Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults (NCT NCT01165242)
NCT ID: NCT01165242
Last Updated: 2018-06-26
Results Overview
Vaccine response was defined as: * for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; * for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1013 participants
Primary outcome timeframe
One month after vaccination (Month 1)
Results posted on
2018-06-26
Participant Flow
Out of the 1013 subjects enrolled in this study, 2 were assigned subject numbers but received no vaccination and were hence excluded from the study start.
Participant milestones
| Measure |
Nimenrix Lot A Group
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix Lot B Group
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
337
|
336
|
338
|
|
Overall Study
COMPLETED
|
327
|
326
|
324
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
14
|
Reasons for withdrawal
| Measure |
Nimenrix Lot A Group
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix Lot B Group
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Overall Study
Unreachable Subjects
|
1
|
0
|
0
|
|
Overall Study
Incarcerated Subjects
|
0
|
1
|
0
|
|
Overall Study
Visit 2 Declined by Subject
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
2
|
|
Overall Study
Extended Holiday
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
10
|
Baseline Characteristics
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
Baseline characteristics by cohort
| Measure |
Nimenrix Lot A Group
n=337 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix Lot B Group
n=336 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=338 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Total
n=1011 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
16.4 Years
STANDARD_DEVIATION 5.16 • n=5 Participants
|
16.3 Years
STANDARD_DEVIATION 5.16 • n=7 Participants
|
16.2 Years
STANDARD_DEVIATION 4.97 • n=5 Participants
|
16.30 Years
STANDARD_DEVIATION 5.09 • n=4 Participants
|
|
Sex: Female, Male
Female
|
175 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
520 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
491 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · African Heritage/ African American
|
38 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · American Indian or Alaskan Native
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian-Central/ South Asian Heritage
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - East Asian Heritage
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Japanese Heritage
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - South East Asian Heritage
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Arabic/ North African Heritage
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian/ European Heritage
|
248 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
754 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Other (Mix of races, e.g. African/White)
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One month after vaccination (Month 1)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
Vaccine response was defined as: * for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; * for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
Outcome measures
| Measure |
Nimenrix Lot A Group
n=310 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=297 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies
hSBA-MenA
|
218 Participants
|
191 Participants
|
—
|
|
Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies
hSBA-MenC
|
217 Participants
|
209 Participants
|
—
|
|
Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies
hSBA-MenW-135
|
198 Participants
|
185 Participants
|
—
|
|
Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies
hSBA-MenY
|
150 Participants
|
115 Participants
|
—
|
SECONDARY outcome
Timeframe: Prior to (PRE) and one month after vaccination (Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.
The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4.
Outcome measures
| Measure |
Nimenrix Lot A Group
n=315 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=309 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=306 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenA, PRE
|
79 Participants
|
84 Participants
|
89 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenA, Month 1
|
253 Participants
|
243 Participants
|
223 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenC, PRE
|
175 Participants
|
188 Participants
|
197 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenC, Month 1
|
295 Participants
|
293 Participants
|
291 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenW-135, PRE
|
99 Participants
|
98 Participants
|
102 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenW-135, Month 1
|
272 Participants
|
262 Participants
|
247 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenY, PRE
|
215 Participants
|
224 Participants
|
234 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenY, Month 1
|
307 Participants
|
302 Participants
|
287 Participants
|
SECONDARY outcome
Timeframe: Prior to (PRE) and one month after vaccination (Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.
The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:8.
Outcome measures
| Measure |
Nimenrix Lot A Group
n=315 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=309 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=306 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenA, PRE
|
61 Participants
|
65 Participants
|
67 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenA, Month 1
|
251 Participants
|
242 Participants
|
221 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenC, PRE
|
174 Participants
|
185 Participants
|
193 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenC, Month 1
|
295 Participants
|
292 Participants
|
291 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenW-135, PRE
|
99 Participants
|
97 Participants
|
101 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenW-135, Month 1
|
272 Participants
|
262 Participants
|
247 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenY, PRE
|
215 Participants
|
223 Participants
|
234 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
hSBA-MenY, Month 1
|
307 Participants
|
302 Participants
|
287 Participants
|
SECONDARY outcome
Timeframe: Prior to (PRE) and one month after vaccination (Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.
