Trial Outcomes & Findings for Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects (NCT NCT00464815)

NCT ID: NCT00464815

Last Updated: 2018-06-08

Results Overview

Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative \[rSBA titer below (\<) 1:8\] and as a 4-fold increase in titer in subjects initially seropositive \[rSBA titer greater than or equal to (≥) 1:8\].

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1025 participants
• Primary outcome timeframe: One month post-vaccination (At Month 1)
• Results posted on: 2018-06-08

Participant Flow

The target sample size was 1024 enrolled subjects, but a total of 1025 subjects (in all age strata) were actually enrolled and vaccinated in seven study centres in India, Taiwan and the Philippines.

Participant milestones

Measure	Nimenrix Group Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Overall Study STARTED	768	257
Overall Study COMPLETED	762	254
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Measure	Nimenrix Group Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Overall Study Withdrawal by Subject	6	3

Baseline Characteristics

Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects

Baseline characteristics by cohort

Measure	Nimenrix Group n=768 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=257 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.	Total n=1025 Participants Total of all reporting groups
Age, Continuous	14.3 Years STANDARD_DEVIATION 1.97 • n=5 Participants	14.3 Years STANDARD_DEVIATION 1.97 • n=7 Participants	14.3 Years STANDARD_DEVIATION 1.97 • n=5 Participants
Sex: Female, Male Female	414 Participants n=5 Participants	135 Participants n=7 Participants	549 Participants n=5 Participants
Sex: Female, Male Male	354 Participants n=5 Participants	122 Participants n=7 Participants	476 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-Central/South Asian heritage	296 Participants n=5 Participants	100 Participants n=7 Participants	396 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-East Asian heritage	175 Participants n=5 Participants	59 Participants n=7 Participants	234 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-South East Asian heritage	297 Participants n=5 Participants	98 Participants n=7 Participants	395 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month post-vaccination (At Month 1)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.

Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].

Outcome measures

Measure	Nimenrix Group n=657 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=219 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Number of Subjects With Vaccine Response to Meningococcal Antigens rSBA-MenA	472 Participants	148 Participants
Number of Subjects With Vaccine Response to Meningococcal Antigens rSBA-MenC	625 Participants	204 Participants
Number of Subjects With Vaccine Response to Meningococcal Antigens rSBA-MenW-135	616 Participants	189 Participants
Number of Subjects With Vaccine Response to Meningococcal Antigens rSBA-MenY	616 Participants	172 Participants

PRIMARY outcome

Timeframe: During the 4-day (Days 0-3) period after vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).

Outcome measures

Measure	Nimenrix Group n=768 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=257 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms	12 Participants	1 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and 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 for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.

Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.

Outcome measures

Measure	Nimenrix Group n=678 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=224 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenA, Month 0 ≥ 1:8	463 Participants	148 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenA, Month 0 ≥ 1:128	427 Participants	128 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenA, Month 1 ≥ 1:8	674 Participants	223 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenA, Month 1 ≥ 1:128	674 Participants	223 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenC, Month 0 ≥ 1:8	381 Participants	121 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenC, Month 0 ≥ 1:128	277 Participants	79 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenC, Month 1 ≥ 1:8	673 Participants	224 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenC, Month 1 ≥ 1:128	672 Participants	223 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA- MenW-135, Month 0 ≥ 1:8	519 Participants	176 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA- MenW-135, Month 0 ≥ 1:128	373 Participants	120 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA- MenW-135, Month 1 ≥ 1:8	677 Participants	224 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA- MenW-135, Month 1 ≥ 1:128	677 Participants	223 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenY, Month 0 ≥ 1:8	597 Participants	186 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenY, Month 0 ≥ 1:128	538 Participants	167 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenY, Month 1 ≥ 1:8	677 Participants	224 Participants
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values rSBA-MenY, Month 1 ≥ 1:128	677 Participants	224 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and 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 for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Measure	Nimenrix Group n=678 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=224 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Meningococcal rSBA Antibody Titers rSBA-MenA, Month 0	208.1 Titer Interval 176.4 to 245.5	155.9 Titer Interval 113.8 to 213.7
Meningococcal rSBA Antibody Titers rSBA-MenA, Month 1	5928.5 Titer Interval 5557.4 to 6324.3	2947.2 Titer Interval 2611.7 to 3325.7
Meningococcal rSBA Antibody Titers rSBA-MenC, Month 0	44.1 Titer Interval 37.3 to 52.2	40.9 Titer Interval 30.2 to 55.3
Meningococcal rSBA Antibody Titers rSBA-MenC, Month 1	13109.8 Titer Interval 11939.1 to 14395.2	8222 Titer Interval 6807.5 to 9930.4
Meningococcal rSBA Antibody Titers rSBA- MenW-135, Month 0	109.4 Titer Interval 94.6 to 126.6	112.2 Titer Interval 87.2 to 144.3
Meningococcal rSBA Antibody Titers rSBA- MenW-135, Month 1	8246.6 Titer Interval 7638.8 to 8902.7	2632.7 Titer Interval 2299.3 to 3014.4
Meningococcal rSBA Antibody Titers rSBA-MenY, Month 0	348.3 Titer Interval 303.5 to 399.7	299 Titer Interval 225.2 to 397.0
Meningococcal rSBA Antibody Titers rSBA-MenY, Month 1	14086.5 Titer Interval 13168.0 to 15069.0	5066.3 Titer Interval 4463.1 to 5750.9

SECONDARY outcome

Timeframe: Prior to (Month 0) and 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 for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.

The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).

Outcome measures

Measure	Nimenrix Group n=679 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=224 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value Anti-TT, Month 0	439 Participants	155 Participants
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value Anti-TT, Month 1	662 Participants	157 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and 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 for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.

Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Outcome measures

Measure	Nimenrix Group n=679 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=224 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Anti-TT Antibody Concentrations Anti-TT, Month 0	0.367 IU/mL Interval 0.321 to 0.419	0.41 IU/mL Interval 0.326 to 0.516
Anti-TT Antibody Concentrations Anti-TT, Month 1	10.305 IU/mL Interval 9.131 to 11.631	0.459 IU/mL Interval 0.364 to 0.58

SECONDARY outcome

Timeframe: Prior to (Month 0) and 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 for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.

The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.

Outcome measures

Measure	Nimenrix Group n=347 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=114 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSA ≥ 0.3 ug/mL, Month 0	235 Participants	75 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSA ≥ 0.3 ug/mL, Month 1	341 Participants	107 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSC ≥ 0.3 ug/mL, Month 0	50 Participants	21 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSC ≥ 0.3 ug/mL, Month 1	331 Participants	107 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSW-135 ≥ 0.3 ug/mL, Month 0	40 Participants	8 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSW-135 ≥ 0.3 ug/mL, Month 1	340 Participants	113 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSY ≥ 0.3 ug/mL, Month 0	49 Participants	16 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSY ≥ 0.3 ug/mL, Month 1	342 Participants	113 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSA ≥ 2 ug/mL, Month 0	130 Participants	40 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSA ≥ 2 ug/mL, Month 1	341 Participants	107 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSC ≥ 2 ug/mL, Month 0	17 Participants	10 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSC ≥ 2 ug/mL, Month 1	324 Participants	106 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSW-135 ≥ 2 ug/mL, Month 0	9 Participants	3 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSW-135 ≥ 2 ug/mL, Month 1	327 Participants	106 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSY ≥ 2 ug/mL, Month 0	12 Participants	8 Participants
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values Anti-PSY ≥ 2 ug/mL, Month 1	336 Participants	111 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and 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 for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

Outcome measures

Measure	Nimenrix Group n=347 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=114 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Anti-meningococcal Polysaccharide Concentrations Anti-PSC, Month 0	0.21 μg/mL Interval 0.19 to 0.24	0.25 μg/mL Interval 0.2 to 0.3
Anti-meningococcal Polysaccharide Concentrations Anti-PSA, Month 0	1.05 μg/mL Interval 0.88 to 1.24	1.04 μg/mL Interval 0.77 to 1.39
Anti-meningococcal Polysaccharide Concentrations Anti-PSA, Month 1	86.06 μg/mL Interval 75.35 to 98.29	44.06 μg/mL Interval 34.4 to 56.42
Anti-meningococcal Polysaccharide Concentrations Anti-PSC, Month 1	22.83 μg/mL Interval 20.42 to 25.52	43.24 μg/mL Interval 35.8 to 52.23
Anti-meningococcal Polysaccharide Concentrations Anti-PSW-135, Month 0	0.18 μg/mL Interval 0.17 to 0.2	0.18 μg/mL Interval 0.16 to 0.21
Anti-meningococcal Polysaccharide Concentrations Anti-PSW-135, Month 1	17.82 μg/mL Interval 15.34 to 20.7	13.22 μg/mL Interval 10.47 to 16.68
Anti-meningococcal Polysaccharide Concentrations Anti-PSY, Month 0	0.2 μg/mL Interval 0.18 to 0.22	0.22 μg/mL Interval 0.18 to 0.28
Anti-meningococcal Polysaccharide Concentrations Anti-PSY, Month 1	23.77 μg/mL Interval 20.95 to 26.98	17.97 μg/mL Interval 14.3 to 22.59

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) period after vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.

Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).

Outcome measures

Measure	Nimenrix Group n=763 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=254 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	200 Participants	68 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	6 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	94 Participants	16 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	71 Participants	16 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	9 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) period after vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.

Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	Nimenrix Group n=763 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=254 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	109 Participants	36 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	7 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	83 Participants	26 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever (Axillary)	55 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	42 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms	35 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms	24 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	102 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	5 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	81 Participants	19 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-vaccination period

Population: 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 Group n=768 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=257 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Number of Subjects With Any Unsolicited Adverse Events	72 Participants	26 Participants

SECONDARY outcome

Timeframe: Up to study end (Month 6)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Nimenrix Group n=768 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=257 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Number of Subjects With Any Serious Adverse Events (SAEs)	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to study end (Month 6)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).

Outcome measures

Measure	Nimenrix Group n=768 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=257 Participants Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Number of Subjects With Specific Adverse Events Any Rash	6 Participants	1 Participants
Number of Subjects With Specific Adverse Events Any NOCIs	0 Participants	0 Participants
Number of Subjects With Specific Adverse Events Any ER visits	1 Participants	0 Participants

Adverse Events

Nimenrix Group

Serious events: 3 serious events

Other events: 311 other events

Deaths: 0 deaths

Mencevax ACWY Group

Serious events: 2 serious events

Other events: 99 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nimenrix Group n=768 participants at risk Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix™ (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=257 participants at risk Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax™ ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	0.39% 1/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
Gastrointestinal disorders Peptic ulcer	0.26% 2/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	0.00% 0/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
Infections and infestations Amoebic dysentery	0.13% 1/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	0.00% 0/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
Infections and infestations Appendicitis	0.00% 0/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	0.39% 1/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
Infections and infestations Peritoneal abscess	0.00% 0/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	0.39% 1/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
Infections and infestations Urinary tract infection	0.13% 1/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	0.00% 0/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).

Other adverse events

Measure	Nimenrix Group n=768 participants at risk Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix™ (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.	Mencevax ACWY Group n=257 participants at risk Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax™ ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
General disorders Pain	26.0% 200/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	26.5% 68/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
General disorders Redness	12.2% 94/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	6.2% 16/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
General disorders Swelling	9.2% 71/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	6.2% 16/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
General disorders Fatigue	14.2% 109/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	14.0% 36/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
General disorders Fever	7.2% 55/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	5.1% 13/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
General disorders Headache	13.3% 102/768 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).	10.5% 27/257 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).

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