Trial Outcomes & Findings for The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults (NCT NCT00715910)
NCT ID: NCT00715910
Last Updated: 2014-11-27
Results Overview
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
818 participants
Primary outcome timeframe
At year 1 persistence
Results posted on
2014-11-27
Participant Flow
At Year 5, subjects in Nimenrix 1, Menactra and Nimenrix 2 groups received a booster dose of Nimenrix. During booster phase, subjects in Nimenrix 1 and Nimenrix 2 groups were pooled. An additional naïve control group 15 to \< 31 years of age was enrolled at Year 5.
A total of 818 subjects were enrolled in the study. Year 1, 3 and 5 included only those subjects who came for the visits during these persistence years.
Participant milestones
| Measure |
Nimenrix 1 Group
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Nimenrix Pooled Group
Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
Menactra Booster Group
Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
Nimenrix Naïve Group
Naïve control group of subjects 15 to \< 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
|---|---|---|---|---|---|---|
|
Year 1
STARTED
|
433
|
147
|
68
|
0
|
0
|
0
|
|
Year 1
COMPLETED
|
433
|
147
|
68
|
0
|
0
|
0
|
|
Year 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 3
STARTED
|
345
|
86
|
56
|
0
|
0
|
0
|
|
Year 3
COMPLETED
|
345
|
86
|
56
|
0
|
0
|
0
|
|
Year 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 5
STARTED
|
218
|
56
|
38
|
0
|
0
|
0
|
|
Year 5
COMPLETED
|
218
|
56
|
38
|
0
|
0
|
0
|
|
Year 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Booster and ESFU Phase
STARTED
|
0
|
0
|
0
|
183
|
38
|
101
|
|
Booster and ESFU Phase
COMPLETED
|
0
|
0
|
0
|
172
|
36
|
88
|
|
Booster and ESFU Phase
NOT COMPLETED
|
0
|
0
|
0
|
11
|
2
|
13
|
Reasons for withdrawal
| Measure |
Nimenrix 1 Group
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Nimenrix Pooled Group
Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
Menactra Booster Group
Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
Nimenrix Naïve Group
Naïve control group of subjects 15 to \< 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
|---|---|---|---|---|---|---|
|
Booster and ESFU Phase
Lost to Follow-up
|
0
|
0
|
0
|
6
|
1
|
13
|
|
Booster and ESFU Phase
Other
|
0
|
0
|
0
|
5
|
1
|
0
|
Baseline Characteristics
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults
Baseline characteristics by cohort
| Measure |
Nimenrix 1 Group
n=433 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=147 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=68 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Nimenrix naïve Group
n=101 Participants
Naïve control group of subjects 15 to \< 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
Total
n=749 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
15.9 Years
STANDARD_DEVIATION 2.79 • n=5 Participants
|
16.0 Years
STANDARD_DEVIATION 2.83 • n=7 Participants
|
11.2 Years
STANDARD_DEVIATION 0.42 • n=5 Participants
|
23.3 Years
STANDARD_DEVIATION 4.74 • n=4 Participants
|
16.5 Years
STANDARD_DEVIATION 4.26 • n=21 Participants
|
|
Sex: Female, Male
Female
|
213 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
397 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
220 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
352 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At year 1 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Outcome measures
| Measure |
Nimenrix 1 Group
n=356 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=112 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=58 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values
hSBA-MenA [N=350;111;57]
|
102 Subjects
|
35 Subjects
|
15 Subjects
|
|
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values
hSBA-MenC [N=336;105;56]
|
319 Subjects
|
77 Subjects
|
55 Subjects
|
|
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values
hSBA-MenW-135 [N=327;107;54]
