Trial Outcomes & Findings for Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose (NCT NCT01823536)

Results Overview

The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

465 participants

Primary outcome timeframe

5 years post-vaccination

Results posted on

2014-08-15

Participant Flow

Subjects were recruited from 22 study sites.

All subjects were included in the trial.

Participant milestones

Participant milestones
Measure	MenACWY-CRM_2 (≥7-≤10 Years) Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	Vaccine Naive (≥7-≤10 Years) Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.	MenACWY-CRM_1 (≥11-≤15 Years) Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.	Not Assigned Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate "not assigned" group in the Full Analysis Set and excluded from the Per Protocol Set. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM\_1 (≥7-≤10 Years) group in the extension study.
Overall Study STARTED	73	103	120	66	101	2
Overall Study COMPLETED	71	101	119	64	99	2
Overall Study NOT COMPLETED	2	2	1	2	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MenACWY-CRM_2 (≥7-≤10 Years) Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	Vaccine Naive (≥7-≤10 Years) Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.	MenACWY-CRM_1 (≥11-≤15 Years) Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
Overall Study Lost to Follow-up	1	0	0	1	1
Overall Study Protocol Violation	0	1	0	0	0
Overall Study Withdrawal by Subject	1	1	0	0	0
Overall Study Visit 1 delayed, unable to reschedule	0	0	1	0	0
Overall Study Met exclusion criterion No 6	0	0	0	1	0
Overall Study Subject moved out of the state	0	0	0	0	1

Baseline Characteristics

Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenACWY-CRM_2 (≥7-≤10 Years) n=73 Participants Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) n=103 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	Vaccine Naive (≥7-≤10 Years) n=120 Participants Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.	MenACWY-CRM_1 (≥11-≤15 Years) n=66 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) n=101 Participants Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.	Not Assigned n=2 Participants Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate "not assigned" group in the FAS and excluded from the PPS. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM\_1 (≥7-≤10 Years) group in the extension study.	Total n=465 Participants Total of all reporting groups
Age, Continuous	8.3 years STANDARD_DEVIATION 1.1 • n=5 Participants	8.1 years STANDARD_DEVIATION 1.2 • n=7 Participants	8.5 years STANDARD_DEVIATION 1.1 • n=5 Participants	13.0 years STANDARD_DEVIATION 1.6 • n=4 Participants	11.8 years STANDARD_DEVIATION 1.0 • n=21 Participants	8.0 years STANDARD_DEVIATION 1.4 • n=8 Participants	9.7 years STANDARD_DEVIATION 2.3 • n=8 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	49 Participants n=7 Participants	63 Participants n=5 Participants	28 Participants n=4 Participants	46 Participants n=21 Participants	1 Participants n=8 Participants	222 Participants n=8 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	54 Participants n=7 Participants	57 Participants n=5 Participants	38 Participants n=4 Participants	55 Participants n=21 Participants	1 Participants n=8 Participants	243 Participants n=8 Participants

PRIMARY outcome

Timeframe: 5 years post-vaccination

Population: The analysis was done on per-protocol population i.e all subjects who provided immunogenicity data; had no major protocol deviations and who were not excluded due to other reasons defined prior to analysis.

The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA).

Outcome measures

Outcome measures
Measure	MenACWY-CRM_2 (≥7-≤10 Years) n=70 Participants Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) n=96 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=64 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine Serogroup C (N= 69, 96, 64)	48 Percentages of subjects Interval 36.0 to 60.0	32 Percentages of subjects Interval 23.0 to 43.0	56 Percentages of subjects Interval 43.0 to 69.0	—	—
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine Serogroup A (N=68, 96, 64)	7 Percentages of subjects Interval 2.0 to 16.0	14 Percentages of subjects Interval 7.0 to 22.0	22 Percentages of subjects Interval 13.0 to 34.0	—	—
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine Serogroup W (N= 69, 96, 64)	83 Percentages of subjects Interval 72.0 to 91.0	74 Percentages of subjects Interval 64.0 to 82.0	80 Percentages of subjects Interval 68.0 to 89.0	—	—
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine Serogroup Y	50 Percentages of subjects Interval 38.0 to 62.0	48 Percentages of subjects Interval 38.0 to 58.0	53 Percentages of subjects Interval 40.0 to 66.0	—	—

SECONDARY outcome

Timeframe: 5 years post-vaccination

Population: The analysis was done on per-protocol population.

The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.

Outcome measures

Outcome measures
Measure	MenACWY-CRM_2 (≥7-≤10 Years) n=70 Participants Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) n=96 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=64 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. Serogroup A (N=68, 96, 64)	2.41 Titers Interval 2.09 to 2.78	2.95 Titers Interval 2.42 to 3.61	3.73 Titers Interval 2.74 to 5.06	—	—
Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. Serogroup C (N= 69, 96, 64)	7.55 Titers Interval 5.44 to 10.0	6.5 Titers Interval 4.75 to 8.9	12 Titers Interval 7.72 to 19.0	—	—
Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. Serogroup W (N= 69, 96, 64)	23 Titers Interval 17.0 to 31.0	19 Titers Interval 14.0 to 25.0	26 Titers Interval 18.0 to 38.0	—	—
Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. Serogroup Y	8.57 Titers Interval 6.08 to 12.0	8.13 Titers Interval 6.11 to 11.0	10 Titers Interval 6.51 to 16.0	—	—

SECONDARY outcome

Timeframe: 5 years post-vaccination; baseline for naive

Population: The analysis was done on per-protocol population.

The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects.

Outcome measures

Outcome measures
Measure	MenACWY-CRM_2 (≥7-≤10 Years) n=70 Participants Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) n=96 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=118 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=64 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) n=100 Participants Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects Serogroup A (N= 68, 96, 118, 64, 100)	7 Percentages of subjects Interval 2.0 to 16.0	14 Percentages of subjects Interval 7.0 to 22.0	0 Percentages of subjects Interval 0.0 to 3.0	22 Percentages of subjects Interval 13.0 to 34.0	5 Percentages of subjects Interval 2.0 to 11.0
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects Serogroup C (N= 69, 96, 118, 64, 99)	48 Percentages of subjects Interval 36.0 to 60.0	32 Percentages of subjects Interval 23.0 to 43.0	21 Percentages of subjects Interval 14.0 to 30.0	56 Percentages of subjects Interval 43.0 to 69.0	21 Percentages of subjects Interval 14.0 to 31.0
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects Serogroup W (N= 69, 96, 118, 64, 100)	83 Percentages of subjects Interval 72.0 to 91.0	74 Percentages of subjects Interval 64.0 to 82.0	52 Percentages of subjects Interval 42.0 to 61.0	80 Percentages of subjects Interval 68.0 to 89.0	54 Percentages of subjects Interval 44.0 to 64.0
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects Serogroup Y	50 Percentages of subjects Interval 38.0 to 62.0	48 Percentages of subjects Interval 38.0 to 58.0	23 Percentages of subjects Interval 16.0 to 32.0	53 Percentages of subjects Interval 40.0 to 66.0	37 Percentages of subjects Interval 28.0 to 47.0

SECONDARY outcome

Timeframe: Day 28 post-vaccination

Population: The analysis was done on per-protocol population.

The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8.

Outcome measures

Outcome measures
Measure	MenACWY-CRM_2 (≥7-≤10 Years) n=65 Participants Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) n=95 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=110 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=60 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) n=85 Participants Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Serogroup A (N= 63, 95, 109, 60, 85)	98 Percentages of subjects Interval 91.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	75 Percentages of subjects Interval 66.0 to 83.0	100 Percentages of subjects Interval 94.0 to 100.0	80 Percentages of subjects Interval 70.0 to 88.0
Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Serogroup C (N= 65, 94, 109, 60, 85)	100 Percentages of subjects Interval 94.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	82 Percentages of subjects Interval 73.0 to 88.0	100 Percentages of subjects Interval 94.0 to 100.0	86 Percentages of subjects Interval 77.0 to 92.0
Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Serogroup W (N= 63, 95, 110, 60, 85)	100 Percentages of subjects Interval 94.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	94 Percentages of subjects Interval 87.0 to 97.0	100 Percentages of subjects Interval 94.0 to 100.0	92 Percentages of subjects Interval 84.0 to 97.0
Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Serogroup Y (N= 65, 94, 110, 59, 85)	100 Percentages of subjects Interval 94.0 to 100.0	100 Percentages of subjects Interval 96.0 to 100.0	85 Percentages of subjects Interval 77.0 to 91.0	100 Percentages of subjects Interval 94.0 to 100.0	82 Percentages of subjects Interval 73.0 to 90.0

SECONDARY outcome

Timeframe: Day 28 post-vaccination

Population: The analysis was done on per-protocol population.

The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs.

Outcome measures

Outcome measures
Measure	MenACWY-CRM_2 (≥7-≤10 Years) n=65 Participants Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) n=95 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=110 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=60 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) n=85 Participants Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Serogroup A (N= 63, 95, 109, 60, 85)	321 Titers Interval 241.0 to 428.0	361 Titers Interval 299.0 to 436.0	28 Titers Interval 20.0 to 39.0	350 Titers Interval 265.0 to 463.0	31 Titers Interval 22.0 to 45.0
Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Serogroup C (N= 65, 94, 109, 60, 85)	760 Titers Interval 545.0 to 1059.0	498 Titers Interval 406.0 to 610.0	48 Titers Interval 33.0 to 70.0	712 Titers Interval 490.0 to 1036.0	102 Titers Interval 63.0 to 166.0
Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Serogroup W (N= 63, 95, 110, 60, 85)	1571 Titers Interval 1247.0 to 1980.0	1534 Titers Interval 1255.0 to 1873.0	55 Titers Interval 42.0 to 72.0	1556 Titers Interval 1083.0 to 2237.0	69 Titers Interval 48.0 to 99.0
Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Serogroup Y (N= 65, 94, 110, 59, 85)	1286 Titers Interval 992.0 to 1668.0	1693 Titers Interval 1360.0 to 2107.0	48 Titers Interval 34.0 to 66.0	1442 Titers Interval 1050.0 to 1979.0	45 Titers Interval 30.0 to 69.0

SECONDARY outcome

Timeframe: Day 1 to day 7 post-vaccination

Population: The analysis was done on solicited safety set, ie, all subjects in the exposed set who provided post vaccination solicited reactogenicity data.

The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to, 1. Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine 2. Vaccine-naive subjects.

Outcome measures

Outcome measures
Measure	MenACWY-CRM_2 (≥7-≤10 Years) n=69 Participants Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) n=100 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=119 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=64 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) n=98 Participants Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Injection site erythema (N= 68, 99, 117, 64, 98)	10 Number of subjects	13 Number of subjects	10 Number of subjects	10 Number of subjects	6 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Injection site induration (N= 68, 99, 119, 64, 98)	12 Number of subjects	12 Number of subjects	7 Number of subjects	7 Number of subjects	8 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Chills (N= 68, 99, 117, 64, 98)	5 Number of subjects	3 Number of subjects	6 Number of subjects	1 Number of subjects	2 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Malaise (N= 69, 99, 117, 64, 98)	15 Number of subjects	14 Number of subjects	13 Number of subjects	11 Number of subjects	19 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Myalgia (N= 69, 99, 117, 64, 98)	9 Number of subjects	8 Number of subjects	8 Number of subjects	4 Number of subjects	8 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Arthralgia (N= 69, 99, 117, 64, 98)	8 Number of subjects	4 Number of subjects	5 Number of subjects	4 Number of subjects	8 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Headache (N= 69, 99, 117, 64, 97)	13 Number of subjects	9 Number of subjects	22 Number of subjects	12 Number of subjects	21 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Nausea (N= 68, 99, 117, 64, 97)	10 Number of subjects	11 Number of subjects	12 Number of subjects	7 Number of subjects	8 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Fever (≥38°C; N= 66, 99, 115, 64, 96)	1 Number of subjects	0 Number of subjects	3 Number of subjects	1 Number of subjects	0 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Prophyl. use analg/antip (N= 68, 99, 118, 63, 97)	0 Number of subjects	1 Number of subjects	2 Number of subjects	1 Number of subjects	1 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Thera. use anal/antipyret (N= 69, 99, 118, 64, 97)	14 Number of subjects	12 Number of subjects	11 Number of subjects	11 Number of subjects	6 Number of subjects
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Injection site pain (N= 68, 99, 117, 64, 98)	39 Number of subjects	52 Number of subjects	42 Number of subjects	31 Number of subjects	47 Number of subjects

SECONDARY outcome

Timeframe: Day 1 to day 28

Population: The analysis was done on unsolicited safety set, ie, all exposed subjects who provided unsolicited adverse events (AE) data.

The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal.

Outcome measures

Outcome measures
Measure	MenACWY-CRM_2 (≥7-≤10 Years) n=73 Participants Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) n=102 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=120 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	MenACWY-CRM_1 (≥11-≤15 Years) n=65 Participants Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) n=100 Participants Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Any adverse event (AE)	18 Number of subjects	23 Number of subjects	19 Number of subjects	18 Number of subjects	11 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Possibly/Probably related unsolicited AE	4 Number of subjects	3 Number of subjects	4 Number of subjects	7 Number of subjects	5 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Any SAE	0 Number of subjects	0 Number of subjects	1 Number of subjects	0 Number of subjects	1 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Possibly/Probably related SAE	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. AE leading to withdrawal	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. Death	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects

Adverse Events

MenACWY-CRM_2 (≥7-≤10 Years)

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

MenACWY-CRM_1 (≥7-≤10 Years)

Serious events: 0 serious events

Other events: 70 other events

Deaths: 0 deaths

Vaccine Naive (≥7-≤10 Years)

Serious events: 1 serious events

Other events: 77 other events

Deaths: 0 deaths

MenACWY-CRM_1 (≥11-≤15 Years)

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Vaccine Naive (≥11-≤15 Years)

Serious events: 1 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MenACWY-CRM_2 (≥7-≤10 Years) n=73 participants at risk Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) n=102 participants at risk Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	Vaccine Naive (≥7-≤10 Years) n=120 participants at risk Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.	MenACWY-CRM_1 (≥11-≤15 Years) n=65 participants at risk Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) n=100 participants at risk Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
Infections and infestations Gastroenteritis	0.00% 0/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	0.00% 0/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	0.83% 1/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	0.00% 0/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	0.00% 0/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
Infections and infestations Viral infection	0.00% 0/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	0.00% 0/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	0.00% 0/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	0.00% 0/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	1.0% 1/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.

Other adverse events

Other adverse events
Measure	MenACWY-CRM_2 (≥7-≤10 Years) n=73 participants at risk Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	MenACWY-CRM_1 (≥7-≤10 Years) n=102 participants at risk Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.	Vaccine Naive (≥7-≤10 Years) n=120 participants at risk Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.	MenACWY-CRM_1 (≥11-≤15 Years) n=65 participants at risk Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.	Vaccine Naive (≥11-≤15 Years) n=100 participants at risk Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
Gastrointestinal disorders Nausea	16.4% 12/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	11.8% 12/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	11.7% 14/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	12.3% 8/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	9.0% 9/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
General disorders Chills	6.8% 5/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	2.9% 3/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	5.0% 6/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	3.1% 2/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	2.0% 2/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
General disorders Injection site erythema	34.2% 25/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	33.3% 34/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	23.3% 28/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	26.2% 17/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	21.0% 21/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
General disorders Injection site induration	28.8% 21/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	25.5% 26/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	21.7% 26/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	26.2% 17/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	17.0% 17/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
General disorders Injection site pain	57.5% 42/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	55.9% 57/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	42.5% 51/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	52.3% 34/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	52.0% 52/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
General disorders Malaise	20.5% 15/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	13.7% 14/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	10.8% 13/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	18.5% 12/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	19.0% 19/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
Musculoskeletal and connective tissue disorders Arthralgia	11.0% 8/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	4.9% 5/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	4.2% 5/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	6.2% 4/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	9.0% 9/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
Musculoskeletal and connective tissue disorders Myalgia	13.7% 10/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	12.7% 13/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	8.3% 10/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	6.2% 4/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	9.0% 9/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
Nervous system disorders Headache	19.2% 14/73 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	10.8% 11/102 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	19.2% 23/120 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	23.1% 15/65 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.	23.0% 23/100 • All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28). All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER