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Clinical Trial Results:
A Phase 3, Randomized, Active-Controlled, Observer-Blinded Trial To Assess The Safety, Tolerability, And Immunogenicity Of MenABCWY In Healthy Participants >=10 To <26 Years Of Age

Summary
EudraCT number	2019-004313-13
Trial protocol	DK CZ HU PL
Global end of trial date	24 Jul 2022

Results information
Results version number	v1(current)
This version publication date	09 Feb 2023
First version publication date	09 Feb 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

C3511001

ISRCTN number

US NCT number

NCT04440163

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

29 Sep 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

24 Jul 2022

Was the trial ended prematurely?

Main objective of the trial

Immunogenicity: 1. To demonstrate that the immune response for Neisseria meningitidis group A (MenA), Neisseria meningitidis group C (MenC), Neisseria meningitidis group W (MenW), and Neisseria meningitidis group Y (MenY) induced by 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY ) is noninferior to the immune response induced by 1 dose of meningococcal groups A, C, Y, and W-135 oligosaccharide diphtheria conjugate vaccine (MenACWY-CRM) in both ACWY-naïve and ACWY-experienced participants, separately. 2. To demonstrate that the immune response for MenB induced by 2 doses of MenABCWY is noninferior to the immune response induced by 2 doses of Trumenba. Safety: To describe the safety profile of MenABCWY, as measured by local reactions, systemic events, adverse events (AEs), serious adverse events (SAEs), newly diagnosed chronic medical conditions (NDCMCs), medically attended adverse event (MAEs), and immediate AEs.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

17 Jun 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Czechia: 244

Country: Number of subjects enrolled

Denmark: 96

Country: Number of subjects enrolled

Hungary: 106

Country: Number of subjects enrolled

Poland: 218

Country: Number of subjects enrolled

United States: 1748

Worldwide total number of subjects

2412

EEA total number of subjects

664

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

606

Adolescents (12-17 years)

991

Adults (18-64 years)

815

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

A total of 2431 subjects were enrolled and randomised in the study of which 18 subjects did not receive any vaccination. 2413 subjects received at least 1 dose of vaccination. 1 subject initially randomised to group 3 was excluded from safety population set as the subject received the wrong vaccination (Trumenba + saline).

Period 1 title

Vaccination Phase

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

ACWY-Naive: Group 1 MenABCWY + Saline

Arm description

On Day 1, Neisseria meningitidis group A, C, W, and Y (ACWY) naive subjects received a single dose of 0.5 millilitre (mL) Neisseria meningitidis serogroup A, B, C, W, Y (MenABCWY) intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). After 6 months, subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Arm type

Experimental

Investigational medicinal product name

Saline

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of saline intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Arm description

On Day 1, ACWY naive subjects received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria conjugate vaccine (MenACWY-CRM) intramuscularly into the right deltoid muscle (Vaccination 1). After 6 months, subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Arm type

Experimental

Investigational medicinal product name

MenACWY - CRM

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

Trumenba

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Experienced: Group 3 MenABCWY + Saline

Arm description

On Day 1, ACWY experienced subjects received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). After 6 months, subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Arm type

Experimental

Investigational medicinal product name

Saline

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of saline intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Arm description

On Day 1, ACWY experienced subjects received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). After 6 months, subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Arm type

Experimental

Investigational medicinal product name

MenACWY - CRM

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

Trumenba

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Naive: Group 5 MenABCWY + Saline

Arm description

On Day 1, ACWY naive subjects received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). After 6 months, subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to safety analyses only.

Arm type

Experimental

Investigational medicinal product name

Saline

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of saline intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM

Arm description

On Day 1, ACWY naive subjects received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). After 6 months, subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to safety analyses only.

Arm type

Experimental

Investigational medicinal product name

MenACWY - CRM

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

Trumenba

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Experienced: Group 7 MenABCWY + Saline

Arm description

Arm type

Experimental

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle at Visits 1 and 3.

Investigational medicinal product name

Saline

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of saline intramuscularly into the right deltoid muscle at Visit 1.

ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM

Arm description

Arm type

Experimental

Investigational medicinal product name

Trumenba

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle at Visits 1 and 3.

Investigational medicinal product name

MenACWY - CRM

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle at Visit 1.

Number of subjects in period 1	ACWY-Naive: Group 1 MenABCWY + Saline	ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM	ACWY-Experienced: Group 3 MenABCWY + Saline	ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM	ACWY-Naive: Group 5 MenABCWY + Saline	ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM	ACWY-Experienced: Group 7 MenABCWY + Saline	ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM
Started	547	274	526	260	537	56	153	59
Completed	490	248	440	209	476	45	122	44
Not completed	57	26	86	51	61	11	31	15
Consent withdrawn by subject	11	5	18	14	10	3	5	4
No longer met eligibility criteria	5	1	5	2	3	-	2	3
Pregnancy	1	-	2	-	1	-	-	-
Medication error without associated adverse event	-	-	1	-	1	-	-	-
Adverse event	3	1	-	1	-	-	-	-
Unspecified	-	-	3	2	-	1	-	1
Lost to follow-up	26	15	42	22	30	3	18	5
Withdrawal by parent/guardian	10	4	10	7	16	4	3	2
Protocol deviation	1	-	5	3	-	-	3	-

Period 2 title

Follow-up Phase

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

ACWY-Naive: Group 1 MenABCWY + Saline

Arm description

On Day 1, ACWY naive subjects received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid along with 0.5 mL of saline intramuscularly into the right deltoid (Vaccination 1). After 6 months, subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Arm type

Experimental

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle at Visits 1 and 3.

Investigational medicinal product name

Saline

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of saline intramuscularly into the right deltoid muscle at Visit 1.

ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Arm description

On Day 1, ACWY naive subjects received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid (Vaccination 1). After 6 months, subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Arm type

Experimental

Investigational medicinal product name

MenACWY - CRM

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

Trumenba

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Experienced: Group 3 MenABCWY + Saline

Arm description

On Day 1, ACWY experienced subjects received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid along with 0.5 mL of saline intramuscularly into the right deltoid (Vaccination 1). After 6 months, subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Arm type

Experimental

Investigational medicinal product name

Saline

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of saline intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Arm description

On Day 1, ACWY experienced subjects received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid (Vaccination 1). After 6 months, subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Arm type

Experimental

Investigational medicinal product name

MenACWY - CRM

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

Trumenba

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Naive: Group 5 MenABCWY + Saline

Arm description

Arm type

Experimental

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle at Visits 1 and 3.

Investigational medicinal product name

Saline

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of saline intramuscularly into the right deltoid muscle at Visit 1.

ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM

Arm description

Arm type

Experimental

Investigational medicinal product name

MenACWY - CRM

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid at Visit 1.

Investigational medicinal product name

Trumenba

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Experienced: Group 7 MenABCWY + Saline

Arm description

Arm type

Experimental

Investigational medicinal product name

Saline

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of saline intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle at Visits 1 and 3.

ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM

Arm description

Arm type

Experimental

Investigational medicinal product name

MenACWY - CRM

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle at Visit 1.

Investigational medicinal product name

Trumenba

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle at Visits 1 and 3.

Number of subjects in period 2	ACWY-Naive: Group 1 MenABCWY + Saline	ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM	ACWY-Experienced: Group 3 MenABCWY + Saline	ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM	ACWY-Naive: Group 5 MenABCWY + Saline	ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM	ACWY-Experienced: Group 7 MenABCWY + Saline	ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM
Started	490	248	440	209	476	45	122	44
Completed	487	243	440	208	475	45	120	43
Not completed	3	5	0	1	1	0	2	1
Lost to follow-up	3	5	-	-	1	-	2	1
Protocol deviation	-	-	-	1	-	-	-	-

Baseline characteristics

Top of page

Reporting group title

ACWY-Naive: Group 1 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Experienced: Group 3 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Naive: Group 5 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Experienced: Group 7 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group values	ACWY-Naive: Group 1 MenABCWY + Saline	ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM	ACWY-Experienced: Group 3 MenABCWY + Saline	ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM	ACWY-Naive: Group 5 MenABCWY + Saline	ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM	ACWY-Experienced: Group 7 MenABCWY + Saline	ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM	Total
Number of subjects	547	274	526	260	537	56	153	59	2412
Age Categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0
Children (2-11 years)	187	89	16	9	264	30	5	6	606
Adolescents (12-17 years)	72	43	354	173	186	14	104	45	991
Adults (18-64 years)	288	142	156	78	87	12	44	8	815
From 65-84 years	0	0	0	0	0	0	0	0	0
85 years and over	0	0	0	0	0	0	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	16.7 ( 5.49 )	16.7 ( 5.39 )	17.3 ( 3.17 )	17.4 ( 3.28 )	13.5 ( 4.05 )	13.5 ( 4.50 )	17.1 ( 3.04 )	16.0 ( 2.75 )	-
Gender Categorical
Units: Subjects
Female	289	140	279	131	253	20	96	28	1236
Male	258	134	247	129	284	36	57	31	1176
Race
Units: Subjects
White	467	239	370	195	419	46	103	42	1881
Black or African American	26	19	74	32	57	5	27	5	245
Asian	19	4	18	6	7	1	1	1	57
American Indian or Alaska Native	2	2	2	2	4	1	2	1	16
Native Hawaiian or other Pacific Islander	1	0	2	0	1	0	0	0	4
Multiracial	9	3	12	3	7	2	2	0	38
Not reported	23	7	48	22	42	1	18	10	171
Ethnicity
Units: Subjects
Hispanic/Latino	93	53	156	86	131	15	58	29	621
Non- Hispanic/non- Latino	450	217	366	173	405	41	93	30	1775
Not reported	4	4	4	1	1	0	2	0	16

End points

Top of page

Reporting group title

ACWY-Naive: Group 1 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Experienced: Group 3 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Naive: Group 5 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Experienced: Group 7 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Naive: Group 1 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Experienced: Group 3 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Naive: Group 5 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Experienced: Group 7 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM

Reporting group description

Subject analysis set title

Groups 1+3 Combined MenABCWY + Saline

Subject analysis set type

Sub-group analysis

Subject analysis set description

On Day 1, ACWY naive and ACWY experienced subjects received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). After 6 months, subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Subject analysis set title

Groups 2+4 Combined Trumenba + MenACWY-CRM

Subject analysis set type

Sub-group analysis

Subject analysis set description

On Day 1, ACWY naive and ACWY experienced subjects received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). After 6 months, subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Subject analysis set title

Groups 1+3+5+7 Combined MenABCWY + Saline

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM

Subject analysis set type

Sub-group analysis

Subject analysis set description

Primary: Percentage of Subjects Achieving At least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2

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End point title

Percentage of Subjects Achieving At least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2 ^[1]

End point description

4-fold increase was defined as: for subjects with baseline hSBA titer below limit of detection (LOD) (or hSBA titer <1:4),response=hSBA titer >=1:16;baseline hSBA titer >=LOD and < lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), response=hSBA titer >=4times LLOQ; baseline hSBA titer >=LLOQ, response=hSBA titer >=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Post-vaccination(PV) 1 and PV2 evaluable immunogenicity population for Group 2 and Group 1 included subjects randomised to study group of interest; eligible at visit(V) 2 and 4, respectively; received vaccine at V1 or V1 and V3, respectively; blood drawn for assay testing at protocol-specified time points; at least 1 valid, determinate MenACWY or MenACWY/MenB assay result, received no prohibited vaccines/treatment and had no protocol deviations through V2 and V4 respectively. N= subjects evaluable for end point; n=subjects evaluable for specified rows.

End point type

Primary

End point timeframe

1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for specified reporting arms.

End point values	ACWY-Naive: Group 1 MenABCWY + Saline	ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM
Number of subjects analysed	451	254
Units: Percentage of subjects
number (confidence interval 95%)
MenA (n=447, 254)	97.8 (95.9 to 98.9)	95.3 (91.9 to 97.5)
MenC (n=451, 252)	93.3 (90.6 to 95.5)	52.4 (46.0 to 58.7)
MenW (n=439, 244)	97.3 (95.3 to 98.6)	73.0 (66.9 to 78.4)
MenY (n=446, 248)	94.4 (91.8 to 96.3)	70.6 (64.5 to 76.2)

MenA (Group 1 Vs Group 2)

Comparison groups

ACWY-Naive: Group 1 MenABCWY + Saline v ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

705

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[2]

Method

Parameter type

Difference in percentage

Point estimate

2.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

Notes
[2] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was greater than (>) -10 percent (%), the non-inferiority was concluded.

MenC (Group 1 Vs Group 2)

Comparison groups

ACWY-Naive: Group 1 MenABCWY + Saline v ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

705

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[3]

Method

Parameter type

Difference in percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

34.4

upper limit

47.5

Notes
[3] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenW (Group 1 Vs Group 2)

Comparison groups

ACWY-Naive: Group 1 MenABCWY + Saline v ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

705

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[4]

Method

Parameter type

Difference in percentage

Point estimate

24.3

Confidence interval

level

95%

sides

2-sided

lower limit

18.8

upper limit

30.4

Notes
[4] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenY (Group 1 Vs Group 2)

Comparison groups

ACWY-Naive: Group 1 MenABCWY + Saline v ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

705

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[5]

Method

Parameter type

Difference in percentage

Point estimate

23.8

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

30.1

Notes
[5] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

Primary: Percentage of Subjects Achieving At least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4

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End point title

Percentage of Subjects Achieving At least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4 ^[6]

End point description

4-fold increase was defined as: for subjects with baseline hSBA titer below LOD (or hSBA titer <1:4),response=hSBA titer >=1:16;baseline hSBA titer >=LOD (ie, hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), response=hSBA titer >=4times LLOQ; baseline hSBA titer >=LLOQ, response=hSBA titer >=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Post-vaccination(PV) 1 and PV2 evaluable immunogenicity population for Group 4 and Group 3 included subjects randomised to study group of interest; eligible at visit(V) 2 and 4, respectively; received vaccine at V1 or V1 and V3, respectively; blood drawn for assay testing at protocol-specified time points; at least 1 valid, determinate MenACWY or MenACWY/MenB assay result, received no prohibited vaccines/treatment and had no protocol deviations through V2 and V4 respectively. N= subjects evaluable for end point; n=subjects evaluable for specified rows.

End point type

Primary

End point timeframe

1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for specified reporting arms.

End point values	ACWY-Experienced: Group 3 MenABCWY + Saline	ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM
Number of subjects analysed	387	227
Units: Percentage of subjects
number (confidence interval 95%)
MenA (n=385, 227)	93.8 (90.9 to 96.0)	96.9 (93.7 to 98.8)
MenC (n=386, 226)	93.8 (90.9 to 96.0)	94.7 (90.9 to 97.2)
MenW (n=376, 222)	97.1 (94.8 to 98.5)	96.4 (93.0 to 98.4)
MenY (n=387, 223)	93.0 (90.0 to 95.4)	93.7 (89.7 to 96.5)

MenA (Group 3 Vs Group 4)

Comparison groups

ACWY-Experienced: Group 3 MenABCWY + Saline v ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

614

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[7]

Method

Parameter type

Difference in percentage

Point estimate

-3.2

Confidence interval

level

95%

sides

2-sided

lower limit

-6.5

upper limit

0.5

Notes
[7] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenW (Group 3 Vs Group 4)

Comparison groups

ACWY-Experienced: Group 3 MenABCWY + Saline v ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

614

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[8]

Method

Parameter type

Difference in percentage

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

4.3

Notes
[8] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenY (Group 3 Vs Group 4)

Comparison groups

ACWY-Experienced: Group 3 MenABCWY + Saline v ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

614

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[9]

Method

Parameter type

Difference in percentage

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-4.6

upper limit

3.8

Notes
[9] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenC (Group 3 Vs Group 4)

Comparison groups

ACWY-Experienced: Group 3 MenABCWY + Saline v ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

614

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[10]

Method

Parameter type

Difference in percentage

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-4.6

upper limit

3.3

Notes
[10] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

Primary: Percentage of Subjects Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for all Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined

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End point title

Percentage of Subjects Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for all Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined

End point description

Percentage of subjects achieving hSBA titer >= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this endpoint. Exact 2-sided CI based using the Clopper and Pearson method was presented. PV2 evaluable immunogenicity population: subjects randomized to study group of interest; eligible at V4;received vaccine at V1 and V3;blood drawn for assay testing at protocol-specified time points; had at least 1 valid, determinate MenACWY or MenB assay result at V4; received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analyzed’ (N)=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

1 month after Vaccination 2

End point values	Groups 1+3 Combined MenABCWY + Saline	Groups 2+4 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	755	383
Units: Percentage of subjects
number (confidence interval 95%)	78.3 (75.2 to 81.2)	68.7 (63.8 to 73.3)

Groups 1+3 Vs Groups 2+4

Comparison groups

Groups 1+3 Combined MenABCWY + Saline v Groups 2+4 Combined Trumenba + MenACWY-CRM

Number of subjects included in analysis

1138

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[11]

Method

Parameter type

Difference in percentage

Point estimate

9.6

Confidence interval

level

95%

sides

2-sided

lower limit

4.2

upper limit

15.2

Notes
[11] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

Primary: Percentage of Subjects Achieving At least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined

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End point title

Percentage of Subjects Achieving At least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined

End point description

Percentage of subjects achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this endpoint. Exact 2-sided CI based using the Clopper and Pearson method was presented. PV2 evaluable immunogenicity population: subjects randomized to study group of interest; eligible at V4;received vaccine at V1 and V3;blood drawn for assay testing at protocol-specified time points; had at least 1 valid, determinate MenACWY or MenB assay result at V4; received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, N=subjects evaluable for this endpoint. n=subjects evaluable for specified rows.

End point type

Primary

End point timeframe

1 month after Vaccination 2

End point values	Groups 1+3 Combined MenABCWY + Saline	Groups 2+4 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	845	419
Units: Percentage of subjects
number (confidence interval 95%)
A22 (n=778, 396)	83.0 (80.2 to 85.6)	79.0 (74.7 to 82.9)
A56 (n=807, 400)	95.9 (94.3 to 97.2)	94.5 (91.8 to 96.5)
B24 (n=833, 418)	68.1 (64.8 to 71.2)	57.2 (52.3 to 62.0)
B44 (n=845, 419)	86.5 (84.0 to 88.7)	79.2 (75.0 to 83.0)

A22 (Groups 1+3 Vs Groups 2+4)

Comparison groups

Groups 1+3 Combined MenABCWY + Saline v Groups 2+4 Combined Trumenba + MenACWY-CRM

Number of subjects included in analysis

1264

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[12]

Method

Parameter type

Difference in percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

8.9

Notes
[12] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

A56 (Groups 1+3 Vs Groups 2+4)

Comparison groups

Groups 1+3 Combined MenABCWY + Saline v Groups 2+4 Combined Trumenba + MenACWY-CRM

Number of subjects included in analysis

1264

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[13]

Method

Parameter type

Difference in percentage

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

4.3

Notes
[13] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

B24 (Groups 1+3 Vs Groups 2+4)

Comparison groups

Groups 1+3 Combined MenABCWY + Saline v Groups 2+4 Combined Trumenba + MenACWY-CRM

Number of subjects included in analysis

1264

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[14]

Method

Parameter type

Difference in percentage

Point estimate

10.9

Confidence interval

level

95%

sides

2-sided

lower limit

5.2

upper limit

16.6

Notes
[14] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

B44 (Groups 1+3 Vs Groups 2+4)

Comparison groups

Groups 1+3 Combined MenABCWY + Saline v Groups 2+4 Combined Trumenba + MenACWY-CRM

Number of subjects included in analysis

1264

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[15]

Method

Parameter type

Difference in percentage

Point estimate

7.3

Confidence interval

level

95%

sides

2-sided

lower limit

2.9

upper limit

11.9

Notes
[15] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[16]

End point description

Local reactions included pain at injection site, redness and swelling and were recorded by subjects in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of subjects with local reactions at injection site on left arm were reported in this endpoint. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ‘Number of Subjects Analysed’ (N)=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Within 7 days after Vaccination 1

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1722	630
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Mild	8.8 (7.5 to 10.3)	7.3 (5.4 to 9.6)
Redness: Moderate	14.5 (12.8 to 16.2)	10.0 (7.8 to 12.6)
Redness: Severe	2.5 (1.8 to 3.3)	2.2 (1.2 to 3.7)
Swelling: Mild	10.5 (9.0 to 12.0)	8.3 (6.2 to 10.7)
Swelling: Moderate	13.3 (11.7 to 15.0)	12.4 (9.9 to 15.2)
Swelling: Severe	1.2 (0.7 to 1.8)	0.8 (0.3 to 1.8)
Pain at injection site: Mild	32.3 (30.1 to 34.6)	31.1 (27.5 to 34.9)
Pain at injection site: Moderate	49.5 (47.1 to 51.9)	47.6 (43.7 to 51.6)
Pain at injection site: Severe	7.5 (6.3 to 8.8)	6.3 (4.6 to 8.5)

No statistical analyses for this end point

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[17]

End point description

Local reactions included pain at injection site, redness and swelling and were recorded by subjects in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of subjects with local reactions at injection site on left arm were reported in this endpoint. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ‘Number of Subjects Analysed’ (N)=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Within 7 days after Vaccination 2

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1456	529
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Mild	7.7 (6.4 to 9.2)	6.6 (4.7 to 9.1)
Redness: Moderate	12.6 (10.9 to 14.4)	7.2 (5.1 to 9.7)
Redness: Severe	3.0 (2.1 to 4.0)	0.9 (0.3 to 2.2)
Swelling: Mild	10.4 (8.9 to 12.1)	6.4 (4.5 to 8.9)
Swelling: Moderate	12.8 (11.1 to 14.6)	8.1 (5.9 to 10.8)
Swelling: Severe	1.0 (0.5 to 1.6)	0.2 (0.0 to 1.0)
Pain at injection site: Mild	29.1 (26.7 to 31.5)	33.1 (29.1 to 37.3)
Pain at injection site: Moderate	48.8 (46.2 to 51.4)	40.3 (36.1 to 44.6)
Pain at injection site: Severe	6.5 (5.3 to 7.9)	5.3 (3.5 to 7.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[18]

End point description

Systemic events were recorded by subjects in e-diary. Fever was defined as temperature >=38.0 degrees(deg) Celsius(C) and was categorised as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ‘Number of Subjects Analysed’ (N)=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Within 7 days after Vaccination 1

Notes
[18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1739	638
Units: Percentage of subjects
number (confidence interval 95%)
Fever: 38.0 deg C to 38.4 deg C	3.7 (2.8 to 4.7)	2.0 (1.1 to 3.5)
Fever: >38.4 deg C to 38.9 deg C	1.6 (1.0 to 2.3)	2.8 (1.7 to 4.4)
Fever: >38.9 deg C to 40.0 deg C	0.6 (0.3 to 1.1)	0.9 (0.3 to 2.0)
Fever: >40.0 deg C	0.0 (0.0 to 0.2)	0.0 (0.0 to 0.6)
Fatigue: Mild	23.5 (21.5 to 25.5)	25.7 (22.4 to 29.3)
Fatigue: Moderate	25.5 (23.4 to 27.6)	25.7 (22.4 to 29.3)
Fatigue: Severe	3.2 (2.4 to 4.1)	3.3 (2.0 to 5.0)
Headache: Mild	25.6 (23.6 to 27.8)	24.5 (21.2 to 28.0)
Headache: Moderate	19.2 (17.4 to 21.1)	20.4 (17.3 to 23.7)
Headache: Severe	1.9 (1.3 to 2.7)	2.0 (1.1 to 3.5)
Chills: Mild	12.6 (11.1 to 14.2)	10.2 (8.0 to 12.8)
Chills: Moderate	6.7 (5.5 to 7.9)	7.8 (5.9 to 10.2)
Chills: Severe	0.8 (0.4 to 1.3)	1.6 (0.8 to 2.9)
Vomiting: Mild	2.5 (1.8 to 3.4)	2.0 (1.1 to 3.5)
Vomiting: Moderate	0.6 (0.3 to 1.1)	0.9 (0.3 to 2.0)
Vomiting: Severe	0.0 (0.0 to 0.2)	0.0 (0.0 to 0.6)
Diarrhea: Mild	8.7 (7.5 to 10.2)	11.9 (9.5 to 14.7)
Diarrhea: Moderate	2.0 (1.4 to 2.7)	1.6 (0.8 to 2.9)
Diarrhea: Severe	0.3 (0.1 to 0.7)	0.0 (0.0 to 0.6)
Muscle Pain: Mild	13.6 (12.0 to 15.3)	13.5 (10.9 to 16.4)
Muscle Pain: Moderate	10.5 (9.1 to 12.1)	11.9 (9.5 to 14.7)
Muscle Pain: Severe	1.6 (1.1 to 2.3)	2.0 (1.1 to 3.5)
Joint Pain: Mild	10.7 (9.3 to 12.2)	12.9 (10.4 to 15.7)
Joint Pain: Moderate	8.6 (7.3 to 10.0)	8.6 (6.6 to 11.1)
Joint Pain: Severe	1.0 (0.6 to 1.6)	1.1 (0.4 to 2.2)

No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[19]

End point description

Systemic events were recorded by subjects in e-diary. Fever was defined as temperature >=38.0 deg C and was categorised as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ‘Number of Subjects Analysed’ (N)=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Within 7 days after Vaccination 2

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1459	532
Units: Percentage of subjects
number (confidence interval 95%)
Fever: 38.0 deg C to 38.4 deg C	1.8 (1.2 to 2.6)	0.4 (0.0 to 1.4)
Fever: >38.4 deg C to 38.9 deg C	0.3 (0.1 to 0.7)	0.9 (0.3 to 2.2)
Fever: >38.9 deg C to 40.0 deg C	0.2 (0.0 to 0.6)	0.2 (0.0 to 1.0)
Fever: >40.0 deg C	0.0 (0.0 to 0.3)	0.0 (0.0 to 0.7)
Fatigue: Mild	22.8 (20.7 to 25.1)	22.0 (18.5 to 25.8)
Fatigue: Moderate	21.8 (19.7 to 24.0)	19.9 (16.6 to 23.6)
Fatigue: Severe	2.9 (2.1 to 3.9)	1.7 (0.8 to 3.2)
Headache: Mild	21.3 (19.2 to 23.5)	21.1 (17.7 to 24.8)
Headache: Moderate	16.8 (14.9 to 18.8)	16.2 (13.1 to 19.6)
Headache: Severe	1.7 (1.1 to 2.5)	0.6 (0.1 to 1.6)
Chills: Mild	9.9 (8.5 to 11.6)	8.8 (6.6 to 11.6)
Chills: Moderate	6.0 (4.9 to 7.4)	5.8 (4.0 to 8.2)
Chills: Severe	0.4 (0.2 to 0.9)	1.5 (0.7 to 2.9)
Vomiting: Mild	1.4 (0.8 to 2.1)	0.8 (0.2 to 1.9)
Vomiting: Moderate	0.1 (0.0 to 0.5)	0.2 (0.0 to 1.0)
Vomiting: Severe	0.0 (0.0 to 0.3)	0.0 (0.0 to 0.7)
Diarrhea: Mild	6.9 (5.6 to 8.3)	6.0 (4.2 to 8.4)
Diarrhea: Moderate	1.4 (0.8 to 2.1)	2.4 (1.3 to 4.1)
Diarrhea: Severe	0.0 (0.0 to 0.3)	0.0 (0.0 to 0.7)
Muscle Pain: Mild	10.0 (8.5 to 11.7)	10.0 (7.6 to 12.8)
Muscle Pain: Moderate	11.9 (10.3 to 13.7)	11.5 (8.9 to 14.5)
Muscle Pain: Severe	0.8 (0.4 to 1.4)	0.8 (0.2 to 1.9)
Joint Pain: Mild	9.6 (8.1 to 11.2)	7.9 (5.7 to 10.5)
Joint Pain: Moderate	8.3 (6.9 to 9.8)	6.8 (4.8 to 9.2)
Joint Pain: Severe	0.4 (0.2 to 0.9)	0.9 (0.3 to 2.2)

No statistical analyses for this end point

Primary: Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[20]

End point description

The use of antipyretic medication was recorded by subjects in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ‘Number of Subjects Analysed’ (N)=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Within 7 days after Vaccination 1

Notes
[20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1739	638
Units: Percentage of subjects
number (confidence interval 95%)	29.5 (27.4 to 31.7)	28.1 (24.6 to 31.7)

No statistical analyses for this end point

Primary: Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[21]

End point description

The use of antipyretic medication recorded by subjects in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ‘Number of Subjects Analysed’ (N)=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Within 7 days after Vaccination 2

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1459	532
Units: Percentage of subjects
number (confidence interval 95%)	25.1 (22.9 to 27.4)	20.5 (17.1 to 24.2)

No statistical analyses for this end point

Primary: Percentage of Subjects With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[22]

End point description

An AE was any untoward medical occurrence in a subject, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination.

End point type

Primary

End point timeframe

Within 30 days after Vaccination 1

Notes
[22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	5.8 (4.7 to 7.0)	6.5 (4.7 to 8.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[23]

End point description

End point type

Primary

End point timeframe

Within 30 days after Vaccination 2

Notes
[23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1558	562
Units: Percentage of subjects
number (confidence interval 95%)	5.3 (4.3 to 6.6)	3.7 (2.3 to 5.7)

No statistical analyses for this end point

Primary: Percentage of Subjects With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[24]

End point description

End point type

Primary

End point timeframe

Within 30 days after any Vaccination

Notes
[24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	9.7 (8.4 to 11.2)	9.1 (7.0 to 11.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[25]

End point description

End point type

Primary

End point timeframe

From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2

Notes
[25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	20.9 (19.0 to 22.8)	20.3 (17.3 to 23.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[26]

End point description

An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination.

End point type

Primary

End point timeframe

Within 30 days after Vaccination 1

Notes
[26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	0.06 (0.0 to 0.3)	0.0 (0.0 to 0.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[27]

End point description

End point type

Primary

End point timeframe

Within 30 days after Vaccination 2

Notes
[27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1558	562
Units: Percentage of subjects
number (confidence interval 95%)	0.1 (0.0 to 0.5)	0.0 (0.0 to 0.7)

No statistical analyses for this end point

Primary: Percentage of Subjects With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[28]

End point description

An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination.

End point type

Primary

End point timeframe

From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2

Notes
[28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	0.4 (0.2 to 0.8)	0.0 (0.0 to 0.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[29]

End point description

An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination.

End point type

Primary

End point timeframe

Within 30 days after any Vaccination

Notes
[29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	0.2 (0.0 to 0.5)	0.0 (0.0 to 0.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[30]

End point description

An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ‘Number of Subjects Analysed’ (N)=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

From 1 month after Vaccination 2 up to 6 months after Vaccination 2

Notes
[30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1390	509
Units: Percentage of subjects
number (confidence interval 95%)	0.3 (0.1 to 0.7)	0.8 (0.2 to 2.0)

No statistical analyses for this end point

Primary: Percentage of Subjects With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[31]

End point description

An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination.

End point type

Primary

End point timeframe

From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2

Notes
[31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	0.6 (0.3 to 1.1)	0.6 (0.2 to 1.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[32]

End point description

MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination.

End point type

Primary

End point timeframe

Within 30 days after Vaccination 1

Notes
[32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	3.6 (2.8 to 4.5)	4.3 (2.9 to 6.2)

No statistical analyses for this end point

Primary: Percentage of Subjects With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[33]

End point description

End point type

Primary

End point timeframe

Within 30 days after Vaccination 2

Notes
[33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1558	562
Units: Percentage of subjects
number (confidence interval 95%)	3.6 (2.7 to 4.6)	2.8 (1.6 to 4.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[34]

End point description

End point type

Primary

End point timeframe

Within 30 days after any Vaccination

Notes
[34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	6.3 (5.2 to 7.5)	6.3 (4.6 to 8.5)

No statistical analyses for this end point

Primary: Percentage of Subjects With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[35]

End point description

End point type

Primary

End point timeframe

From 1 month after Vaccination 2 up to 6 months after Vaccination 2

Notes
[35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1390	509
Units: Percentage of subjects
number (confidence interval 95%)	9.3 (7.8 to 10.9)	7.5 (5.3 to 10.1)

No statistical analyses for this end point

Primary: Percentage of Subjects With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[36]

End point description

End point type

Primary

End point timeframe

From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2

Notes
[36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analyzed only for specified reporting arms.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	14.9 (13.3 to 16.7)	14.3 (11.7 to 17.3)

No statistical analyses for this end point

Primary: Percentage of Subjects With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Top of page

End point title

Percentage of Subjects With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[37]

End point description

End point type

Primary

End point timeframe

From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2

Notes
[37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	19.3 (17.5 to 21.2)	18.3 (15.4 to 21.5)

No statistical analyses for this end point

Primary: Percentage of Subjects With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[38]

End point description

An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination.

End point type

Primary

End point timeframe

Within 30 days after Vaccination 1

Notes
[38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	0.2 (0.1 to 0.6)	0.0 (0.0 to 0.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[39]

End point description

End point type

Primary

End point timeframe

Within 30 days after Vaccination 2

Notes
[39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1558	562
Units: Percentage of subjects
number (confidence interval 95%)	0.06 (0.0 to 0.4)	0.0 (0.0 to 0.7)

No statistical analyses for this end point

Primary: Percentage of Subjects With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[40]

End point description

End point type

Primary

End point timeframe

Within 30 Days after any Vaccination

Notes
[40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	0.3 (0.1 to 0.7)	0.0 (0.0 to 0.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[41]

End point description

End point type

Primary

End point timeframe

From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2

Notes
[41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	1.1 (0.7 to 1.7)	0.3 (0.0 to 1.1)

No statistical analyses for this end point

Primary: Percentage of Subjects With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[42]

End point description

End point type

Primary

End point timeframe

From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2

Notes
[42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	1.4 (0.9 to 2.1)	0.3 (0.0 to 1.1)

No statistical analyses for this end point

Primary: Percentage of Subjects With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[43]

End point description

End point type

Primary

End point timeframe

From 1 month after Vaccination 2 up to 6 months after Vaccination 2

Notes
[43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1390	509
Units: Percentage of subjects
number (confidence interval 95%)	0.4 (0.1 to 0.8)	0.0 (0.0 to 0.7)

No statistical analyses for this end point

Primary: Percentage of Subjects With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[44]

End point description

Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination. -99999, 99999 indicated lower and upper limit of 95% CI could not be estimated, due to insufficient subjects with event.

End point type

Primary

End point timeframe

Within 30 minutes after Vaccination 1

Notes
[44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (confidence interval 95%)	0 (-99999 to 99999)	0 (-99999 to 99999)

No statistical analyses for this end point

Primary: Percentage of Subjects who Missed Days of School or Work due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects who Missed Days of School or Work due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[45]

End point description

An AE was any untoward medical occurrence in a subject, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Percentage of subjects who missed days of school or work due to AEs during vaccination phase were reported in this endpoint. Safety population included all randomised subjects who received at least 1 dose of investigational product and had safety data reported after vaccination.

End point type

Primary

End point timeframe

From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2

Notes
[45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1763	649
Units: Percentage of subjects
number (not applicable)	5.0	4.5

No statistical analyses for this end point

Primary: Percentage of Subjects With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

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End point title

Percentage of Subjects With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) ^[46]

End point description

End point type

Primary

End point timeframe

Within 30 minutes after Vaccination 2

Notes
[46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	Groups 1+3+5+7 Combined MenABCWY + Saline	Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Number of subjects analysed	1558	562
Units: Percentage of subjects
number (confidence interval 95%)	0 (-99999 to 99999)	0 (-99999 to 99999)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving At least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2

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End point title

Percentage of Subjects Achieving At least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2 ^[47]

End point description

4-fold increase was defined as: for subjects with baseline hSBA titer below LOD (or hSBA titer <1:4),response=hSBA titer >=1:16;baseline hSBA titer >=LOD (ie, hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), response=hSBA titer >=4times LLOQ; baseline hSBA titer >=LLOQ, response=hSBA titer >=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. PV1 evaluable immunogenicity population: subjects randomised to study group of interest; eligible at V 2; received vaccine at V1;blood drawn for assay testing at protocol-specified time points; at least 1 valid, determinate MenACWY assay result at V2; received no prohibited vaccines/treatment and had; no protocol deviations through V2. N=subjects evaluable for this endpoint. n=subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

1 month after Vaccination 1

Notes
[47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for specified reporting arms.

End point values	ACWY-Naive: Group 1 MenABCWY + Saline	ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM
Number of subjects analysed	501	254
Units: Percentage of subjects
number (confidence interval 95%)
MenA (n=499, 254)	97.0 (95.1 to 98.3)	95.3 (91.9 to 97.5)
MenC (n=501, 252)	62.9 (58.5 to 67.1)	52.4 (46.0 to 58.7)
MenW (n=492, 244)	79.3 (75.4 to 82.8)	73.0 (66.9 to 78.4)
MenY (n=494, 248)	82.0 (78.3 to 85.3)	70.6 (64.5 to 76.2)

MenA (Group 1 Vs Group 2)

Comparison groups

ACWY-Naive: Group 1 MenABCWY + Saline v ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

755

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[48]

Method

Parameter type

Difference in percentage

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

5.3

Notes
[48] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenC (Group 1 Vs Group 2)

Comparison groups

ACWY-Naive: Group 1 MenABCWY + Saline v ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

755

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[49]

Method

Parameter type

Difference in percentage

Point estimate

10.5

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

17.9

Notes
[49] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenW (Group 1 Vs Group 2)

Comparison groups

ACWY-Naive: Group 1 MenABCWY + Saline v ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

755

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[50]

Method

Parameter type

Difference in percentage

Point estimate

6.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

13.1

Notes
[50] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenY (Group 1 Vs Group 2)

Comparison groups

ACWY-Naive: Group 1 MenABCWY + Saline v ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

755

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[51]

Method

Parameter type

Difference in percentage

Point estimate

11.4

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

18.2

Notes
[51] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

Secondary: Percentage of Subjects Achieving At least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month after Vaccination 1 in Group 3 Compared to Group 4

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End point title

Percentage of Subjects Achieving At least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month after Vaccination 1 in Group 3 Compared to Group 4 ^[52]

End point description

4-fold increase was defined as: for subjects with baseline hSBA titer below LOD (or hSBA titer <1:4),response=hSBA titer >=1:16;baseline hSBA titer >=LOD (ie, hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), response=hSBA titer >=4times LLOQ; baseline hSBA titer >=LLOQ, response=hSBA titer >=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. PV1 evaluable immunogenicity population: subjects randomised to study group of interest; eligible at V 2; received vaccine at V1;blood drawn for assay testing at protocol-specified time points; at least 1 valid, determinate MenACWY assay result at V2; received no prohibited vaccines/treatment and had; no protocol deviations through V2. N=subjects evaluable for this endpoint. n=subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

1 month after Vaccination 1

Notes
[52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for specified reporting arms.

End point values	ACWY-Experienced: Group 3 MenABCWY + Saline	ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM
Number of subjects analysed	442	227
Units: Percentage of subjects
number (confidence interval 95%)
MenA (n=439, 227)	94.8 (92.2 to 96.7)	96.9 (93.7 to 98.8)
MenC (n=439, 226)	93.4 (90.7 to 95.5)	94.7 (90.9 to 97.2)
MenW (n=428, 222)	97.4 (95.4 to 98.7)	96.4 (93.0 to 98.4)
MenY (n=442, 223)	94.3 (91.8 to 96.3)	93.7 (89.7 to 96.5)

MenA (Group 3 Vs Group 4)

Comparison groups

ACWY-Experienced: Group 3 MenABCWY + Saline v ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

669

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[53]

Method

Parameter type

Difference in percentage

Point estimate

-2.2

Confidence interval

level

95%

sides

2-sided

lower limit

-5.2

upper limit

1.4

Notes
[53] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenC (Group 3 Vs Group 4)

Comparison groups

ACWY-Experienced: Group 3 MenABCWY + Saline v ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

669

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[54]

Method

Parameter type

Difference in percentage

Point estimate

-1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

2.9

Notes
[54] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenW (Group 3 Vs Group 4)

Comparison groups

ACWY-Experienced: Group 3 MenABCWY + Saline v ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

669

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[55]

Method

Parameter type

Difference in percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

4.6

Notes
[55] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

MenY (Group 3 Vs Group 4)

Comparison groups

ACWY-Experienced: Group 3 MenABCWY + Saline v ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Number of subjects included in analysis

669

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[56]

Method

Parameter type

Difference in percentage

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

Notes
[56] - 95% CI for the difference in percentage of subjects was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of subjects was > -10%, the non-inferiority was concluded.

Adverse events

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Timeframe for reporting adverse events

Systematic assessment(SA): local reactions/systemic events recorded within 7 days after vaccination 1, 2; Non-SA: SAEs recorded from Day 1 up to 6 months after vaccination 2 and other AEs recorded from Day 1 up to 1 month after vaccination 2

Adverse event reporting additional description

Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorised as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event. Safety population was evaluated.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

ACWY-Naive: Group 1 MenABCWY + Saline

Reporting group description

On Day 1, Neisseria meningitidis group A, C, W, and Y (ACWY) naive subjects received a single dose of 0.5 milliliter (mL) Neisseria meningitidis serogroup A,B,C,W,Y (MenABCWY) intramuscularly into the left deltoid along with 0.5 mL of saline intramuscularly into the right deltoid (Vaccination 1). After 6 months, subjects received 0.5 mL of MenABCWY intramuscularly into the left deltoid (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Reporting group title

ACWY-Experienced: Group 3 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM

Reporting group description

On Day 1, ACWY naive subjects received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid along with 0.5 mL of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria conjugate vaccine (MenACWY-CRM) intramuscularly into the right deltoid (Vaccination 1). After 6 months, subjects received 0.5 mL of Trumenba intramuscularly into the left deltoid (Vaccination 2). Subjects were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses.

Reporting group title

ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Naive: Group 5 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM

Reporting group description

Reporting group title

ACWY-Experienced: Group 7 MenABCWY + Saline

Reporting group description

Reporting group title

ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM

Reporting group description

Serious adverse events	ACWY-Naive: Group 1 MenABCWY + Saline	ACWY-Experienced: Group 3 MenABCWY + Saline	ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM	ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM	ACWY-Naive: Group 5 MenABCWY + Saline	ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM	ACWY-Experienced: Group 7 MenABCWY + Saline	ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 547 (1.10%)	3 / 526 (0.57%)	1 / 274 (0.36%)	2 / 260 (0.77%)	2 / 537 (0.37%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Head injury
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Overdose
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spinal cord injury
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	1 / 537 (0.19%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	1 / 537 (0.19%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Postural orthostatic tachycardia syndrome
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Status migrainosus
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	1 / 260 (0.38%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Anxiety
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Depression
subjects affected / exposed	2 / 547 (0.37%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Depression suicidal
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Disruptive mood dysregulation disorder
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	1 / 274 (0.36%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	1 / 260 (0.38%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Food intolerance
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	ACWY-Naive: Group 1 MenABCWY + Saline	ACWY-Experienced: Group 3 MenABCWY + Saline	ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM	ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM	ACWY-Naive: Group 5 MenABCWY + Saline	ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM	ACWY-Experienced: Group 7 MenABCWY + Saline	ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM
Total subjects affected by non serious adverse events
subjects affected / exposed	533 / 547 (97.44%)	504 / 526 (95.82%)	262 / 274 (95.62%)	244 / 260 (93.85%)	512 / 537 (95.34%)	53 / 56 (94.64%)	148 / 153 (96.73%)	58 / 59 (98.31%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
subjects affected / exposed	1 / 547 (0.18%)	1 / 526 (0.19%)	1 / 274 (0.36%)	1 / 260 (0.38%)	2 / 537 (0.37%)	0 / 56 (0.00%)	2 / 153 (1.31%)	1 / 59 (1.69%)
occurrences all number	1	1	1	1	2	0	2	1
General disorders and administration site conditions
Chills (CHILLS)
alternative assessment type: Systematic
subjects affected / exposed	155 / 547 (28.34%)	151 / 526 (28.71%)	78 / 274 (28.47%)	59 / 260 (22.69%)	130 / 537 (24.21%)	14 / 56 (25.00%)	43 / 153 (28.10%)	19 / 59 (32.20%)
occurrences all number	196	214	113	83	176	17	61	24
Fatigue
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	0 / 274 (0.00%)	0 / 260 (0.00%)	2 / 537 (0.37%)	0 / 56 (0.00%)	0 / 153 (0.00%)	1 / 59 (1.69%)
occurrences all number	0	1	0	0	2	0	0	1
Fatigue (FATIGUE)
alternative assessment type: Systematic
subjects affected / exposed	364 / 547 (66.54%)	337 / 526 (64.07%)	183 / 274 (66.79%)	160 / 260 (61.54%)	317 / 537 (59.03%)	30 / 56 (53.57%)	99 / 153 (64.71%)	43 / 59 (72.88%)
occurrences all number	621	628	314	278	521	48	165	69
Injection site pain (PAIN AT INJECTION SITE)
alternative assessment type: Systematic
subjects affected / exposed	522 / 547 (95.43%)	486 / 526 (92.40%)	247 / 274 (90.15%)	228 / 260 (87.69%)	493 / 537 (91.81%)	51 / 56 (91.07%)	144 / 153 (94.12%)	57 / 59 (96.61%)
occurrences all number	946	860	455	387	889	82	245	99
Pyrexia
subjects affected / exposed	2 / 547 (0.37%)	2 / 526 (0.38%)	0 / 274 (0.00%)	0 / 260 (0.00%)	4 / 537 (0.74%)	0 / 56 (0.00%)	1 / 153 (0.65%)	1 / 59 (1.69%)
occurrences all number	2	2	0	0	5	0	1	1
Pyrexia (FEVER)
alternative assessment type: Systematic
subjects affected / exposed	44 / 547 (8.04%)	29 / 526 (5.51%)	24 / 274 (8.76%)	13 / 260 (5.00%)	42 / 537 (7.82%)	3 / 56 (5.36%)	8 / 153 (5.23%)	3 / 59 (5.08%)
occurrences all number	50	32	24	14	47	3	8	4
Swelling (SWELLING)
alternative assessment type: Systematic
subjects affected / exposed	186 / 547 (34.00%)	158 / 526 (30.04%)	71 / 274 (25.91%)	57 / 260 (21.92%)	200 / 537 (37.24%)	16 / 56 (28.57%)	49 / 153 (32.03%)	19 / 59 (32.20%)
occurrences all number	271	211	100	76	289	22	64	27
Reproductive system and breast disorders
Amenorrhoea
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	0	1	0	0	0	0	2	0
Dysmenorrhoea
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	1 / 274 (0.36%)	1 / 260 (0.38%)	1 / 537 (0.19%)	0 / 56 (0.00%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	0	1	1	1	1	0	2	0
Heavy menstrual bleeding
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	1 / 260 (0.38%)	0 / 537 (0.00%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 547 (0.18%)	6 / 526 (1.14%)	0 / 274 (0.00%)	0 / 260 (0.00%)	2 / 537 (0.37%)	0 / 56 (0.00%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	1	7	0	0	2	0	2	0
Painful respiration
subjects affected / exposed	0 / 547 (0.00%)	2 / 526 (0.38%)	0 / 274 (0.00%)	1 / 260 (0.38%)	1 / 537 (0.19%)	0 / 56 (0.00%)	0 / 153 (0.00%)	1 / 59 (1.69%)
occurrences all number	0	2	0	1	1	0	0	1
Rhinitis allergic
subjects affected / exposed	3 / 547 (0.55%)	3 / 526 (0.57%)	2 / 274 (0.73%)	2 / 260 (0.77%)	3 / 537 (0.56%)	0 / 56 (0.00%)	4 / 153 (2.61%)	0 / 59 (0.00%)
occurrences all number	3	3	2	2	3	0	5	0
Psychiatric disorders
Anxiety
subjects affected / exposed	3 / 547 (0.55%)	1 / 526 (0.19%)	1 / 274 (0.36%)	2 / 260 (0.77%)	1 / 537 (0.19%)	1 / 56 (1.79%)	1 / 153 (0.65%)	0 / 59 (0.00%)
occurrences all number	3	1	1	2	1	1	1	0
Major depression
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	0 / 274 (0.00%)	1 / 260 (0.38%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	1 / 59 (1.69%)
occurrences all number	0	1	0	1	0	0	0	1
Investigations
SARS-CoV-2 test positive
subjects affected / exposed	4 / 547 (0.73%)	8 / 526 (1.52%)	2 / 274 (0.73%)	3 / 260 (1.15%)	4 / 537 (0.74%)	0 / 56 (0.00%)	1 / 153 (0.65%)	1 / 59 (1.69%)
occurrences all number	4	8	2	3	4	0	1	1
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	2 / 547 (0.37%)	6 / 526 (1.14%)	1 / 274 (0.36%)	0 / 260 (0.00%)	3 / 537 (0.56%)	1 / 56 (1.79%)	1 / 153 (0.65%)	0 / 59 (0.00%)
occurrences all number	2	6	1	0	5	1	1	0
Fall
subjects affected / exposed	6 / 547 (1.10%)	5 / 526 (0.95%)	2 / 274 (0.73%)	4 / 260 (1.54%)	6 / 537 (1.12%)	1 / 56 (1.79%)	1 / 153 (0.65%)	0 / 59 (0.00%)
occurrences all number	6	5	2	4	6	1	1	0
Head injury
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	1 / 537 (0.19%)	0 / 56 (0.00%)	2 / 153 (1.31%)	1 / 59 (1.69%)
occurrences all number	0	0	0	0	1	0	2	1
Joint injury
subjects affected / exposed	1 / 547 (0.18%)	1 / 526 (0.19%)	0 / 274 (0.00%)	1 / 260 (0.38%)	1 / 537 (0.19%)	0 / 56 (0.00%)	0 / 153 (0.00%)	1 / 59 (1.69%)
occurrences all number	1	1	0	1	1	0	0	1
Ligament sprain
subjects affected / exposed	2 / 547 (0.37%)	0 / 526 (0.00%)	2 / 274 (0.73%)	0 / 260 (0.00%)	1 / 537 (0.19%)	1 / 56 (1.79%)	1 / 153 (0.65%)	0 / 59 (0.00%)
occurrences all number	3	0	2	0	1	1	1	0
Radius fracture
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	1 / 274 (0.36%)	0 / 260 (0.00%)	0 / 537 (0.00%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	1	0	1	0	0	1	0	0
Skin laceration
subjects affected / exposed	6 / 547 (1.10%)	1 / 526 (0.19%)	0 / 274 (0.00%)	1 / 260 (0.38%)	1 / 537 (0.19%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	6	1	0	1	1	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	1 / 547 (0.18%)	1 / 526 (0.19%)	0 / 274 (0.00%)	3 / 260 (1.15%)	3 / 537 (0.56%)	0 / 56 (0.00%)	2 / 153 (1.31%)	1 / 59 (1.69%)
occurrences all number	1	1	0	3	3	0	2	1
Headache (HEADACHE)
alternative assessment type: Systematic
subjects affected / exposed	330 / 547 (60.33%)	312 / 526 (59.32%)	152 / 274 (55.47%)	161 / 260 (61.92%)	282 / 537 (52.51%)	24 / 56 (42.86%)	86 / 153 (56.21%)	37 / 59 (62.71%)
occurrences all number	553	571	255	264	467	34	145	63
Migraine
subjects affected / exposed	1 / 547 (0.18%)	1 / 526 (0.19%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	3 / 153 (1.96%)	0 / 59 (0.00%)
occurrences all number	1	1	0	0	0	0	3	0
Ear and labyrinth disorders
Cerumen impaction
subjects affected / exposed	2 / 547 (0.37%)	4 / 526 (0.76%)	1 / 274 (0.36%)	2 / 260 (0.77%)	2 / 537 (0.37%)	0 / 56 (0.00%)	1 / 153 (0.65%)	2 / 59 (3.39%)
occurrences all number	2	4	1	2	2	0	1	2
Ear pain
subjects affected / exposed	0 / 547 (0.00%)	3 / 526 (0.57%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	0	3	0	0	0	1	0	0
Eye disorders
Conjunctivitis allergic
subjects affected / exposed	0 / 547 (0.00%)	2 / 526 (0.38%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	0	2	0	0	0	0	2	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	2 / 547 (0.37%)	5 / 526 (0.95%)	0 / 274 (0.00%)	1 / 260 (0.38%)	2 / 537 (0.37%)	1 / 56 (1.79%)	0 / 153 (0.00%)	1 / 59 (1.69%)
occurrences all number	2	6	0	1	3	1	0	1
Abdominal pain lower
subjects affected / exposed	0 / 547 (0.00%)	2 / 526 (0.38%)	0 / 274 (0.00%)	0 / 260 (0.00%)	1 / 537 (0.19%)	0 / 56 (0.00%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	0	2	0	0	1	0	2	0
Constipation
subjects affected / exposed	2 / 547 (0.37%)	1 / 526 (0.19%)	0 / 274 (0.00%)	0 / 260 (0.00%)	6 / 537 (1.12%)	0 / 56 (0.00%)	3 / 153 (1.96%)	0 / 59 (0.00%)
occurrences all number	2	1	0	0	7	0	3	0
Diarrhoea (DIARRHEA)
alternative assessment type: Systematic
subjects affected / exposed	69 / 547 (12.61%)	116 / 526 (22.05%)	50 / 274 (18.25%)	54 / 260 (20.77%)	72 / 537 (13.41%)	8 / 56 (14.29%)	23 / 153 (15.03%)	8 / 59 (13.56%)
occurrences all number	82	146	60	67	104	10	29	9
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	0 / 274 (0.00%)	0 / 260 (0.00%)	1 / 537 (0.19%)	0 / 56 (0.00%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	0	1	0	0	1	0	2	0
Nausea
subjects affected / exposed	3 / 547 (0.55%)	2 / 526 (0.38%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	3 / 153 (1.96%)	0 / 59 (0.00%)
occurrences all number	3	2	0	0	0	0	3	0
Vomiting (VOMITING)
alternative assessment type: Systematic
subjects affected / exposed	23 / 547 (4.20%)	22 / 526 (4.18%)	13 / 274 (4.74%)	4 / 260 (1.54%)	21 / 537 (3.91%)	3 / 56 (5.36%)	5 / 153 (3.27%)	3 / 59 (5.08%)
occurrences all number	25	26	15	4	24	3	5	3
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 547 (0.00%)	5 / 526 (0.95%)	1 / 274 (0.36%)	3 / 260 (1.15%)	8 / 537 (1.49%)	0 / 56 (0.00%)	1 / 153 (0.65%)	0 / 59 (0.00%)
occurrences all number	0	5	1	3	8	0	1	0
Alopecia areata
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	1 / 274 (0.36%)	0 / 260 (0.00%)	0 / 537 (0.00%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0
Dermatitis atopic
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	1 / 274 (0.36%)	0 / 260 (0.00%)	2 / 537 (0.37%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	1	0	1	0	2	1	0	0
Erythema (REDNESS)
alternative assessment type: Systematic
subjects affected / exposed	183 / 547 (33.46%)	162 / 526 (30.80%)	75 / 274 (27.37%)	58 / 260 (22.31%)	190 / 537 (35.38%)	15 / 56 (26.79%)	39 / 153 (25.49%)	16 / 59 (27.12%)
occurrences all number	276	211	105	66	289	21	60	25
Keratosis pilaris
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 547 (0.18%)	4 / 526 (0.76%)	2 / 274 (0.73%)	1 / 260 (0.38%)	1 / 537 (0.19%)	0 / 56 (0.00%)	2 / 153 (1.31%)	2 / 59 (3.39%)
occurrences all number	1	4	2	1	1	0	2	2
Arthralgia (JOINT PAIN)
alternative assessment type: Systematic
subjects affected / exposed	156 / 547 (28.52%)	156 / 526 (29.66%)	75 / 274 (27.37%)	83 / 260 (31.92%)	144 / 537 (26.82%)	12 / 56 (21.43%)	48 / 153 (31.37%)	19 / 59 (32.20%)
occurrences all number	205	224	104	112	180	17	67	24
Costochondritis
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	1 / 537 (0.19%)	0 / 56 (0.00%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	1	0	0	0	1	0	2	0
Myalgia
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	1 / 59 (1.69%)
occurrences all number	0	0	0	0	0	0	0	2
Myalgia (MUSCLE PAIN)
alternative assessment type: Systematic
subjects affected / exposed	198 / 547 (36.20%)	207 / 526 (39.35%)	97 / 274 (35.40%)	97 / 260 (37.31%)	167 / 537 (31.10%)	18 / 56 (32.14%)	57 / 153 (37.25%)	22 / 59 (37.29%)
occurrences all number	272	282	138	139	215	25	79	30
Infections and infestations
Acute sinusitis
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	0 / 274 (0.00%)	2 / 260 (0.77%)	1 / 537 (0.19%)	1 / 56 (1.79%)	1 / 153 (0.65%)	0 / 59 (0.00%)
occurrences all number	0	1	0	2	1	1	1	0
COVID-19
subjects affected / exposed	22 / 547 (4.02%)	24 / 526 (4.56%)	12 / 274 (4.38%)	12 / 260 (4.62%)	36 / 537 (6.70%)	3 / 56 (5.36%)	10 / 153 (6.54%)	0 / 59 (0.00%)
occurrences all number	22	24	12	12	36	3	10	0
Conjunctivitis
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	1 / 537 (0.19%)	1 / 56 (1.79%)	1 / 153 (0.65%)	0 / 59 (0.00%)
occurrences all number	0	0	0	0	1	1	1	0
Cytomegalovirus infection
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Gastroenteritis
subjects affected / exposed	2 / 547 (0.37%)	1 / 526 (0.19%)	1 / 274 (0.36%)	0 / 260 (0.00%)	2 / 537 (0.37%)	0 / 56 (0.00%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	2	1	1	0	2	0	2	0
Impetigo
subjects affected / exposed	0 / 547 (0.00%)	1 / 526 (0.19%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0
Influenza
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	0 / 274 (0.00%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	3 / 153 (1.96%)	0 / 59 (0.00%)
occurrences all number	1	0	0	0	0	0	3	0
Nasopharyngitis
subjects affected / exposed	3 / 547 (0.55%)	1 / 526 (0.19%)	6 / 274 (2.19%)	1 / 260 (0.38%)	0 / 537 (0.00%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	3	1	7	1	0	0	0	0
Lice infestation
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	1 / 274 (0.36%)	0 / 260 (0.00%)	1 / 537 (0.19%)	1 / 56 (1.79%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	0	0	1	0	1	1	0	0
Otitis externa
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	2 / 274 (0.73%)	1 / 260 (0.38%)	1 / 537 (0.19%)	0 / 56 (0.00%)	0 / 153 (0.00%)	1 / 59 (1.69%)
occurrences all number	1	0	2	1	1	0	0	1
Otitis media
subjects affected / exposed	0 / 547 (0.00%)	4 / 526 (0.76%)	2 / 274 (0.73%)	1 / 260 (0.38%)	3 / 537 (0.56%)	0 / 56 (0.00%)	1 / 153 (0.65%)	1 / 59 (1.69%)
occurrences all number	0	5	2	1	3	0	1	1
Pharyngitis
subjects affected / exposed	5 / 547 (0.91%)	10 / 526 (1.90%)	4 / 274 (1.46%)	2 / 260 (0.77%)	10 / 537 (1.86%)	2 / 56 (3.57%)	7 / 153 (4.58%)	1 / 59 (1.69%)
occurrences all number	5	11	5	2	13	2	9	1
Pharyngitis streptococcal
subjects affected / exposed	0 / 547 (0.00%)	0 / 526 (0.00%)	0 / 274 (0.00%)	2 / 260 (0.77%)	3 / 537 (0.56%)	1 / 56 (1.79%)	2 / 153 (1.31%)	1 / 59 (1.69%)
occurrences all number	0	0	0	2	3	1	2	1
Respiratory tract infection viral
subjects affected / exposed	3 / 547 (0.55%)	1 / 526 (0.19%)	0 / 274 (0.00%)	1 / 260 (0.38%)	1 / 537 (0.19%)	1 / 56 (1.79%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	3	1	0	1	1	1	2	0
Sinusitis
subjects affected / exposed	0 / 547 (0.00%)	3 / 526 (0.57%)	2 / 274 (0.73%)	0 / 260 (0.00%)	0 / 537 (0.00%)	0 / 56 (0.00%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	0	3	2	0	0	0	2	0
Tonsillitis
subjects affected / exposed	5 / 547 (0.91%)	4 / 526 (0.76%)	4 / 274 (1.46%)	0 / 260 (0.00%)	6 / 537 (1.12%)	0 / 56 (0.00%)	1 / 153 (0.65%)	0 / 59 (0.00%)
occurrences all number	5	5	5	0	6	0	1	0
Upper respiratory tract infection
subjects affected / exposed	10 / 547 (1.83%)	17 / 526 (3.23%)	7 / 274 (2.55%)	7 / 260 (2.69%)	11 / 537 (2.05%)	4 / 56 (7.14%)	7 / 153 (4.58%)	1 / 59 (1.69%)
occurrences all number	10	17	7	7	12	6	8	1
Viral infection
subjects affected / exposed	1 / 547 (0.18%)	0 / 526 (0.00%)	2 / 274 (0.73%)	3 / 260 (1.15%)	3 / 537 (0.56%)	0 / 56 (0.00%)	0 / 153 (0.00%)	0 / 59 (0.00%)
occurrences all number	1	0	3	3	5	0	0	0
Viral upper respiratory tract infection
subjects affected / exposed	3 / 547 (0.55%)	1 / 526 (0.19%)	2 / 274 (0.73%)	0 / 260 (0.00%)	3 / 537 (0.56%)	0 / 56 (0.00%)	2 / 153 (1.31%)	0 / 59 (0.00%)
occurrences all number	3	1	2	0	3	0	2	0

More information

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Were there any global substantial amendments to the protocol? Yes

30 Apr 2021

1) Protocol Sections 1.2, 1.3, 4.1, 8, 8.1.1, and 8.10.1.4: Added an optional increase in the volume of the blood draws at Visit 4 for the immunogenicity subset from 25 to 50 mL, to support assay development. The volume of blood drawn will depend on the consent obtained. 2) Throughout the protocol: The term “clinical trial (CT) SAE Report Form” has been replaced with “Vaccine SAE Reporting Form,” as per the protocol administrative change letter (PACL) dated 08 May 2020. 3) Protocol Section 10.4.3, Woman of Childbearing Potential (WOCBP): The definition of postmenopausal state has been amended, as per the PACL dated 08 October 2020.

13 Jun 2022

1) Protocol Sections 5.2.1.1, 6.5.1, and 6.5.2: Made allowance for coronavirus disease 2019 (COVID-19) vaccinations within 8 days of study vaccination instead of 14 days (per the protocol administrative change letter [PACL] dated 01 July 2021).

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 3, Randomized, Active-Controlled, Observer-Blinded Trial To Assess The Safety, Tolerability, And Immunogenicity Of MenABCWY In Healthy Participants >=10 To <26 Years Of Age

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects Achieving At least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2

Primary: Percentage of Subjects Achieving At least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2

Primary: Percentage of Subjects Achieving At least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4

Primary: Percentage of Subjects Achieving At least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4

Primary: Percentage of Subjects Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for all Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined

Primary: Percentage of Subjects Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for all Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined

Primary: Percentage of Subjects Achieving At least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined

Primary: Percentage of Subjects Achieving At least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects who Missed Days of School or Work due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects who Missed Days of School or Work due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Primary: Percentage of Subjects With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)

Clinical Trial Results:
A Phase 3, Randomized, Active-Controlled, Observer-Blinded Trial To Assess The Safety, Tolerability, And Immunogenicity Of MenABCWY In Healthy Participants >=10 To <26 Years Of Age