|
322 Subjects
|
81 Subjects
|
53 Subjects
|
|
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values
hSBA-MenY [N=356;112;58]
|
348 Subjects
|
97 Subjects
|
58 Subjects
|
PRIMARY outcome
Timeframe: At year 3 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Outcome measures
| Measure |
Nimenrix 1 Group
n=321 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=80 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=53 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenA [N=314;78;51]
|
117 Subjects
|
37 Subjects
|
22 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenC [N=317;80;53]
|
295 Subjects
|
65 Subjects
|
51 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenW-135 [N=321;79;53]
|
306 Subjects
|
67 Subjects
|
51 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenY [N=319;79;51]
|
306 Subjects
|
70 Subjects
|
49 Subjects
|
PRIMARY outcome
Timeframe: At year 5 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Outcome measures
| Measure |
Nimenrix 1 Group
n=142 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=45 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=26 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenA [N=141;45;24]
|
69 Subjects
|
20 Subjects
|
9 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenC [N=140;44;26]
|
130 Subjects
|
35 Subjects
|
22 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenW-135 [N=138;44;26]
|
120 Subjects
|
37 Subjects
|
24 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenY [N=142;44;26]
|
134 Subjects
|
40 Subjects
|
24 Subjects
|
SECONDARY outcome
Timeframe: At year 1 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Outcome measures
| Measure |
Nimenrix 1 Group
n=356 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=112 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=58 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenA [N=350;111;57]
|
106 Subjects
|
35 Subjects
|
17 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenC [N=336;105;56]
|
319 Subjects
|
77 Subjects
|
55 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenW-135 [N=327;107;54]
|
322 Subjects
|
81 Subjects
|
54 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenY [N=356;112;58]
|
348 Subjects
|
97 Subjects
|
58 Subjects
|
SECONDARY outcome
Timeframe: At year 3 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Outcome measures
| Measure |
Nimenrix 1 Group
n=321 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=80 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=53 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenA [N=314;78;51]
|
123 Subjects
|
37 Subjects
|
23 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenC [N=317;80;53]
|
295 Subjects
|
68 Subjects
|
51 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenW-135 [N=321;79;53]
|
307 Subjects
|
67 Subjects
|
52 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenY [N=319;79;51]
|
306 Subjects
|
70 Subjects
|
49 Subjects
|
SECONDARY outcome
Timeframe: At year 5 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Outcome measures
| Measure |
Nimenrix 1 Group
n=142 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=45 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=26 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenA [N=141;45;24]
|
74 Subjects
|
20 Subjects
|
9 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenC [N=140;44;26]
|
134 Subjects
|
39 Subjects
|
24 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenW-135 [N=138;44;26]
|
122 Subjects
|
37 Subjects
|
24 Subjects
|
|
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA-MenY [N=142;44;26]
|
134 Subjects
|
40 Subjects
|
24 Subjects
|
SECONDARY outcome
Timeframe: At year 1 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Outcome measures
| Measure |
Nimenrix 1 Group
n=356 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=112 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=58 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
hSBA Antibody Titers
hSBA-MenA titers [N=350;111;57]
|
5.4 Titers
Interval 4.5 to 6.4
|
6.0 Titers
Interval 4.3 to 8.5
|
5.2 Titers
Interval 3.4 to 7.9
|
|
hSBA Antibody Titers
hSBA-MenC titers [N=336;105;56]
|
172.0 Titers
Interval 142.5 to 207.4
|
46.7 Titers
Interval 30.2 to 72.1
|
238.3 Titers
Interval 154.0 to 368.9
|
|
hSBA Antibody Titers
hSBA-MenW-135 titers [N=327;107;54]
|
197.5 Titers
Interval 173.0 to 225.5
|
48.9 Titers
Interval 32.5 to 73.8
|
231.2 Titers
Interval 174.5 to 306.2
|
|
hSBA Antibody Titers
hSBA-MenY titers [N=356;112;58]
|
271.8 Titers
Interval 237.5 to 311.2
|
100.8 Titers
Interval 69.6 to 146.2
|
266.8 Titers
Interval 205.1 to 347.0
|
SECONDARY outcome
Timeframe: At year 3 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Outcome measures
| Measure |
Nimenrix 1 Group
n=321 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=80 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=53 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
hSBA Antibody Titers
hSBA-MenA titers [N=314;78;51]
|
6.2 Titers
Interval 5.2 to 7.3
|
9.3 Titers
Interval 6.2 to 14.0
|
8.8 Titers
Interval 5.3 to 14.9
|
|
hSBA Antibody Titers
hSBA-MenC titers [N=317;80;53]
|
117.9 Titers
Interval 94.3 to 147.4
|
54.8 Titers
Interval 33.9 to 88.9
|
131.2 Titers
Interval 79.8 to 215.7
|
|
hSBA Antibody Titers
hSBA-MenW-135 titers [N=321;79;53]
|
141.6 Titers
Interval 122.8 to 163.4
|
75.5 Titers
Interval 48.7 to 117.0
|
137.6 Titers
Interval 98.2 to 192.9
|
|
hSBA Antibody Titers
hSBA-MenY titers [N=319;79;51]
|
206.6 Titers
Interval 177.9 to 239.8
|
139.0 Titers
Interval 93.8 to 206.2
|
186.6 Titers
Interval 130.7 to 266.6
|
SECONDARY outcome
Timeframe: At year 5 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Outcome measures
| Measure |
Nimenrix 1 Group
n=142 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=45 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=26 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
hSBA Antibody Titers
hSBA-MenA titers [N=141;45;24]
|
8.9 Titers
Interval 6.8 to 11.8
|
7.9 Titers
Interval 4.8 to 13.2
|
6.3 Titers
Interval 3.2 to 12.2
|
|
hSBA Antibody Titers
hSBA-MenC titers [N=140;44;26]
|
94.6 Titers
Interval 65.9 to 135.9
|
30.6 Titers
Interval 17.3 to 54.4
|
92.9 Titers
Interval 39.6 to 217.6
|
|
hSBA Antibody Titers
hSBA-MenW-135 titers [N=138;44;26]
|
103.5 Titers
Interval 76.3 to 140.5
|
70.4 Titers
Interval 37.2 to 133.1
|
92.4 Titers
Interval 50.5 to 168.8
|
|
hSBA Antibody Titers
hSBA-MenY titers [N=142;44;26]
|
224.6 Titers
Interval 173.9 to 290.0
|
129.3 Titers
Interval 77.4 to 215.9
|
113.7 Titers
Interval 58.4 to 221.3
|
SECONDARY outcome
Timeframe: At year 1 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.
Outcome measures
| Measure |
Nimenrix 1 Group
n=366 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=112 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=59 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
Anti-PSA ≥ 0.3 µg/mL [N=355;112;56]
|
340 Subjects
|
101 Subjects
|
55 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
Anti-PSA ≥ 2.0 µg/mL [N=355;112;56]
|
260 Subjects
|
66 Subjects
|
38 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
Anti-PSC ≥ 0.3 µg/mL [N=366;112;58]
|
302 Subjects
|
56 Subjects
|
51 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
Anti-PSC ≥ 2.0 µg/mL [N=366;112;58]
|
162 Subjects
|
31 Subjects
|
28 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
Anti-PSW-135 ≥ 0.3 µg/mL [N=354;104;56]
|
319 Subjects
|
65 Subjects
|
54 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
Anti-PSW-135 ≥ 2.0 µg/mL [N=354;104;56]
|
178 Subjects
|
27 Subjects
|
28 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
Anti-PSY ≥ 0.3 µg/mL [N=358;112;59]
|
342 Subjects
|
78 Subjects
|
55 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
Anti-PSY ≥ 2.0 µg/mL [N=358;112;59]
|
240 Subjects
|
38 Subjects
|
37 Subjects
|
SECONDARY outcome
Timeframe: At year 1 persistencePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.
Outcome measures
| Measure |
Nimenrix 1 Group
n=366 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=112 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=59 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations
Anti-PSA [N=355;112;56]
|
5.0 μg/mL
Interval 4.2 to 5.9
|
3.7 μg/mL
Interval 2.6 to 5.3
|
4.2 μg/mL
Interval 2.9 to 6.1
|
|
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations
Anti-PSC [N=366;112;58]
|
1.8 μg/mL
Interval 1.5 to 2.1
|
0.6 μg/mL
Interval 0.5 to 0.9
|
2.1 μg/mL
Interval 1.4 to 3.1
|
|
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations
Anti-PSW-135 [N=354;104;56]
|
2.0 μg/mL
Interval 1.7 to 2.3
|
0.8 μg/mL
Interval 0.6 to 1.1
|
2.0 μg/mL
Interval 1.5 to 2.6
|
|
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations
Anti-PSY [N=358;112;59]
|
3.4 μg/mL
Interval 3.0 to 4.0
|
1.0 μg/mL
Interval 0.7 to 1.3
|
2.5 μg/mL
Interval 1.8 to 3.4
|
SECONDARY outcome
Timeframe: From 6 months up to 1 year following primary vaccinationPopulation: Analysis was performed on Total cohort at Year 1 which included all subjects vaccinated in the primary study and who came back to the visit at Year 1.
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 1 Group
n=433 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=147 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=68 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: From 6 months up to 3 years following primary vaccinationPopulation: Analysis was performed on Total cohort at Year 3 which included all subjects vaccinated in the primary study and who came back to the visit at Year 3.
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 1 Group
n=345 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=86 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=56 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: From 6 months up to 5 years following primary vaccinationPopulation: Analysis was performed on Total cohort at Year 5 which included all subjects vaccinated in the primary study and who came back to the visit at Year 5.
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 1 Group
n=218 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=56 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=38 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: 1 month post primary (naïve control group) and booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.
The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.
Outcome measures
| Measure |
Nimenrix 1 Group
n=109 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=29 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=84 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenA ≥ 1:4 [N=106;28;79]
|
105 Subjects
|
28 Subjects
|
61 Subjects
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenA ≥ 1:8 [N=106;28;79]
|
105 Subjects
|
28 Subjects
|
61 Subjects
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenC ≥ 1:4 [N=109;29;81]
|
108 Subjects
|
29 Subjects
|
78 Subjects
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenC ≥ 1:8 [N=109;29;81]
|
108 Subjects
|
29 Subjects
|
77 Subjects
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenW-135 ≥ 1:4 [N=109;29;80]
|
109 Subjects
|
29 Subjects
|
74 Subjects
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenW-135 ≥ 1:8 [N=109;29;80]
|
109 Subjects
|
29 Subjects
|
74 Subjects
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenY ≥ 1:4 [N=109;29;84]
|
109 Subjects
|
29 Subjects
|
82 Subjects
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenY ≥ 1:8 [N=109;29;84]
|
109 Subjects
|
29 Subjects
|
82 Subjects
|
SECONDARY outcome
Timeframe: 1 month post primary (naïve control group) and booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.
Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Outcome measures
| Measure |
Nimenrix 1 Group
n=109 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=29 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=84 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
hSBA Antibody Titers
hSBA-MenA Titers [N=106;28;79]
|
783.8 Titers
Interval 601.7 to 1020.9
|
952.0 Titers
Interval 600.9 to 1508.2
|
79.7 Titers
Interval 46.3 to 137.4
|
|
hSBA Antibody Titers
hSBA-MenC Titers [N=109;29;81]
|
5020.4 Titers
Interval 3995.4 to 6308.4
|
6722.1 Titers
Interval 3950.9 to 11437.2
|
534.7 Titers
Interval 308.0 to 928.1
|
|
hSBA Antibody Titers
hSBA-MenW-135 Titers [N=109;29;80]
|
5517.6 Titers
Interval 4573.6 to 6656.4
|
3729.0 Titers
Interval 2415.4 to 5757.1
|
237.7 Titers
Interval 150.4 to 375.8
|
|
hSBA Antibody Titers
hSBA-MenY Titers [N=109;29;84]
|
5664.3 Titers
Interval 4590.0 to 6990.1
|
6546.4 Titers
Interval 4312.3 to 9938.0
|
755.1 Titers
Interval 522.4 to 1091.4
|
SECONDARY outcome
Timeframe: 1 month post primary (naïve control group) and booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.
Vaccine response was defined as: For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination.
Outcome measures
| Measure |
Nimenrix 1 Group
n=106 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=29 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=78 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
hSBA-MenA [N=101;28;75]
|
98 Subjects
|
24 Subjects
|
51 Subjects
|
|
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
hSBA-MenC [N=106;28;68]
|
97 Subjects
|
27 Subjects
|
47 Subjects
|
|
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
hSBA-MenW-135 [N=105;28;76]
|
101 Subjects
|
24 Subjects
|
51 Subjects
|
|
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
hSBA-MenY [N=106;29;78]
|
97 Subjects
|
27 Subjects
|
53 Subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
Outcome measures
| Measure |
Nimenrix 1 Group
n=170 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=37 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=91 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Any Pain
|
100 Subjects
|
20 Subjects
|
55 Subjects
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain
|
6 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness
|
39 Subjects
|
6 Subjects
|
17 Subjects
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling
|
27 Subjects
|
5 Subjects
|
14 Subjects
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Outcome measures
| Measure |
Nimenrix 1 Group
n=170 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=37 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=91 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue
|
58 Subjects
|
7 Subjects
|
30 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue
|
3 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue
|
57 Subjects
|
6 Subjects
|
29 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Any Gastrointestinal symptoms
|
28 Subjects
|
8 Subjects
|
20 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Gastrointestinal symptoms
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Related Gastrointestinal symptoms
|
28 Subjects
|
8 Subjects
|
17 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Any Headache
|
61 Subjects
|
10 Subjects
|
22 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Related Headache
|
60 Subjects
|
10 Subjects
|
21 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature
|
4 Subjects
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.
Unsolicited AE covers any AE 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 1 Group
n=183 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=38 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=101 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
40 Subjects
|
9 Subjects
|
16 Subjects
|
SECONDARY outcome
Timeframe: During the 6-month period following the primary (naïve control group) and booster vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.
Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.
Outcome measures
| Measure |
Nimenrix 1 Group
n=183 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=38 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=101 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the 6-month period following the primary (naïve control group) and booster vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.
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 1 Group
n=183 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=38 Participants
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=101 Participants
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
|---|---|---|---|
|
Number of Subjects With SAEs
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
Adverse Events
Nimenrix 1 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Menactra Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nimenrix 2 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nimenrix Pooled Group
Serious events: 3 serious events
Other events: 100 other events
Deaths: 0 deaths
Menactra Booster Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Nimenrix Naïve Group
Serious events: 0 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nimenrix 1 Group
n=433 participants at risk
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=147 participants at risk
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=68 participants at risk
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Nimenrix Pooled Group
n=183 participants at risk
Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
Menactra Booster Group
n=38 participants at risk
Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
Nimenrix Naïve Group
n=101 participants at risk
Naïve control group of subjects 15 to \<31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.55%
1/183 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/38 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/101 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Psychiatric disorders
Depression
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.55%
1/183 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/38 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/101 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Malaria
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.55%
1/183 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/38 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/101 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
Other adverse events
| Measure |
Nimenrix 1 Group
n=433 participants at risk
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Menactra Group
n=147 participants at risk
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
|
Nimenrix 2 Group
n=68 participants at risk
Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
|
Nimenrix Pooled Group
n=183 participants at risk
Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
Menactra Booster Group
n=38 participants at risk
Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
Nimenrix Naïve Group
n=101 participants at risk
Naïve control group of subjects 15 to \<31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
|
|---|---|---|---|---|---|---|
|
General disorders
Headache
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
35.9%
61/170 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
27.0%
10/37 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
24.2%
22/91 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
1.6%
3/183 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
5.3%
2/38 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/101 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Pain
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
58.8%
100/170 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
54.1%
20/37 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
60.4%
55/91 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Redness
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
22.9%
39/170 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
16.2%
6/37 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
18.7%
17/91 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Swelling
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
15.9%
27/170 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
13.5%
5/37 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
15.4%
14/91 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Fatigue
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
34.1%
58/170 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
18.9%
7/37 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
33.0%
30/91 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Gastrointestinal symptoms
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
—
0/0 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
16.5%
28/170 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
21.6%
8/37 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
22.0%
20/91 • SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER