Trial Outcomes & Findings for Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age. (NCT NCT01682876)

Last Updated: 2019-06-14

Results Overview

Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

715 participants

Primary outcome timeframe

One Month After Last Vaccination ( day 86)

Results posted on

2019-06-14

Participant Flow

Subjects were enrolled at 22 locations

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	2 Through 5 Years (2 Vac) Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) Subjects 6-10 years of age received one MenACWY-CRM vaccination
Overall Study STARTED	176	183	180	176
Overall Study COMPLETED	155	163	169	157
Overall Study NOT COMPLETED	21	20	11	19

Reasons for withdrawal

Reasons for withdrawal
Measure	2 Through 5 Years (2 Vac) Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) Subjects 6-10 years of age received one MenACWY-CRM vaccination
Overall Study Administrative reason	4	4	0	3
Overall Study Adverse Event	0	0	0	1
Overall Study Lost to Follow-up	11	15	9	11
Overall Study Protocol Violation	1	1	1	1
Overall Study Withdrawal by Subject	4	0	0	2
Overall Study Other	1	0	1	1

Baseline Characteristics

Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2 Through 5 Years (2 Vac) n=176 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=183 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=180 Participants Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=176 Participants Subjects 6-10 years of age received one MenACWY-CRM vaccination	Total n=715 Participants Total of all reporting groups
Age, Continuous	3.5 year STANDARD_DEVIATION 1.1 • n=5 Participants	3.6 year STANDARD_DEVIATION 1.2 • n=7 Participants	7.8 year STANDARD_DEVIATION 1.4 • n=5 Participants	7.8 year STANDARD_DEVIATION 1.4 • n=4 Participants	5.7 year STANDARD_DEVIATION 2.5 • n=21 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	88 Participants n=7 Participants	97 Participants n=5 Participants	87 Participants n=4 Participants	356 Participants n=21 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	95 Participants n=7 Participants	83 Participants n=5 Participants	89 Participants n=4 Participants	359 Participants n=21 Participants

PRIMARY outcome

Timeframe: One Month After Last Vaccination ( day 86)

Population: Analysis was done on the primary per-protocol (PP) dataset, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.

Outcome measures

Outcome measures
Measure	2 Through 5 Years (2 Vac) n=136 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=144 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=153 Participants Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=142 Participants Subjects 6-10 years of age received one MenACWY-CRM vaccination
Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination MenA(N=135,143,152,142)	94 percentage of subjects Interval 89.0 to 97.0	75 percentage of subjects Interval 67.0 to 82.0	89 percentage of subjects Interval 83.0 to 93.0	77 percentage of subjects Interval 70.0 to 84.0
Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination MenC(N=131,140,149,142)	92 percentage of subjects Interval 86.0 to 96.0	65 percentage of subjects Interval 56.0 to 73.0	93 percentage of subjects Interval 87.0 to 96.0	73 percentage of subjects Interval 65.0 to 80.0
Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination MenW(N=128,135,148,138)	75 percentage of subjects Interval 67.0 to 82.0	61 percentage of subjects Interval 52.0 to 69.0	58 percentage of subjects Interval 50.0 to 66.0	54 percentage of subjects Interval 45.0 to 62.0
Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination MenY(N=128,133,148,142)	91 percentage of subjects Interval 84.0 to 95.0	64 percentage of subjects Interval 55.0 to 72.0	89 percentage of subjects Interval 83.0 to 94.0	60 percentage of subjects Interval 51.0 to 68.0

PRIMARY outcome

Timeframe: One Month After Last Vaccination (day 86)

Population: Analysis was done on the FAS dataset - All subjects in the exposed dataset who provided evaluable serum samples whose assay results were available for at least 1 serogroup on day 1 and 1 post baseline visit.

Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.

Outcome measures

Outcome measures
Measure	2 Through 5 Years (2 Vac) n=159 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=165 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=172 Participants Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=163 Participants Subjects 6-10 years of age received one MenACWY-CRM vaccination
Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination MenA(N=158,163,171,163)	95 percentage of subjects Interval 90.0 to 98.0	77 percentage of subjects Interval 69.0 to 83.0	89 percentage of subjects Interval 84.0 to 94.0	79 percentage of subjects Interval 71.0 to 85.0
Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination MenC(N=154,157,167,162)	93 percentage of subjects Interval 88.0 to 96.0	65 percentage of subjects Interval 57.0 to 72.0	93 percentage of subjects Interval 89.0 to 97.0	75 percentage of subjects Interval 68.0 to 82.0
Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination MenW(N=150,154,167,159)	75 percentage of subjects Interval 68.0 to 82.0	61 percentage of subjects Interval 53.0 to 69.0	57 percentage of subjects Interval 49.0 to 65.0	52 percentage of subjects Interval 44.0 to 60.0
Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination MenY(N=150,153,167,163)	90 percentage of subjects Interval 84.0 to 94.0	62 percentage of subjects Interval 54.0 to 70.0	89 percentage of subjects Interval 83.0 to 93.0	60 percentage of subjects Interval 52.0 to 68.0

SECONDARY outcome

Timeframe: One Month After Last Vaccination (day 86)

Population: Analysis was done on the primary PP dataset.

Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.

Outcome measures

Outcome measures
Measure	2 Through 5 Years (2 Vac) n=136 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=144 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=153 Participants Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=142 Participants Subjects 6-10 years of age received one MenACWY-CRM vaccination
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM MenA(N=135,143,152,142)	95 percentage of subjects Interval 90.0 to 98.0	76 percentage of subjects Interval 68.0 to 82.0	91 percentage of subjects Interval 85.0 to 95.0	80 percentage of subjects Interval 73.0 to 86.0
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM MenC(N=131,140,149,142)	98 percentage of subjects Interval 95.0 to 100.0	76 percentage of subjects Interval 68.0 to 83.0	99 percentage of subjects Interval 95.0 to 100.0	89 percentage of subjects Interval 82.0 to 93.0
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM MenW(N=128,135,148,138)	99 percentage of subjects Interval 96.0 to 100.0	92 percentage of subjects Interval 86.0 to 96.0	99 percentage of subjects Interval 96.0 to 100.0	96 percentage of subjects Interval 91.0 to 98.0
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM MenY(N=128,133,148,142)	96 percentage of subjects Interval 91.0 to 99.0	69 percentage of subjects Interval 61.0 to 77.0	96 percentage of subjects Interval 91.0 to 98.0	73 percentage of subjects Interval 64.0 to 80.0

SECONDARY outcome

Timeframe: One Month After Last Vaccination (day 86)

Population: Analysis was done on the primary PP dataset

Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.

Outcome measures

Outcome measures
Measure	2 Through 5 Years (2 Vac) n=136 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=144 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=153 Participants Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=142 Participants Subjects 6-10 years of age received one MenACWY-CRM vaccination
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM MenA(N=135,143,152,142)	68 Titer Interval 54.0 to 86.0	21 Titer Interval 17.0 to 27.0	67 Titer Interval 52.0 to 87.0	36 Titer Interval 28.0 to 47.0
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM MenC(N=131,140,149,142)	146 Titer Interval 115.0 to 186.0	22 Titer Interval 18.0 to 28.0	165 Titer Interval 126.0 to 217.0	67 Titer Interval 51.0 to 89.0
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM MenW(N=128,135,148,138)	191 Titer Interval 150.0 to 243.0	104 Titer Interval 83.0 to 132.0	169 Titer Interval 138.0 to 206.0	95 Titer Interval 78.0 to 117.0
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM MenY(N=128,133,148,142)	70 Titer Interval 55.0 to 90.0	15 Titer Interval 12.0 to 19.0	76 Titer Interval 58.0 to 99.0	26 Titer Interval 20.0 to 34.0

SECONDARY outcome

Timeframe: One year after one vaccination or two vaccinations (day 422).

Population: Analysis was done on the persistence PP dataset

Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.

Outcome measures

Outcome measures
Measure	2 Through 5 Years (2 Vac) n=136 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=144 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=153 Participants Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=142 Participants Subjects 6-10 years of age received one MenACWY-CRM vaccination
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM MenA(N=122,131,142,130)	30 percentages of subjects Interval 22.0 to 39.0	11 percentages of subjects Interval 6.0 to 17.0	30 percentages of subjects Interval 22.0 to 38.0	20 percentages of subjects Interval 14.0 to 28.0
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM MenC(N=123,128,141,130)	61 percentages of subjects Interval 52.0 to 70.0	41 percentages of subjects Interval 32.0 to 50.0	81 percentages of subjects Interval 73.0 to 87.0	55 percentages of subjects Interval 46.0 to 64.0
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM MenW(N=121,127,139,130)	92 percentages of subjects Interval 85.0 to 96.0	91 percentages of subjects Interval 84.0 to 95.0	94 percentages of subjects Interval 89.0 to 97.0	90 percentages of subjects Interval 84.0 to 95.0
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM MenY(N=121,122,140,130)	67 percentages of subjects Interval 58.0 to 75.0	57 percentages of subjects Interval 48.0 to 66.0	75 percentages of subjects Interval 67.0 to 82.0	65 percentages of subjects Interval 57.0 to 74.0

SECONDARY outcome

Timeframe: One year after one vaccination or two vaccinations (day 422).

Population: Analysis was done on the persistence PP dataset

Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.

Outcome measures

Outcome measures
Measure	2 Through 5 Years (2 Vac) n=136 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=144 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=153 Participants Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=142 Participants Subjects 6-10 years of age received one MenACWY-CRM vaccination
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM MenA(N=122,131,142,130)	4.72 Titers Interval 3.91 to 5.71	2.66 Titers Interval 2.22 to 3.19	4.66 Titers Interval 3.75 to 5.81	3.56 Titers Interval 2.84 to 4.46
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM MenC(N=123,128,141,130)	10 Titers Interval 8.34 to 13.0	7.03 Titers Interval 5.63 to 8.76	24 Titers Interval 18.0 to 31.0	15 Titers Interval 12.0 to 20.0
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM MenW(N=121,127,139,130)	49 Titers Interval 39.0 to 62.0	39 Titers Interval 31.0 to 49.0	64 Titers Interval 52.0 to 79.0	47 Titers Interval 38.0 to 59.0
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM MenY(N=121,122,140,130)	14 Titers Interval 11.0 to 17.0	9.88 Titers Interval 7.8 to 13.0	20 Titers Interval 15.0 to 25.0	13 Titers Interval 9.96 to 16.0

SECONDARY outcome

Timeframe: From Days 1-7 after each vaccination

Population: Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.

Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM

Outcome measures

Outcome measures
Measure	2 Through 5 Years (2 Vac) n=176 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=182 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) Subjects 6-10 years of age received one MenACWY-CRM vaccination
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Erythema(N=173,175)	25 subjects	11 subjects	—	—
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Induration(N=173,175)	19 subjects	7 subjects	—	—
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Tenderness (N=174,175)	84 subjects	79 subjects	—	—
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Change in Eating Habits(N=173,175)	26 subjects	30 subjects	—	—
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Sleepiness(N=173,175)	49 subjects	46 subjects	—	—
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Irritability(N=173,175)	51 subjects	50 subjects	—	—
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Body Temperature >=38.0(N=174,175)	9 subjects	12 subjects	—	—

SECONDARY outcome

Timeframe: From Days 1-7 after each vaccination

Population: Analysis was done on the safety dataset

Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM

Outcome measures

Outcome measures
Measure	2 Through 5 Years (2 Vac) n=180 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=175 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) Subjects 6-10 years of age received one MenACWY-CRM vaccination
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Erythema(N=178,166)	23 Subjects	15 Subjects	—	—
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Induration(N=178,166)	24 Subjects	15 Subjects	—	—
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Pain(N=178,166)	106 Subjects	78 Subjects	—	—
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Loss of Appetite(N=177,166)	27 Subjects	14 Subjects	—	—
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Nausea(N=177,165)	29 Subjects	21 Subjects	—	—
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Fatigue(N=177,166)	44 Subjects	25 Subjects	—	—
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Myalgia(N=177,165)	63 Subjects	43 Subjects	—	—
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Arthralgia(N=177,165)	20 Subjects	9 Subjects	—	—
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Headache(N=177,165)	55 Subjects	28 Subjects	—	—
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Body Temperature>=38.0(N=178,166)	11 Subjects	9 Subjects	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 86

Population: Analysis was done on Safety Set Unsolicited AEs

Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM

Outcome measures

Outcome measures
Measure	2 Through 5 Years (2 Vac) n=179 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=179 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=181 Participants Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=174 Participants Subjects 6-10 years of age received one MenACWY-CRM vaccination
Number of Subjects Who Reported Selected AEs After Any Vaccination At least possibly related SAEs	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects Who Reported Selected AEs After Any Vaccination SAEs	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects Who Reported Selected AEs After Any Vaccination Medically attended AEs	50 Subjects	55 Subjects	46 Subjects	46 Subjects
Number of Subjects Who Reported Selected AEs After Any Vaccination At least possibly related medically attended AEs	0 Subjects	3 Subjects	1 Subjects	1 Subjects
Number of Subjects Who Reported Selected AEs After Any Vaccination AEs resulting in premature withdrawal	0 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects Who Reported Selected AEs After Any Vaccination Deaths	0 Subjects	0 Subjects	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: Day 1 to Day 422

Population: Analysis was done on safety set

Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM

Outcome measures

Outcome measures
Measure	2 Through 5 Years (2 Vac) n=179 Participants Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=179 Participants Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=181 Participants Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=174 Participants Subjects 6-10 years of age received one MenACWY-CRM vaccination
Number of Subjects Who Reported Selected AEs After Any Vaccination Medically attended AEs	103 Subjects	101 Subjects	95 Subjects	97 Subjects
Number of Subjects Who Reported Selected AEs After Any Vaccination At least possibly related medically attended AEs	1 Subjects	4 Subjects	1 Subjects	2 Subjects
Number of Subjects Who Reported Selected AEs After Any Vaccination AEs resulting in premature withdrawal	0 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects Who Reported Selected AEs After Any Vaccination SAEs	2 Subjects	1 Subjects	1 Subjects	1 Subjects
Number of Subjects Who Reported Selected AEs After Any Vaccination Deaths	0 Subjects	0 Subjects	0 Subjects	0 Subjects

Adverse Events

2 Through 5 Years (2 Vac)

Serious events: 2 serious events

Other events: 148 other events

Deaths: 0 deaths

2 Through 5 Years (1 Vac)

Serious events: 1 serious events

Other events: 142 other events

Deaths: 0 deaths

6 Through 10 Years (2 Vac)

Serious events: 1 serious events

Other events: 153 other events

Deaths: 0 deaths

6 Through 10 Years (1 Vac)

Serious events: 1 serious events

Other events: 133 other events

Deaths: 0 deaths

Total

Serious events: 5 serious events

Other events: 576 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	2 Through 5 Years (2 Vac) n=179 participants at risk Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=179 participants at risk Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=181 participants at risk Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=174 participants at risk Subjects 6-10 years of age received one MenACWY-CRM vaccination	Total n=713 participants at risk Total Population
Blood and lymphatic system disorders IMMUNE THROMBOCYTOPENIC PURPURA	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.56% 1/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.14% 1/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Infections and infestations OTITIS MEDIA	0.56% 1/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.14% 1/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Metabolism and nutrition disorders DEHYDRATION	0.56% 1/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.14% 1/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Nervous system disorders PETIT MAL EPILEPSY	0.56% 1/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.14% 1/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Psychiatric disorders INTERMITTENT EXPLOSIVE DISORDER	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.57% 1/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.14% 1/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Psychiatric disorders OPPOSITIONAL DEFIANT DISORDER	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.57% 1/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.14% 1/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.55% 1/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.14% 1/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.56% 1/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.14% 1/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.

Other adverse events

Other adverse events
Measure	2 Through 5 Years (2 Vac) n=179 participants at risk Subjects 2-5 years of age received two MenACWY-CRM vaccinations	2 Through 5 Years (1 Vac) n=179 participants at risk Subjects 2-5 years of age received one MenACWY-CRM vaccination	6 Through 10 Years (2 Vac) n=181 participants at risk Subjects 6-10 years of age received two MenACWY-CRM vaccinations	6 Through 10 Years (1 Vac) n=174 participants at risk Subjects 6-10 years of age received one MenACWY-CRM vaccination	Total n=713 participants at risk Total Population
Gastrointestinal disorders ABDOMINAL PAIN UPPER	2.2% 4/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	3.4% 6/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	2.8% 5/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	5.2% 9/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	3.4% 24/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Gastrointestinal disorders DIARRHOEA	4.5% 8/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	5.6% 10/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	2.8% 5/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	2.9% 5/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	3.9% 28/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Gastrointestinal disorders NAUSEA	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	16.0% 29/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	13.2% 23/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	7.3% 52/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Gastrointestinal disorders VOMITING	10.6% 19/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	10.6% 19/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	8.3% 15/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	6.3% 11/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	9.0% 64/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
General disorders FATIGUE	0.56% 1/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.56% 1/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	26.0% 47/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	18.4% 32/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	11.4% 81/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
General disorders INJECTION SITE ERYTHEMA	39.7% 71/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	26.8% 48/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	35.4% 64/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	28.2% 49/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	32.5% 232/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
General disorders INJECTION SITE INDURATION	30.2% 54/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	21.8% 39/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	33.1% 60/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	23.0% 40/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	27.1% 193/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
General disorders INJECTION SITE PAIN	52.0% 93/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	50.8% 91/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	66.3% 120/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	50.6% 88/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	55.0% 392/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
General disorders PYREXIA	16.2% 29/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	19.0% 34/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	14.4% 26/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	14.9% 26/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	16.1% 115/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Infections and infestations CONJUNCTIVITIS	3.9% 7/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	6.1% 11/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.55% 1/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	1.7% 3/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	3.1% 22/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Infections and infestations EAR INFECTION	8.4% 15/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	3.4% 6/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	2.8% 5/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	1.7% 3/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	4.1% 29/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Infections and infestations NASOPHARYNGITIS	1.1% 2/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	6.1% 11/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	2.2% 4/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	2.3% 4/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	2.9% 21/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Infections and infestations OTITIS MEDIA	10.6% 19/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	13.4% 24/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	3.9% 7/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	4.6% 8/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	8.1% 58/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Infections and infestations PHARYNGITIS	8.9% 16/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	8.9% 16/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	9.9% 18/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	3.4% 6/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	7.9% 56/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Infections and infestations PHARYNGITIS STREPTOCOCCAL	6.7% 12/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	10.1% 18/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	9.4% 17/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	8.0% 14/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	8.6% 61/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Infections and infestations SINUSITIS	4.5% 8/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	6.7% 12/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	3.3% 6/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	4.6% 8/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	4.8% 34/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	12.3% 22/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	11.7% 21/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	7.2% 13/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	9.2% 16/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	10.1% 72/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Infections and infestations VIRAL INFECTION	5.0% 9/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	7.3% 13/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	3.9% 7/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	2.3% 4/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	4.6% 33/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Metabolism and nutrition disorders DECREASED APPETITE	0.56% 1/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.56% 1/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	14.9% 27/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	9.2% 16/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	6.3% 45/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	12.2% 22/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	7.5% 13/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	4.9% 35/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	36.5% 66/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	27.6% 48/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	16.0% 114/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Nervous system disorders HEADACHE	3.4% 6/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	4.5% 8/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	34.3% 62/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	21.8% 38/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	16.0% 114/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Nervous system disorders SOMNOLENCE	30.2% 54/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	26.8% 48/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.57% 1/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	14.4% 103/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Psychiatric disorders EATING DISORDER	14.5% 26/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	16.8% 30/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.00% 0/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	7.9% 56/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Psychiatric disorders IRRITABILITY	30.7% 55/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	28.5% 51/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.55% 1/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.57% 1/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	15.1% 108/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Respiratory, thoracic and mediastinal disorders COUGH	12.3% 22/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	9.5% 17/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	6.6% 12/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	8.6% 15/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	9.3% 66/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	1.1% 2/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	5.6% 10/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	1.7% 3/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	0.57% 1/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	2.2% 16/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	7.8% 14/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	5.0% 9/179 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	1.7% 3/181 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	2.9% 5/174 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.	4.3% 31/713 • Throughout study period Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 877-379-3718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60