Trial Outcomes & Findings for Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects (NCT NCT00514904)
NCT ID: NCT00514904
Last Updated: 2020-10-27
Results Overview
Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1504 participants
Primary outcome timeframe
One month after vaccination (Post-vaccination, study Month 1)
Results posted on
2020-10-27
Participant Flow
A total of 1504 subjects were enrolled into the study, and 1501 of them were vaccinated.
Participant milestones
| Measure |
Nimenrix Group
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Overall Study
STARTED
|
1125
|
376
|
|
Overall Study
COMPLETED
|
1101
|
371
|
|
Overall Study
NOT COMPLETED
|
24
|
5
|
Reasons for withdrawal
| Measure |
Nimenrix Group
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
21
|
3
|
Baseline Characteristics
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
Baseline characteristics by cohort
| Measure |
Nimenrix Group
n=1125 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=376 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
Total
n=1501 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.6 Years
STANDARD_DEVIATION 2.49 • n=5 Participants
|
5.5 Years
STANDARD_DEVIATION 2.45 • n=7 Participants
|
5.57 Years
STANDARD_DEVIATION 2.48 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
526 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
701 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
599 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
800 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/ South Asian heritage, n(%)
|
300 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese heritage, n(%)
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian heritage, n(%)
|
597 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
796 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander, n(%)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/ North African heritage, n(%)
|
221 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian/ European heritage, n(%)
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after vaccination (Post-vaccination, study Month 1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
Outcome measures
| Measure |
Nimenrix Group
n=723 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=240 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
rSBA-MenC
|
664 Participants
|
210 Participants
|
|
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
rSBA-MenW-135
|
673 Participants
|
195 Participants
|
|
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
rSBA-MenA
|
529 Participants
|
124 Participants
|
|
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
rSBA-MenY
|
670 Participants
|
165 Participants
|
PRIMARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Grade 3 symptom was defined as symptom that prevented normal, everyday activities.
Outcome measures
| Measure |
Nimenrix Group
n=1125 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=376 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)
|
10 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre vaccination (Month 0) and post vaccination (Month 1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.
Outcome measures
| Measure |
Nimenrix Group
n=742 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=250 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenA ≥ 1:128, M0
|
476 Participants
|
155 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenA≥ 1:128, M1
|
739 Participants
|
246 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenC≥ 1:8, M0
|
224 Participants
|
77 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenC≥ 1:8, M1
|
738 Participants
|
241 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenC ≥ 1:128 M0
|
157 Participants
|
51 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenW-135 ≥ 1:8, M0
|
455 Participants
|
152 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenW-135 ≥ 1:8, M1
|
742 Participants
|
245 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenW-135. ≥ 1:128 M0
|
389 Participants
|
133 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenA ≥ 1:8, M0
|
491 Participants
|
162 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenA≥ 1:8, M1
|
739 Participants
|
246 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenC ≥ 1:128 M1
|
736 Participants
|
234 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenW-135 ≥ 1:128 M1
|
742 Participants
|
245 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenY ≥ 1:8, M0
|
630 Participants
|
198 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenY ≥ 1:8, M1
|
742 Participants
|
248 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenY≥ 1:128 M0
|
590 Participants
|
188 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
rSBA-MenY ≥ 1:128 M1
|
742 Participants
|
246 Participants
|
SECONDARY outcome
Timeframe: Pre vaccination (Month 0) and post vaccination (Month 1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
Antibody titers were expressed as geometric mean titers (GMTs).
Outcome measures
| Measure |
Nimenrix Group
n=742 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=250 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenA, M0
|
219.1 Titer
Interval 186.5 to 257.4
|
227.7 Titer
Interval 172.9 to 299.9
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenA, M1
|
6343.3 Titer
Interval 5998.3 to 6708.1
|
2283.2 Titer
Interval 2022.6 to 2577.3
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenC, M0
|
14.5 Titer
Interval 12.5 to 16.7
|
14.2 Titer
Interval 11.1 to 18.1
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenC, M1
|
4813.1 Titer
Interval 4342.1 to 5335.3
|
1317 Titer
Interval 1042.9 to 1663.3
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenW-135, M0
|
80.1 Titer
Interval 67.4 to 95.3
|
68.8 Titer
Interval 51.3 to 92.3
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenW-135, M1
|
11543.2 Titer
Interval 10872.7 to 12255.1
|
2157.8 Titer
Interval 1815.2 to 2565.1
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenY, M0
|
310 Titer
Interval 268.8 to 357.3
|
241.7 Titer
Interval 185.3 to 315.3
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenY, M1
|
10825.1 Titer
Interval 10232.7 to 11451.7
|
2613.1 Titer
Interval 2236.9 to 3052.5
|
SECONDARY outcome
Timeframe: Pre vaccination (Month 0) and post vaccination (Month 1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively.
Outcome measures
| Measure |
Nimenrix Group
n=743 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=250 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-TT ≥ 0.1 IU/mL, M0
|
635 Participants
|
220 Participants
|
|
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-TT ≥ 0.1 IU/mL, M1
|
733 Participants
|
218 Participants
|
|
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-TT ≥ 1.0 IU/mL, M0
|
296 Participants
|
107 Participants
|
|
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-TT ≥1.0 IU/mL, M1
|
720 Participants
|
107 Participants
|
SECONDARY outcome
Timeframe: Pre vaccination (Month 0) and post vaccination (Month 1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
Antibody concentrations were expressed as geometric mean concentrations (GMCs)
Outcome measures
| Measure |
Nimenrix Group
n=743 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=250 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Anti-TT, M0
|
0.65 Titer
Interval 0.577 to 0.731
|
0.744 Titer
Interval 0.609 to 0.908
|
|
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Anti-TT, M1
|
21.731 Titer
Interval 19.821 to 23.825
|
0.709 Titer
Interval 0.581 to 0.866
|
SECONDARY outcome
Timeframe: Pre vaccination (Month 0) and post vaccination, (Month 1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.
Outcome measures
| Measure |
Nimenrix Group
n=370 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=128 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSW-135 ≥ 2.0 μg/mL M0
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSW-135 ≥ 2.0 μg/mL M1
|
353 Participants
|
112 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSA ≥ 0.3 μg/mL, M0
|
154 Participants
|
41 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSA ≥ 0.3 μg/mL, M1
|
369 Participants
|
126 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSA ≥ 2.0 μg/mL, M0
|
59 Participants
|
12 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSA ≥ 2.0 μg/mL, M1
|
368 Participants
|
123 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSC ≥ 0.3 μg/mL, M0
|
29 Participants
|
7 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSC ≥ 0.3 μg/mL, M1
|
365 Participants
|
127 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSC ≥ 2.0 μg/mL, M0
|
12 Participants
|
2 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSC ≥ 2.0 μg/mL M1
|
363 Participants
|
125 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSW-135 ≥ 0.3 μg/mL, M0
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSW-135 ≥ 0.3 μg/mL, M1
|
368 Participants
|
121 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSY ≥ 0.3 μg/mL, M0
|
28 Participants
|
16 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSY ≥ 0.3 μg/mL, M1
|
369 Participants
|
122 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSY ≥ 2.0 μg/mL, M0
|
11 Participants
|
4 Participants
|
|
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Anti-PSY ≥ 2.0 μg/mL, M1
|
362 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: Pre vaccination (Month 0) and post vaccination (Month 1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.
Outcome measures
| Measure |
Nimenrix Group
n=370 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=128 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Anti-PSC, M1
|
22.61 μg/mL
Interval 20.24 to 25.25
|
25.69 μg/mL
Interval 21.3 to 30.99
|
|
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Anti-PSW-135, M0
|
0.17 μg/mL
Interval 0.16 to 0.18
|
0.17 μg/mL
Interval 0.16 to 0.19
|
|
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Anti-PSA, M0
|
0.4 μg/mL
Interval 0.35 to 0.46
|
0.29 μg/mL
Interval 0.24 to 0.36
|
|
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Anti-PSA, M1
|
81.1 μg/mL
Interval 71.34 to 92.2
|
25.43 μg/mL
Interval 19.66 to 32.9
|
|
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Anti-PSC, M0
|
0.18 μg/mL
Interval 0.17 to 0.19
|
0.17 μg/mL
Interval 0.15 to 0.18
|
|
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Anti-PSW-135, M1
|
12.8 μg/mL
Interval 11.32 to 14.48
|
13.85 μg/mL
Interval 10.93 to 17.53
|
|
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Anti-PSY, M0
|
0.18 μg/mL
Interval 0.17 to 0.2
|
0.2 μg/mL
Interval 0.17 to 0.23
|
|
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Anti-PSY, M1
|
19.26 μg/mL
Interval 17.1 to 21.69
|
22.71 μg/mL
Interval 18.13 to 28.46
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.
Outcome measures
| Measure |
Nimenrix Group
n=575 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=188 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms
Any Pain
|
104 Participants
|
39 Participants
|
|
Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms
Any Redness
|
82 Participants
|
31 Participants
|
|
Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms
Any Swelling
|
31 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.
Outcome measures
| Measure |
Nimenrix Group
n=542 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=186 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms
Any Pain
|
105 Participants
|
50 Participants
|
|
Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms
Any Redness
|
107 Participants
|
36 Participants
|
|
Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms
Any Swelling
|
54 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.
Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
Nimenrix Group
n=575 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=188 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects < 6 Years of Age With Solicited General Symptoms
Any Drowsiness
|
34 Participants
|
5 Participants
|
|
Number of Subjects < 6 Years of Age With Solicited General Symptoms
Fever ≥ 37.5°C
|
50 Participants
|
12 Participants
|
|
Number of Subjects < 6 Years of Age With Solicited General Symptoms
Any Irritability
|
31 Participants
|
6 Participants
|
|
Number of Subjects < 6 Years of Age With Solicited General Symptoms
Any Loss of apptite
|
35 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.
Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
Nimenrix Group
n=542 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=186 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms
Any Fatigue
|
33 Participants
|
19 Participants
|
|
Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms
Fever ≥ 37.5°C
|
48 Participants
|
19 Participants
|
|
Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms
Any Gastrointestinal
|
25 Participants
|
15 Participants
|
|
Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms
Any Headache
|
51 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to 6 months after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits.
Outcome measures
| Measure |
Nimenrix Group
n=1125 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=376 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects Reporting Specific Adverse Events (AEs)
Rash (es)
|
45 Participants
|
16 Participants
|
|
Number of Subjects Reporting Specific Adverse Events (AEs)
NOCI (s)
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Specific Adverse Events (AEs)
ER visit (s)
|
15 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to one month (Day 0-Day 30) after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Unsolicited symptom covers any symptom 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.
Outcome measures
| Measure |
Nimenrix Group
n=1125 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=376 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects Reporting Any Unsolicited Symptoms
|
198 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to 6 months after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Nimenrix Group
n=1125 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=376 Participants
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
|
15 Participants
|
7 Participants
|
Adverse Events
Nimenrix Group
Serious events: 15 serious events
Other events: 416 other events
Deaths: 0 deaths
Mencevax ACWY Group
Serious events: 7 serious events
Other events: 155 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nimenrix Group
n=1125 participants at risk
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=376 participants at risk
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.09%
1/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
1/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.27%
1/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.09%
1/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Gastrointestinal disorders
Enteritis
|
0.09%
1/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.09%
1/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Skin and subcutaneous tissue disorders
Hyperchlorhydria
|
0.09%
1/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.09%
1/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.27%
3/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.80%
3/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Typhoid fever
|
0.18%
2/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.53%
2/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
3/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.27%
1/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Dengue fever
|
0.18%
2/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Otitis media
|
0.18%
2/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Viral infection
|
0.18%
2/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Amoebic dysentery
|
0.09%
1/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.27%
1/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.09%
1/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.27%
1/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.27%
1/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
Infections and infestations
Respiratory tract infection
|
0.09%
1/1125 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
0.00%
0/376 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
Other adverse events
| Measure |
Nimenrix Group
n=1125 participants at risk
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=376 participants at risk
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
|
|---|---|---|
|
General disorders
Pain (< 6 years of age)
|
18.1%
104/575 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
20.7%
39/188 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Redness (< 6 years of age)
|
14.3%
82/575 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
16.5%
31/188 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Swelling (< 6 years of age)
|
5.4%
31/575 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
8.0%
15/188 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Pain (≥ 6 years of age)
|
18.3%
105/575 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
26.6%
50/188 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Redness (≥ 6 years of age)
|
19.7%
107/542 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
19.4%
36/186 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Swelling (≥ 6 years of age)
|
10.0%
54/542 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
8.6%
16/186 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Drowsiness
|
5.9%
34/575 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
2.7%
5/188 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Fever (Orally) (< 6 years of age)
|
8.7%
50/575 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
6.4%
12/188 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Irritability
|
5.4%
31/575 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
3.2%
6/188 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Loss of appetite
|
6.1%
35/575 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
3.2%
6/188 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Fatigue
|
6.1%
33/542 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
10.2%
19/186 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Fever (Orally) (≥ 6 years of age)
|
8.9%
48/542 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
10.2%
19/186 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Gastrointestinal
|
4.6%
25/542 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
8.1%
15/186 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
|
General disorders
Headache
|
9.4%
51/542 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
|
10.2%
19/186 • Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for 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