Trial Outcomes & Findings for Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India (NCT NCT01547715)

NCT ID: NCT01547715

Last Updated: 2018-10-09

Results Overview

The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as: * For subjects with a pre-vaccination hSBA titer \<1:4, a postvaccination hSBA titer≥1:8 * For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 180 participants
• Primary outcome timeframe: Day 29 (1 month post vaccination)
• Results posted on: 2018-10-09

Participant Flow

Subjects were enrolled from 3 study sites.

All the enrolled subjects were included in the trial.

Participant milestones

Measure	2 - 10 Years Subjects between 2 and 10 years of age received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years Subjects between 11 and 18 years of age received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1.
Overall Study STARTED	60	60	60
Overall Study COMPLETED	60	60	60
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India

Baseline characteristics by cohort

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age received one injection of MenACWY -CRM vaccine on day 1	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age received one injection of MenACWY -CRM vaccine on day 1	19 - 75 Years n=60 Participants Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1.	Total n=180 Participants Total of all reporting groups
Age, Continuous	5.77 YEARS STANDARD_DEVIATION 2.5 • n=5 Participants	14.03 YEARS STANDARD_DEVIATION 1.931 • n=7 Participants	32.67 YEARS STANDARD_DEVIATION 12.297 • n=5 Participants	17.49 YEARS STANDARD_DEVIATION 13.432 • n=4 Participants
Sex: Female, Male FEMALE	33 Participants n=5 Participants	33 Participants n=7 Participants	21 Participants n=5 Participants	87 Participants n=4 Participants
Sex: Female, Male MALE	27 Participants n=5 Participants	27 Participants n=7 Participants	39 Participants n=5 Participants	93 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 29 (1 month post vaccination)

Population: Analysis was done on the Full Analysis Set (FAS), ie, all subjects in the exposed population who provided at least one evaluable serum sample whose assay result is available for at least one serogroup.

The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as:

• For subjects with a pre-vaccination hSBA titer <1:4, a postvaccination hSBA titer≥1:8
• For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=58 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=177 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.	75 Percentages of subjects Interval 62.0 to 85.0	76 Percentages of subjects Interval 63.0 to 86.0	66 Percentages of subjects Interval 52.0 to 78.0	72 Percentages of subjects Interval 65.0 to 79.0

PRIMARY outcome

Timeframe: Day 29 (1 month post vaccination)

Population: Analysis was done on the FAS.

The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.

Outcome measures

Measure	2 - 10 Years n=58 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=58 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=175 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C	84 Percentages of subjects Interval 73.0 to 93.0	90 Percentages of subjects Interval 79.0 to 96.0	90 Percentages of subjects Interval 79.0 to 96.0	88 Percentages of subjects Interval 82.0 to 92.0

PRIMARY outcome

Timeframe: Day 29 (1 month post vaccination)

Population: Analysis was done on the FAS.

The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=57 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=176 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.	58 Percentages of subjects Interval 45.0 to 71.0	51 Percentages of subjects Interval 37.0 to 64.0	54 Percentages of subjects Interval 41.0 to 68.0	55 Percentages of subjects Interval 47.0 to 62.0

PRIMARY outcome

Timeframe: Day 29 (1 month post vaccination)

Population: Analysis was done on the FAS.

The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.

Outcome measures

Measure	2 - 10 Years n=58 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=57 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=174 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.	69 Percentages of subjects Interval 55.0 to 80.0	69 Percentages of subjects Interval 56.0 to 81.0	75 Percentages of subjects Interval 62.0 to 86.0	71 Percentages of subjects Interval 64.0 to 78.0

SECONDARY outcome

Timeframe: Day 1

Population: Analysis was done on the FAS

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=60 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=179 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.	0 Percentage of subjects Interval 0.0 to 6.0	2 Percentage of subjects Interval 0.0 to 9.0	2 Percentage of subjects Interval 0.0 to 9.0	1 Percentage of subjects Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Day 29 (ie, 1 month post vaccination)

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 29.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=58 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=178 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.	75 Percentages of subjects Interval 62.0 to 85.0	77 Percentages of subjects Interval 64.0 to 87.0	66 Percentages of subjects Interval 52.0 to 78.0	72 Percentages of subjects Interval 65.0 to 79.0

SECONDARY outcome

Timeframe: Day 1

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1.

Outcome measures

Measure	2 - 10 Years n=58 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=60 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=177 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.	14 Percentages of subjects Interval 6.0 to 25.0	24 Percentages of subjects Interval 14.0 to 37.0	25 Percentages of subjects Interval 15.0 to 38.0	21 Percentages of subjects Interval 15.0 to 28.0

SECONDARY outcome

Timeframe: Day 29 (ie, 1 month post vaccination)

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 29.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=58 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=178 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.	92 Percentages of subjects Interval 82.0 to 97.0	97 Percentages of subjects Interval 88.0 to 100.0	97 Percentages of subjects Interval 88.0 to 100.0	95 Percentages of subjects Interval 91.0 to 98.0

SECONDARY outcome

Timeframe: Day 1

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=59 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=178 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.	52 Percentages of subjects Interval 38.0 to 65.0	63 Percentages of subjects Interval 49.0 to 75.0	59 Percentages of subjects Interval 46.0 to 72.0	58 Percentages of subjects Interval 50.0 to 65.0

SECONDARY outcome

Timeframe: Day 29

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=58 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=178 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.	95 Percentage of subjects Interval 86.0 to 99.0	95 Percentage of subjects Interval 86.0 to 99.0	93 Percentage of subjects Interval 83.0 to 98.0	94 Percentage of subjects Interval 90.0 to 97.0

SECONDARY outcome

Timeframe: Day 1

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 1.

Outcome measures

Measure	2 - 10 Years n=59 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=59 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=177 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1	22 Percentages of subjects Interval 12.0 to 35.0	53 Percentages of subjects Interval 39.0 to 66.0	53 Percentages of subjects Interval 39.0 to 66.0	42 Percentages of subjects Interval 35.0 to 50.0

SECONDARY outcome

Timeframe: Day 29 (ie, 1 month post vaccination)

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 29.

Outcome measures

Measure	2 - 10 Years n=59 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=58 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=177 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29	83 Percentages of subjects Interval 71.0 to 92.0	95 Percentages of subjects Interval 86.0 to 99.0	93 Percentages of subjects Interval 83.0 to 98.0	90 Percentages of subjects Interval 85.0 to 94.0

SECONDARY outcome

Timeframe: Day 1

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=60 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=179 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1	2.08 Titer Interval 1.97 to 2.2	2.05 Titer Interval 1.95 to 2.16	2.07 Titer Interval 1.93 to 2.21	2.07 Titer Interval 2.0 to 2.14

SECONDARY outcome

Timeframe: Day 29 ( ie, 1 month post vaccination)

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 29.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=58 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=178 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29	30 Titer Interval 19.0 to 47.0	50 Titer Interval 30.0 to 84.0	29 Titer Interval 16.0 to 51.0	35 Titer Interval 26.0 to 47.0

SECONDARY outcome

Timeframe: Day 1

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1.

Outcome measures

Measure	2 - 10 Years n=58 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=60 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=177 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1	2.88 Titer Interval 2.26 to 3.65	4.01 Titer Interval 3.0 to 5.35	4.14 Titer Interval 3.12 to 5.49	3.63 Titer Interval 3.11 to 4.25

SECONDARY outcome

Timeframe: Day 29 (ie, 1 month post vaccination)

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 29.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=58 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=178 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29	67 Titer Interval 44.0 to 101.0	191 Titer Interval 117.0 to 310.0	287 Titer Interval 191.0 to 431.0	153 Titer Interval 117.0 to 199.0

SECONDARY outcome

Timeframe: Day 1

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=59 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=178 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1	9.27 Titer Interval 6.33 to 14.0	14 Titer Interval 9.13 to 20.0	12 Titer Interval 7.7 to 17.0	11 Titer Interval 9.05 to 14.0

SECONDARY outcome

Timeframe: Day 29 (ie, 1 month post vaccination)

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 29.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=58 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=178 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29	60 Titer Interval 44.0 to 81.0	75 Titer Interval 54.0 to 105.0	116 Titer Interval 71.0 to 187.0	80 Titer Interval 64.0 to 100.0

SECONDARY outcome

Timeframe: Day 1

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 1.

Outcome measures

Measure	2 - 10 Years n=59 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=59 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=59 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=177 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1	3.59 Titer Interval 2.75 to 4.7	7.87 Titer Interval 5.48 to 11.0	8.69 Titer Interval 5.98 to 13.0	6.26 Titer Interval 5.13 to 7.65

SECONDARY outcome

Timeframe: Day 29 (ie, 1 month post vaccination)

Population: Analysis was done on the FAS.

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 29.

Outcome measures

Measure	2 - 10 Years n=59 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=58 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=177 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29	45 Titer Interval 29.0 to 69.0	105 Titer Interval 72.0 to 155.0	173 Titer Interval 97.0 to 309.0	93 Titer Interval 70.0 to 123.0

SECONDARY outcome

Timeframe: From day 1 to Day 7 post vaccination

Population: The analysis was performed on the safety analysis set, ie, all subjects in the exposed population who provided any post-baseline safety data.

The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=60 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=180 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination INJECTION SITE REACTIONS	5 Participants	17 Participants	5 Participants	27 Participants
Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination SYSTEMIC REACTIONS	3 Participants	7 Participants	9 Participants	19 Participants

SECONDARY outcome

Timeframe: From day 1 to Day 7 post vaccination

Population: The analysis was performed on the safety analysis set.

The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=60 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=180 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination INDURATION (mm)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination ANALGESIC ANTIPYRETIC	2 Participants	5 Participants	2 Participants	9 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination Body Temperature >=40C	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination ERYTHEMA (mm)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination PAIN	4 Participants	17 Participants	5 Participants	26 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination TENDERNESS	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination ARTHRALGIA	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination BODY TEMPERATURE >=38C	1 Participants	1 Participants	1 Participants	3 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination CHANGE IN EATING HABITS	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination CHILLS	0 Participants	4 Participants	2 Participants	6 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination DIARRHEA	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination HEADACHE	2 Participants	5 Participants	7 Participants	14 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination IRRITABILITY	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination MALAISE	2 Participants	2 Participants	2 Participants	6 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination MYALGIA	1 Participants	0 Participants	2 Participants	3 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination NAUSEA	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination RASH	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination SLEEPINESS	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination VOMITING	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 through day 29

Population: The analysis was performed on the safety analysis dataset.

The safety of one dose of MenACWY -CRM was assessed in terms of the number of subjects reporting unsolicited adverse events. All AEs were recorded from day 1 to day 7; SAE, medically attended AEs and AEs Leading to premature withdrawal were recorded throughout the entire study period.

Outcome measures

Measure	2 - 10 Years n=60 Participants Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 Participants Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=60 Participants Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Overall (≥2 Years) n=180 Participants Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Number of Subjects With Unsolicited Adverse Events Any Unsolicited AE	9 participants	6 participants	4 participants	19 participants
Number of Subjects With Unsolicited Adverse Events Any SAE	0 participants	0 participants	1 participants	0 participants
Number of Subjects With Unsolicited Adverse Events Medically Attended AEs	8 participants	5 participants	4 participants	17 participants
Number of Subjects With Unsolicited Adverse Events AEs Leading to premature withdrawal	0 participants	0 participants	0 participants	0 participants

Adverse Events

2 - 10 Years

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

11 - 18 Years

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

19 - 75 Years

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Overall (≥2 Years)

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	2 - 10 Years n=60 participants at risk Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 participants at risk Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=60 participants at risk Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1	Overall (≥2 Years) n=180 participants at risk Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
General disorders PYREXIA	0.00% 0/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	0.00% 0/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	1.7% 1/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	0.56% 1/180 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.

Other adverse events

Measure	2 - 10 Years n=60 participants at risk Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	11 - 18 Years n=60 participants at risk Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	19 - 75 Years n=60 participants at risk Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1	Overall (≥2 Years) n=180 participants at risk Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
General disorders CHILLS	0.00% 0/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	6.7% 4/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	3.3% 2/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	3.3% 6/180 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.
General disorders INJECTION SITE PAIN	8.3% 5/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	28.3% 17/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	8.3% 5/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	15.0% 27/180 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	6.7% 4/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	1.7% 1/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	0.00% 0/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	2.8% 5/180 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.
Nervous system disorders HEADACHE	3.3% 2/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	8.3% 5/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	11.7% 7/60 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.	7.8% 14/180 • Day 1 to Day 29 post vaccination. Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics SRL

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60