Trial Outcomes & Findings for Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine (NCT NCT00856297)

Last Updated: 2017-06-14

Results Overview

Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

389 participants

Primary outcome timeframe

21 months, 3 years and 5 years postvaccination

Results posted on

2017-06-14

Participant Flow

Subjects were recruited from 19 sites in US.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	MenACWY-CRM Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	Naive Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Overall Study STARTED	131	76	107	44	31
Overall Study COMPLETED	129	76	107	44	31
Overall Study NOT COMPLETED	2	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MenACWY-CRM Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	Naive Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Overall Study Unable to classify	2	0	0	0	0

Baseline Characteristics

Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenACWY-CRM n=131 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=76 Participants Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	Naive n=107 Participants Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.	MenACWY-CRM/MenACWY-CRM n=44 Participants Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM n=31 Participants Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Total n=389 Participants Total of all reporting groups
Age, Continuous	19.4 years STANDARD_DEVIATION 2.4 • n=5 Participants	18.8 years STANDARD_DEVIATION 2.4 • n=7 Participants	19.3 years STANDARD_DEVIATION 2.4 • n=5 Participants	19.0 years STANDARD_DEVIATION 1.9 • n=4 Participants	19.7 years STANDARD_DEVIATION 2.3 • n=21 Participants	19.2 years STANDARD_DEVIATION 2.3 • n=8 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	29 Participants n=7 Participants	68 Participants n=5 Participants	21 Participants n=4 Participants	13 Participants n=21 Participants	196 Participants n=8 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	47 Participants n=7 Participants	39 Participants n=5 Participants	23 Participants n=4 Participants	18 Participants n=21 Participants	193 Participants n=8 Participants

PRIMARY outcome

Timeframe: 21 months, 3 years and 5 years postvaccination

Population: Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=102 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=60 Participants Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenA - 21 months	44 percentages of subjects Interval 34.0 to 54.0	27 percentages of subjects Interval 16.0 to 40.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 3 Years	37 percentages of subjects Interval 28.0 to 47.0	18 percentages of subjects Interval 10.0 to 30.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 5 Years	34 percentages of subjects Interval 25.0 to 44.0	37 percentages of subjects Interval 25.0 to 50.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Men C - 21 Months (N=102, 59)	61 percentages of subjects Interval 51.0 to 70.0	63 percentages of subjects Interval 49.0 to 75.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 3 Years (N=102, 59)	68 percentages of subjects Interval 58.0 to 77.0	68 percentages of subjects Interval 54.0 to 79.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 5 Years (N=102, 59)	64 percentages of subjects Interval 54.0 to 73.0	63 percentages of subjects Interval 49.0 to 75.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenW- 21 Months (N=101, 57)	86 percentages of subjects Interval 78.0 to 92.0	60 percentages of subjects Interval 46.0 to 72.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 3 Years (N=101, 57)	85 percentages of subjects Interval 77.0 to 91.0	65 percentages of subjects Interval 51.0 to 77.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 5 Years (N=101, 57)	85 percentages of subjects Interval 77.0 to 91.0	70 percentages of subjects Interval 57.0 to 82.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenY- 21 Months	71 percentages of subjects Interval 61.0 to 79.0	53 percentages of subjects Interval 40.0 to 66.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Three Years	69 percentages of subjects Interval 59.0 to 77.0	55 percentages of subjects Interval 42.0 to 68.0	—	—
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Five Years	67 percentages of subjects Interval 57.0 to 76.0	55 percentages of subjects Interval 42.0 to 68.0	—	—

SECONDARY outcome

Timeframe: 21 months, 3 years and 5 years postvaccination

Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=102 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=60 Participants Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenA - 21 Months	44 percentages of subjects Interval 34.0 to 54.0	32 percentages of subjects Interval 20.0 to 45.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 3 Years	38 percentages of subjects Interval 29.0 to 48.0	22 percentages of subjects Interval 12.0 to 34.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 5 Years	37 percentages of subjects Interval 28.0 to 47.0	37 percentages of subjects Interval 25.0 to 50.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenC - 21 Months (N=102, 59)	73 percentages of subjects Interval 63.0 to 81.0	71 percentages of subjects Interval 58.0 to 82.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 3 Years (N= 102, 59)	79 percentages of subjects Interval 70.0 to 87.0	78 percentages of subjects Interval 65.0 to 88.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 5 Years (N=102, 59)	72 percentages of subjects Interval 62.0 to 80.0	71 percentages of subjects Interval 58.0 to 82.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenW - 21 Months (N=101, 57)	89 percentages of subjects Interval 81.0 to 94.0	61 percentages of subjects Interval 48.0 to 74.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 3 Years (N=101, 57)	88 percentages of subjects Interval 80.0 to 94.0	67 percentages of subjects Interval 53.0 to 79.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 5 Years (N=101, 57)	85 percentages of subjects Interval 77.0 to 91.0	70 percentages of subjects Interval 57.0 to 82.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenY - 21 Months	78 percentages of subjects Interval 69.0 to 86.0	63 percentages of subjects Interval 50.0 to 75.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Three Years	76 percentages of subjects Interval 67.0 to 84.0	63 percentages of subjects Interval 50.0 to 75.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Five Years	74 percentages of subjects Interval 64.0 to 82.0	63 percentages of subjects Interval 50.0 to 75.0	—	—

SECONDARY outcome

Timeframe: 21 months, 3 years and 5 years postvaccination

Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=102 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=60 Participants Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenA- 21 Months	6.46 titers Interval 4.7 to 8.88	4.12 titers Interval 2.84 to 5.99	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 3 Years	5.51 titers Interval 3.89 to 7.81	3.69 titers Interval 2.45 to 5.55	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 5 Years	4.36 titers Interval 3.09 to 6.14	4.92 titers Interval 3.29 to 7.37	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenC - 21 Months (N=102, 59)	11 titers Interval 8.01 to 14.0	7.62 titers Interval 5.38 to 11.0	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 3 Years (N=102, 59)	16 titers Interval 11.0 to 26.0	17 titers Interval 10.0 to 29.0	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 5 Years (N=102, 59)	14 titers Interval 8.74 to 24.0	20 titers Interval 11.0 to 35.0	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenW- 21 Months (N=101, 57)	18 titers Interval 14.0 to 25.0	9.3 titers Interval 6.59 to 13.0	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 3 Years (N=101, 57)	31 titers Interval 21.0 to 46.0	17 titers Interval 11.0 to 28.0	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine 5 Years (N=101, 57)	32 titers Interval 21.0 to 47.0	19 titers Interval 12.0 to 31.0	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine MenY- 21 Months	14 titers Interval 10.0 to 19.0	6.83 titers Interval 4.76 to 9.79	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Three Years	14 titers Interval 9.68 to 20.0	7.17 titers Interval 4.68 to 11.0	—	—
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Five Years	13 titers Interval 8.71 to 20.0	8.11 titers Interval 4.98 to 13.0	—	—

SECONDARY outcome

Timeframe: day 1

Population: Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.

Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=106 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 Men A - hSBA ≥ 1:4	11 percentages of subjects Interval 6.0 to 19.0	—	—	—
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 Men A-hSBA ≥ 1:8	8 percentages of subjects Interval 3.0 to 14.0	—	—	—
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 MenC- hSBA ≥ 1:4 (N=105)	51 percentages of subjects Interval 41.0 to 61.0	—	—	—
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 MenC-hSBA ≥ 1:8 (N=105)	38 percentages of subjects Interval 29.0 to 48.0	—	—	—
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 MenW - hSBA ≥ 1:4 (N=105)	66 percentages of subjects Interval 56.0 to 75.0	—	—	—
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 MenW-hSBA ≥ 1:8 (N=105)	66 percentages of subjects Interval 56.0 to 75.0	—	—	—
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 MenY - hSBA ≥ 1:4 (N=105)	45 percentages of subjects Interval 35.0 to 55.0	—	—	—
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 MenY-hSBA ≥ 1:8 (N=105)	39 percentages of subjects Interval 30.0 to 49.0	—	—	—

SECONDARY outcome

Timeframe: day 1

Population: Analysis was done on PP persistence population (Naive subjects) - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.

Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=106 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination MenA	2.34 titers Interval 1.73 to 3.16	—	—	—
hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination MenC (N=105)	4.33 titers Interval 2.72 to 6.88	—	—	—
hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination MenW (N=105)	18 titers Interval 12.0 to 27.0	—	—	—
hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination MenY (N=105)	5.4 titers Interval 3.61 to 8.1	—	—	—

SECONDARY outcome

Timeframe: 1 month post booster vaccination

Population: Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.

Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=42 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=30 Participants Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine MenA hSBA ≥ 1:4	100 percentages of subjects Interval 92.0 to 100.0	100 percentages of subjects Interval 88.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine MenC≥ 1:4	100 percentages of subjects Interval 92.0 to 100.0	100 percentages of subjects Interval 88.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine MenW ≥ 1:4 (N=41, 29)	100 percentages of subjects Interval 91.0 to 100.0	100 percentages of subjects Interval 88.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine MenY≥ 1:8	100 percentages of subjects Interval 92.0 to 100.0	100 percentages of subjects Interval 88.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine MenA hSBA ≥ 1:8	100 percentages of subjects Interval 92.0 to 100.0	100 percentages of subjects Interval 88.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine MenC≥ 1:8	100 percentages of subjects Interval 92.0 to 100.0	100 percentages of subjects Interval 88.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine MenW ≥ 1:8 (N=41, 29)	100 percentages of subjects Interval 91.0 to 100.0	100 percentages of subjects Interval 88.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine MenY≥ 1:4	95 percentages of subjects Interval 84.0 to 99.0	93 percentages of subjects Interval 78.0 to 99.0	—	—

SECONDARY outcome

Timeframe: 2 years postvaccination

Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=44 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=31 Participants Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenA hSBA ≥ 1:4	77 percentages of subjects Interval 62.0 to 89.0	87 percentages of subjects Interval 70.0 to 96.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenA hSBA ≥ 1:8	77 percentages of subjects Interval 62.0 to 89.0	77 percentages of subjects Interval 59.0 to 90.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenC hSBA ≥ 1:4	95 percentages of subjects Interval 85.0 to 99.0	97 percentages of subjects Interval 83.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenC hSBA ≥ 1:8	95 percentages of subjects Interval 85.0 to 99.0	87 percentages of subjects Interval 70.0 to 96.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenW hSBA ≥ 1:4	100 percentages of subjects Interval 92.0 to 100.0	97 percentages of subjects Interval 83.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenW hSBA ≥ 1:8	100 percentages of subjects Interval 92.0 to 100.0	97 percentages of subjects Interval 83.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenY hSBA ≥ 1:4	98 percentages of subjects Interval 88.0 to 100.0	94 percentages of subjects Interval 79.0 to 99.0	—	—
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenY hSBA ≥ 1:8	95 percentages of subjects Interval 85.0 to 99.0	94 percentages of subjects Interval 79.0 to 99.0	—	—

SECONDARY outcome

Timeframe: 2 years postvaccination

Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=44 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=31 Participants Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenA	21 titers Interval 11.0 to 38.0	19 titers Interval 9.79 to 38.0	—	—
Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenC	133 titers Interval 67.0 to 261.0	61 titers Interval 29.0 to 131.0	—	—
Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenW	95 titers Interval 60.0 to 151.0	114 titers Interval 68.0 to 191.0	—	—
Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine MenY	61 titers Interval 34.0 to 109.0	46 titers Interval 24.0 to 87.0	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 7

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

Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=83 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=77 Participants Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Any Local	40 subjects	40 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Injection site pain	37 subjects	37 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Injection site erythema	6 subjects	7 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events injection site induration	9 subjects	4 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Any systemic	41 subjects	39 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Chills	9 subjects	2 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Nausea	7 subjects	8 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Malaise	4 subjects	8 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Headache	20 subjects	21 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Myalgia	30 subjects	26 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Arthralgia	6 subjects	7 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Rash	0 subjects	0 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Fever ( >= 38C )	2 subjects	0 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Others	15 subjects	9 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Stayed home	2 subjects	1 subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events Analgesic Antipyretic	14 subjects	9 subjects	—	—

SECONDARY outcome

Timeframe: Day 1 to 5 years

Population: Analysis was done on safety follow-up population - subjects enrolled at 5 years were included in the safety follow-up for 24 hours after blood draw and for analysis of medical history to identify new onset of chronic diseases.

Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=284 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=192 Participants Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM n=83 Participants Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM n=77 Participants Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Circulatory system - 21 months	1 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator 3 Years	0 subjects	0 subjects	1 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator 5 Years	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Digestive system- 21 months	4 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Digestive system-21 months through 3 years	1 subjects	0 subjects	2 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Digestive system-3 years through 5 years	3 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Congenital anomalies - 21 months	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Congenital anomalies-21 months through 3 years	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Congenital anomalies-3 years through 5 years	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Endocrine,nutritional,metabolic,immunity- 21 month	2 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Endocrine,nutri,met,immun-21 months through 3years	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Endocrine, nutri,met,immun-3 years through 5 years	2 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Fact. influ. hlth stat & cont. with hlth ser- 21 M	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator 21 months through 3 years	0 subjects	0 subjects	1 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator 3 years through 5 years	1 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Mental disorders - 21 Months	8 subjects	5 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Mental disorders-21 months through 3 years	10 subjects	6 subjects	7 subjects	4 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Mental disorders-3 years through 5 years	9 subjects	5 subjects	2 subjects	2 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Musculoskeletal sys & connective tissue- 21 Months	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Musculoskeletal sys&conn.tissue-21mth through 3yrs	1 subjects	3 subjects	0 subjects	1 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Musculoskeletal sys&conn.tissue-3 yrs through 5yrs	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Nervous system and sense organs - 21 Months	0 subjects	2 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Nervous sys & sense organs-21 mths through 3 years	2 subjects	0 subjects	1 subjects	1 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Nervous sys & sense organs-3 years through 5 years	3 subjects	0 subjects	2 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Pregnancy, childbirth, puerperium - 21 Months	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Pregnancy,childbirth,puerperium-21mths through3yrs	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Pregnancy,childbirth,puerperium-3yrs through 5yrs	1 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Respiratory system - 21 Months	7 subjects	3 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Respiratory system-21 months through 3 years	5 subjects	1 subjects	5 subjects	3 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Respiratory system-3 years through 5 years	7 subjects	2 subjects	1 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Skin and subcutaneous tissue - 21 Months	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Skin &subcutaneous tissue-21 months through 3years	1 subjects	2 subjects	0 subjects	1 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Skin &subcutaneous tissue-3 years through 5 years	2 subjects	2 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Symptoms, signs and ill-defined conditions - 21 M	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Symptoms,signs&ill-defined cond-21mths through3yrs	2 subjects	0 subjects	1 subjects	1 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Symptoms,signs &ill-defined cond-3yrs through 5yrs	4 subjects	3 subjects	0 subjects	1 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Genitourinary system - 21 M	1 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Genitourinary system-21 months through 3 years	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator Genitourinary system-3 years through 5 years	3 subjects	0 subjects	1 subjects	0 subjects

SECONDARY outcome

Timeframe: 28 days postvaccination

Population: Analysis was done on safety population - subjects who received vaccination with MenACWY-CRM conjugate vaccine, provided post-baseline safety data and provide safety follow-up information for any period during the 28 day follow-up.

Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=82 Participants Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=53 Participants Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	MenACWY-CRM/MenACWY-CRM n=81 Participants Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Ear and Labyrinth Disorders- Cerumen Impaction	0 subjects	1 subjects	0 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Gastrointestinal Disorders - Stomatitis	1 subjects	0 subjects	0 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Infections & Infestations - Acarodermatitis	0 subjects	0 subjects	1 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Infections & Infestations -Acute Sinusitis	1 subjects	0 subjects	0 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Infections & Infestations -Chlamydial Infection	0 subjects	0 subjects	1 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Infections & Infestations- Genital Herpes	0 subjects	0 subjects	1 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Infections & Inf-Genitourinary Chlamydia Infection	1 subjects	0 subjects	0 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Infections & Infestations- Herpes Zoster	0 subjects	0 subjects	1 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Infections & Infestations - Oral Herpes	1 subjects	0 subjects	0 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Infections & Infestations - Sinusitis	0 subjects	0 subjects	3 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Infections & Infestations - Urinary Tract Infec	0 subjects	0 subjects	1 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Injury and Poisoning - Arthropod Bite	0 subjects	0 subjects	1 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Investigation - Tuberculin Test	0 subjects	0 subjects	1 subjects	—
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine Skin &Subcutaneous Tissue Dis- Dermatitis Contact	0 subjects	1 subjects	0 subjects	—

Adverse Events

MenACWY-CRM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Licensed Comparator

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Naive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MenACWY-CRM/MenACWY-CRM

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Licensed Comparator /MenACWY-CRM

Serious events: 1 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MenACWY-CRM n=284 participants at risk Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=178 participants at risk Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	Naive n=343 participants at risk Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.	MenACWY-CRM/MenACWY-CRM n=83 participants at risk Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM n=77 participants at risk Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
General disorders Death	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.56% 1/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.
Infections and infestations Appendicitis	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	1.3% 1/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.

Other adverse events

Other adverse events
Measure	MenACWY-CRM n=284 participants at risk Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.	Licensed Comparator n=178 participants at risk Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.	Naive n=343 participants at risk Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.	MenACWY-CRM/MenACWY-CRM n=83 participants at risk Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.	Licensed Comparator /MenACWY-CRM n=77 participants at risk Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Gastrointestinal disorders Nausea	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	10.8% 9/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	10.4% 8/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.
General disorders Chills	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	10.8% 9/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	2.6% 2/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.
General disorders Injection site erythema	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	7.2% 6/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	9.1% 7/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.
General disorders Injection site induration	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	10.8% 9/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	5.2% 4/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.
General disorders Injection site pain	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	44.6% 37/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	48.1% 37/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.
General disorders Malaise	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	4.8% 4/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	10.4% 8/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	7.2% 6/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	9.1% 7/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	36.1% 30/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	33.8% 26/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.
Nervous system disorders Headache	0.00% 0/284 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/178 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	0.00% 0/343 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	25.3% 21/83 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.	27.3% 21/77 • New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years. All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.

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