Trial Outcomes & Findings for Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine (NCT NCT02752906)

Last Updated: 2022-04-05

Results Overview

The serum bactericidal assay using human complement (hSBA) vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

810 participants

Primary outcome timeframe

Day 30 (post-vaccination)

Results posted on

2022-04-05

Participant Flow

Study participants were enrolled in 30 centers from 15 April 2016 to 02 August 2016.

A total of 810 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study.

Participant milestones

Participant milestones
Measure	MenACYW Conjugate Vaccine Healthy, meningococcal vaccine-primed adolescents (greater than or equal to \[\>=\] 15 to less than \[\<\] 18 years) or adults (\>= 18 years) received a single dose of a Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.	Menactra ® Healthy, meningococcal-vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ®) vaccine on Day 0.
Overall Study STARTED	403	407
Overall Study Vaccinated	402	407
Overall Study COMPLETED	396	402
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	MenACYW Conjugate Vaccine Healthy, meningococcal vaccine-primed adolescents (greater than or equal to \[\>=\] 15 to less than \[\<\] 18 years) or adults (\>= 18 years) received a single dose of a Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.	Menactra ® Healthy, meningococcal-vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ®) vaccine on Day 0.
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	2	2
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenACYW Conjugate Vaccine n=403 Participants Healthy, meningococcal vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.	Menactra ® n=407 Participants Healthy, meningococcal-vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.	Total n=810 Participants Total of all reporting groups
Age, Continuous	20.0 Years STANDARD_DEVIATION 5.96 • n=5 Participants	19.9 Years STANDARD_DEVIATION 5.59 • n=7 Participants	20.0 Years STANDARD_DEVIATION 5.77 • n=5 Participants
Sex: Female, Male Female	207 Participants n=5 Participants	200 Participants n=7 Participants	407 Participants n=5 Participants
Sex: Female, Male Male	196 Participants n=5 Participants	207 Participants n=7 Participants	403 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	40 Participants n=5 Participants	46 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) White	342 Participants n=5 Participants	340 Participants n=7 Participants	682 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	17 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	403 Participants n=5 Participants	407 Participants n=7 Participants	810 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30 (post-vaccination)

Population: Per-Protocol Analysis Set-2 (PPAS2): included all participants who had no protocol deviations (not meet inclusion/exclusion criteria, participant did not received vaccine, administration of vaccine not done as per-protocol). PPAS2 defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 30 after vaccination.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=384 Participants Healthy, meningococcal vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.	Menactra ® n=389 Participants Healthy, meningococcal-vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.
Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Serogroup W	98.2 percentage of participants Interval 96.3 to 99.3	90.7 percentage of participants Interval 87.4 to 93.4
Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Serogroup A	92.2 percentage of participants Interval 89.0 to 94.7	87.1 percentage of participants Interval 83.4 to 90.3
Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Serogroup C	97.1 percentage of participants Interval 94.9 to 98.6	91.8 percentage of participants Interval 88.6 to 94.3
Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Serogroup Y	97.4 percentage of participants Interval 95.3 to 98.7	95.6 percentage of participants Interval 93.1 to 97.4

SECONDARY outcome

Timeframe: Day 6 (post-vaccination)

Population: Per-Protocol Analysis Set-1 (PPAS1): included all participants who received at least 1 dose of study vaccine(s) and had no protocol deviations (not meet inclusion/exclusion criteria, participant did not received vaccine). PPAS1 defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 6 after vaccination.

The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=55 Participants Healthy, meningococcal vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.	Menactra ® n=62 Participants Healthy, meningococcal-vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.
Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination Serogroup A	72.7 percentage of participants Interval 59.0 to 83.9	66.1 percentage of participants Interval 53.0 to 77.7
Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination Serogroup C	83.6 percentage of participants Interval 71.2 to 92.2	87.1 percentage of participants Interval 76.1 to 94.3
Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination Serogroup Y	90.9 percentage of participants Interval 80.0 to 97.0	83.9 percentage of participants Interval 72.3 to 92.0
Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination Serogroup W	94.5 percentage of participants Interval 84.9 to 98.9	83.9 percentage of participants Interval 72.3 to 92.0

SECONDARY outcome

Timeframe: Day 30 (post-vaccination)

Population: Analysis was performed on PPAS2.

Meningococcal antibody responses against Serogroups A, C, Y, and W were measured by hSBA.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=384 Participants Healthy, meningococcal vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.	Menactra ® n=389 Participants Healthy, meningococcal-vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.
Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Serogroup A	497 titers (1/dilution) Interval 436.0 to 568.0	296 titers (1/dilution) Interval 256.0 to 343.0
Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Serogroup C	2618 titers (1/dilution) Interval 2227.0 to 3078.0	599 titers (1/dilution) Interval 504.0 to 711.0
Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Serogroup Y	2070 titers (1/dilution) Interval 1807.0 to 2371.0	811 titers (1/dilution) Interval 699.0 to 941.0
Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Serogroup W	1747 titers (1/dilution) Interval 1508.0 to 2025.0	723 titers (1/dilution) Interval 614.0 to 853.0

SECONDARY outcome

Timeframe: Within 7 days post-vaccination

Population: Analysis was performed on Safety Analysis Set which included participants who have received at least one dose of the study vaccine and have any safety data available. Here 'number analyzed' signifies number of participants with available data for specified category.

A Solicited Reaction (SR) was an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema and swelling (Grade 1: \>=25 millimeter \[mm\] to \<= 50 mm, Grade 2: \>=51 to \<=100 mm, Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius (°C) to \<=38.4°C, Grade 2: \>=38.5°C to \<=38.9 °C, Grade 3: \>= 39°C), headache, malaise, and myalgia (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity. Number of participants with any of the Grade (1, 2 or 3) and with each Grade (1, 2 and 3) solicited injection-site and systemic reactions were reported.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=402 Participants Healthy, meningococcal vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.	Menactra ® n=407 Participants Healthy, meningococcal-vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Myalgia-Grade 2	40 Participants	27 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Pain-Any Grade	178 Participants	196 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Pain-Grade 1	141 Participants	154 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Pain-Grade 2	33 Participants	34 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Pain-Grade 3	4 Participants	8 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Erythema-Any Grade	20 Participants	6 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Erythema-Grade 1	18 Participants	5 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Erythema-Grade 2	2 Participants	1 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Erythema-Grade 3	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Swelling-Any Grade	16 Participants	3 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Swelling-Grade 1	13 Participants	1 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Swelling-Grade 2	3 Participants	2 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Swelling-Grade 3	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Fever-Any Grade	0 Participants	2 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Fever-Grade 1	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Fever-Grade 2	0 Participants	1 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Fever-Grade 3	0 Participants	1 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Headache-Any Grade	151 Participants	134 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Headache-Grade 1	90 Participants	73 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Headache-Grade 2	52 Participants	47 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Headache-Grade 3	9 Participants	14 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Malaise-Any Grade	110 Participants	108 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Malaise-Grade 1	62 Participants	64 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Malaise-Grade 2	37 Participants	30 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Malaise-Grade 3	11 Participants	14 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Myalgia-Any Grade	146 Participants	156 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Myalgia-Grade 1	98 Participants	120 Participants
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Myalgia-Grade 3	8 Participants	9 Participants

Adverse Events

Group 1: MenACYW Conjugate Vaccine

Serious events: 5 serious events

Other events: 255 other events

Deaths: 0 deaths

Group 2: Menactra ®

Serious events: 4 serious events

Other events: 263 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: MenACYW Conjugate Vaccine n=402 participants at risk Healthy, meningococcal-vaccine naive adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.	Group 2: Menactra ® n=407 participants at risk Healthy, meningococcal-vaccine naive adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Menactra vaccine on Day 0.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/402 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	0.25% 1/407 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
General disorders Chest Pain	0.00% 0/402 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	0.25% 1/407 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
Hepatobiliary disorders Cholelithiasis	0.25% 1/402 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	0.00% 0/407 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
Immune system disorders Allergy To Arthropod Sting	0.25% 1/402 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	0.00% 0/407 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
Infections and infestations Appendicitis	0.25% 1/402 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	0.00% 0/407 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
Injury, poisoning and procedural complications Clavicle Fracture	0.25% 1/402 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	0.00% 0/407 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
Psychiatric disorders Major Depression	0.00% 0/402 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	0.25% 1/407 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
Psychiatric disorders Suicidal Ideation	0.00% 0/402 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	0.25% 1/407 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.25% 1/402 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	0.00% 0/407 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.

Other adverse events

Other adverse events
Measure	Group 1: MenACYW Conjugate Vaccine n=402 participants at risk Healthy, meningococcal-vaccine naive adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.	Group 2: Menactra ® n=407 participants at risk Healthy, meningococcal-vaccine naive adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Menactra vaccine on Day 0.
General disorders Injection Site Pain	44.3% 178/402 • Number of events 178 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	48.2% 196/407 • Number of events 196 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
General disorders Malaise	27.4% 110/402 • Number of events 110 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	26.5% 108/407 • Number of events 108 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
Musculoskeletal and connective tissue disorders Myalgia	36.6% 147/402 • Number of events 148 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	38.8% 158/407 • Number of events 161 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
Nervous system disorders Headache	38.6% 155/402 • Number of events 168 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.	33.7% 137/407 • Number of events 152 • Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.

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