Antibody titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Nimenrix Lot A Group
n=315 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=309 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=306 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenA, PRE
|
3.6 Titers
Interval 3.1 to 4.0
|
3.6 Titers
Interval 3.2 to 4.1
|
3.6 Titers
Interval 3.2 to 4.1
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenA, Month 1
|
54.2 Titers
Interval 43.5 to 67.4
|
49.6 Titers
Interval 39.6 to 62.1
|
41.3 Titers
Interval 32.3 to 52.9
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenC, PRE
|
15.6 Titers
Interval 12.3 to 19.9
|
16.0 Titers
Interval 12.8 to 20.0
|
18.0 Titers
Interval 14.4 to 22.6
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenC, Month 1
|
687.1 Titers
Interval 510.5 to 924.9
|
755.8 Titers
Interval 557.3 to 1025.0
|
543.3 Titers
Interval 411.2 to 718.0
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenW-135, PRE
|
7.7 Titers
Interval 6.1 to 9.7
|
7.6 Titers
Interval 6.0 to 9.6
|
7.4 Titers
Interval 5.9 to 9.2
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenW-135, Month 1
|
174.5 Titers
Interval 138.6 to 219.6
|
161.6 Titers
Interval 128.3 to 203.5
|
101.7 Titers
Interval 77.9 to 132.7
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenY, PRE
|
45.7 Titers
Interval 35.9 to 58.2
|
49.8 Titers
Interval 39.1 to 63.4
|
55.3 Titers
Interval 43.7 to 69.9
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenY, Month 1
|
349.1 Titers
Interval 298.1 to 408.8
|
387.4 Titers
Interval 329.7 to 455.1
|
253.8 Titers
Interval 204.9 to 314.5
|
SECONDARY outcome
Timeframe: One month after vaccination (Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
Vaccine response was defined as: -for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; -for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
Outcome measures
| Measure |
Nimenrix Lot A Group
n=300 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
hSBA-MenA
|
214 Participants
|
—
|
—
|
|
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
hSBA-MenC
|
226 Participants
|
—
|
—
|
|
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
hSBA-MenW-135
|
196 Participants
|
—
|
—
|
|
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
hSBA-MenY
|
150 Participants
|
—
|
—
|
SECONDARY 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, who had their symptom sheets filled in.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Outcome measures
| Measure |
Nimenrix Lot A Group
n=329 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=329 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=325 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
169 Participants
|
167 Participants
|
180 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
8 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
85 Participants
|
60 Participants
|
66 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
63 Participants
|
40 Participants
|
44 Participants
|
SECONDARY 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, who had their symptom sheets filled in.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Nimenrix Lot A Group
n=329 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=329 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=326 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
96 Participants
|
94 Participants
|
89 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
9 Participants
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
75 Participants
|
80 Participants
|
77 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal
|
43 Participants
|
43 Participants
|
44 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal
|
31 Participants
|
33 Participants
|
32 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
86 Participants
|
87 Participants
|
83 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
72 Participants
|
70 Participants
|
68 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature (Orally)
|
17 Participants
|
14 Participants
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature (Orally)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature (Orally)
|
15 Participants
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Within 31 days (Day 0-30) post-vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Nimenrix Lot A Group
n=337 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=336 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=338 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
105 Participants
|
76 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: From Month 0 through Month 6Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
NOCI included hypersensitivity, insulin resistance, asthma and bronchial hyperreactivity.
Outcome measures
| Measure |
Nimenrix Lot A Group
n=337 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=336 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=338 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With New Onset of Chronic Illness(es) (NOCI)
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Month 0 through Month 6Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Nimenrix Lot A Group
n=337 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=336 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=338 Participants
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
1 Participants
|
5 Participants
|
2 Participants
|
Adverse Events
Nimenrix Lot A Group
Serious events: 1 serious events
Other events: 232 other events
Deaths: 0 deaths
Nimenrix Lot B Group
Serious events: 5 serious events
Other events: 219 other events
Deaths: 0 deaths
Menactra Group
Serious events: 2 serious events
Other events: 234 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nimenrix Lot A Group
n=337 participants at risk
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix Lot B Group
n=336 participants at risk
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=338 participants at risk
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/337 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/336 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.30%
1/338 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Injury, poisoning and procedural complications
Post-procedural haematoma
|
0.00%
0/337 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/336 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.30%
1/338 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
1/337 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.30%
1/336 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/338 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/337 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.30%
1/336 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/338 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/337 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.60%
2/336 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/338 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/337 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.60%
2/336 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/338 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Influenza
|
0.00%
0/337 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.30%
1/336 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/338 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/337 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.30%
1/336 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/338 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
Other adverse events
| Measure |
Nimenrix Lot A Group
n=337 participants at risk
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Nimenrix Lot B Group
n=336 participants at risk
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Menactra Group
n=338 participants at risk
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
General disorders
Pain
|
51.4%
169/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
50.8%
167/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
55.4%
180/325 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Redness
|
25.8%
85/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
18.2%
60/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
20.3%
66/325 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Swelling
|
19.1%
63/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
12.2%
40/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
13.5%
44/325 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Fatigue
|
29.2%
96/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
28.6%
94/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
27.3%
89/326 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Gastrointestinal
|
13.1%
43/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
13.1%
43/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
13.5%
44/326 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Headache
|
26.1%
86/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
26.4%
87/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
25.5%
83/326 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Temperature (Orally)
|
5.2%
17/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
4.3%
14/329 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
4.9%
16/326 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER