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenA, PRE
|
68 Participants
|
18 Participants
|
7 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenA, Month 1
|
421 Participants
|
118 Participants
|
71 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenC, PRE
|
276 Participants
|
114 Participants
|
40 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenC, Month 1
|
490 Participants
|
171 Participants
|
78 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenW-135, PRE
|
118 Participants
|
51 Participants
|
11 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenW-135, Month 1
|
441 Participants
|
117 Participants
|
73 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenY, PRE
|
273 Participants
|
94 Participants
|
32 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenY, Month 1
|
492 Participants
|
139 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and Month 1Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days
Antibody titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Nimenrix 11-25Y Group
n=517 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=174 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=79 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenA, PRE
|
2.6 Titers
Interval 2.5 to 2.8
|
2.4 Titers
Interval 2.2 to 2.6
|
2.4 Titers
Interval 2.1 to 2.9
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenA, Month 1
|
57.2 Titers
Interval 48.8 to 67.0
|
36.0 Titers
Interval 26.1 to 49.7
|
91.5 Titers
Interval 64.0 to 130.8
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenC, PRE
|
12.8 Titers
Interval 10.9 to 15.1
|
17.9 Titers
Interval 13.5 to 23.6
|
9.7 Titers
Interval 6.7 to 14.2
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenC, Month 1
|
506.7 Titers
Interval 419.1 to 612.5
|
285.8 Titers
Interval 214.7 to 380.5
|
765.9 Titers
Interval 505.3 to 1160.9
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenW-135, PRE
|
5.7 Titers
Interval 4.8 to 6.8
|
8.6 Titers
Interval 6.1 to 12.1
|
4.2 Titers
Interval 2.8 to 6.4
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenW-135, Month 1
|
124.2 Titers
Interval 106.2 to 145.2
|
74.1 Titers
Interval 51.1 to 107.5
|
153.8 Titers
Interval 109.9 to 215.1
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenY, PRE
|
22.6 Titers
Interval 18.3 to 27.8
|
27.6 Titers
Interval 19.0 to 40.2
|
13.7 Titers
Interval 8.0 to 23.6
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenY, Month 1
|
260.0 Titers
Interval 225.2 to 300.2
|
110.6 Titers
Interval 77.6 to 157.9
|
315.0 Titers
Interval 223.6 to 443.7
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination periodPopulation: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
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 |
Nimenrix 11-25Y Group
n=579 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=194 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=86 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Any, D0-3
|
317 Participants
|
105 Participants
|
48 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Grade 3, D0-3
|
9 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Any, D0-3
|
77 Participants
|
21 Participants
|
15 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Grade 3, D0-3
|
9 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Any, D0-3
|
62 Participants
|
13 Participants
|
18 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Grade 3, D0-3
|
11 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Any, D0-7
|
318 Participants
|
105 Participants
|
48 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Grade 3, D0-7
|
9 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Any, D0-7
|
77 Participants
|
21 Participants
|
15 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Grade 3, D0-7
|
9 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Any, D0-7
|
63 Participants
|
13 Participants
|
18 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Grade 3, D0-7
|
11 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination periodPopulation: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Assessed solicited general symptoms were fatigue, fever \[defined as orally temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Nimenrix 11-25Y Group
n=579 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=194 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=86 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Any, D0-3
|
156 Participants
|
55 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Grade 3, D0-3
|
10 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Related, D0-3
|
139 Participants
|
49 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fever (orally), Any, D0-3
|
34 Participants
|
11 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fever (orally), Grade 3, D0-3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fever (orally), Related, D0-3
|
28 Participants
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Gastrointestinal symptoms, Any, D0-3
|
87 Participants
|
26 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Gastrointestinal symptoms, Grade 3, D0-3
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Gastrointestinal symptoms, Related, D0-3
|
74 Participants
|
22 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Any, D0-3
|
161 Participants
|
60 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Grade 3, D0-3
|
11 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Related, D0-3
|
139 Participants
|
51 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Any, D0-7
|
172 Participants
|
62 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Grade 3, D0-7
|
19 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Related, D0-7
|
147 Participants
|
53 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fever (orally), Any, D0-7
|
41 Participants
|
16 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fever (orally), Grade 3, D0-7
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fever (orally), Related, D0-7
|
29 Participants
|
13 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Gastrointestinal symptoms, Any, D0-7
|
109 Participants
|
32 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Gastrointestinal symptoms, Grade 3, D0-7
|
8 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Gastrointestinal symptoms, Related, D0-7
|
86 Participants
|
24 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Any, D0-7
|
191 Participants
|
72 Participants
|
30 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Grade 3, D0-7
|
16 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Related, D0-7
|
157 Participants
|
57 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) follow-up period after vaccinationPopulation: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were 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 |
Nimenrix 11-25Y Group
n=587 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=197 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=88 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
104 Participants
|
37 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 6Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Serious adverse events (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 |
Nimenrix 11-25Y Group
n=587 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=197 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=88 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
5 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 6Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Outcome measures
| Measure |
Nimenrix 11-25Y Group
n=587 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=197 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=88 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With New Onset Chronic Illness(es) (NOCI)
|
8 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 6Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Outcome measures
| Measure |
Nimenrix 11-25Y Group
n=587 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=197 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=88 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Rash
|
14 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 6Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Outcome measures
| Measure |
Nimenrix 11-25Y Group
n=587 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=197 Participants
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=88 Participants
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
|
24 Participants
|
9 Participants
|
2 Participants
|
Adverse Events
Nimenrix 11-25Y Group
Serious events: 5 serious events
Other events: 438 other events
Deaths: 0 deaths
Menactra Group
Serious events: 2 serious events
Other events: 142 other events
Deaths: 0 deaths
Nimenrix 10Y Group
Serious events: 2 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nimenrix 11-25Y Group
n=587 participants at risk
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=197 participants at risk
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=88 participants at risk
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.34%
2/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
1.1%
1/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.51%
1/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Cellulitis
|
0.17%
1/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.17%
1/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.51%
1/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
Injury, poisoning and procedural complications
Post procedural diarrhoea
|
0.17%
1/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.17%
1/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.17%
1/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.17%
1/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
1.1%
1/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Swelling
|
0.17%
1/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.17%
1/587 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/197 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
0.00%
0/88 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
Other adverse events
| Measure |
Nimenrix 11-25Y Group
n=587 participants at risk
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=197 participants at risk
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix 10Y Group
n=88 participants at risk
Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
General disorders
Pain (Days 0-3)
|
54.7%
317/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
54.1%
105/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
55.8%
48/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Redness (Days 0-3)
|
13.3%
77/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
10.8%
21/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
17.4%
15/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Swelling (Days 0-3)
|
10.7%
62/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
6.7%
13/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
20.9%
18/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Pain (Days 0-7)
|
54.9%
318/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
54.1%
105/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
55.8%
48/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Redness (Days 0-7)
|
13.3%
77/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
10.8%
21/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
17.4%
15/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Swelling (Days 0-7)
|
10.9%
63/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
6.7%
13/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
20.9%
18/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Fatigue (Days 0-3)
|
26.9%
156/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
28.4%
55/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
27.9%
24/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Fever/Orally (Days 0-3)
|
5.9%
34/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
5.7%
11/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
7.0%
6/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Gastrointestinal (Days 0-3)
|
15.0%
87/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
13.4%
26/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
12.8%
11/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Headache (Days 0-3)
|
27.8%
161/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
30.9%
60/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
31.4%
27/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Fatigue (Days 0-7)
|
29.7%
172/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
32.0%
62/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
31.4%
27/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Fever/Orally (Days 0-7)
|
7.1%
41/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
8.2%
16/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
8.1%
7/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Gastrointestinal (Days 0-7)
|
18.8%
109/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
16.5%
32/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
17.4%
15/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
|
General disorders
Headache (Days 0-7)
|
33.0%
191/579 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
37.1%
72/194 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
34.9%
30/86 • Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
|
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