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Clinical Trial Results:
A Phase III, Randomised, Open, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity and Persistence of 1 and 2 Doses of Meningococcal Conjugate Vaccine MenACWY-TT in Toddlers (After 1 Month and up to 5 Years) and to Demonstrate Noninferiority of Co-Administration of MenACWY-TT and 13-Valent Pneumococcal Conjugate Vaccine Prevenar 13® Versus Separate Administration of the 2 Vaccines.

Summary
EudraCT number	2013-001083-28
Trial protocol	CZ
Global end of trial date	05 Dec 2019

Results information
Results version number	v1(current)
This version publication date	25 Sep 2021
First version publication date	25 Sep 2021
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

MENACWY-TT-104

ISRCTN number

US NCT number

NCT01939158

WHO universal trial number (UTN)

Other trial identifiers

C0921003: 116892

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

16 Aug 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

05 Dec 2019

Was the trial ended prematurely?

Main objective of the trial

To evaluate the immunogenicity of MenACWY-TT after administration of 1 dose in vaccine groups ACWY1d and ACWY2d or 2 doses in vaccine group ACWY2d with respect to serum bactericidal assay using rabbit complement to measure activity against Neisseria meningitidis groups A, C, W-135, and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY) titers. To evaluate the long-term persistence of the immune response induced by 1 or 2 doses of MenACWY-TT with respect to rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers.

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 Harmonization (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

02 Oct 2013

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy, Safety

Long term follow-up duration

5 Years

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Czechia: 206

Country: Number of subjects enrolled

Panama: 29

Country: Number of subjects enrolled

South Africa: 204

Country: Number of subjects enrolled

Turkey: 59

Country: Number of subjects enrolled

Australia: 167

Country: Number of subjects enrolled

Canada: 137

Worldwide total number of subjects

802

EEA total number of subjects

206

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)

802

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Study was conducted from 2 October 2013 to 5 December 2019.

Screening details

A total of 803 subjects were enrolled and were randomised in 1:1:1:1 ratio to either ACWY1d, ACWY2d, Co-ad and PCV13 groups. Of these, 1 subject was randomised but did not receive the study vaccine.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

ACWY1d Group

Arm description

Subjects received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.

Arm type

Experimental

Investigational medicinal product name

MenACWY-TT vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received single dose of MenACWY-TT vaccine administered intramuscularly at Month 0.

ACWY2d Group

Arm description

Subjects received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.

Arm type

Experimental

Investigational medicinal product name

MenACWY-TT vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.

Co-ad Group

Arm description

Subjects received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.

Arm type

Experimental

Investigational medicinal product name

MenACWY-TT vaccine, Prevnar 13

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.

PCV13 Group

Arm description

Subjects received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.

Arm type

Experimental

Investigational medicinal product name

Prevnar 13, MenACWY-TT vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.

Number of subjects in period 1	ACWY1d Group	ACWY2d Group	Co-ad Group	PCV13 Group
Started	203	197	201	201
Completed	156	146	160	157
Not completed	47	51	41	44
Adverse event, serious fatal	-	-	1	1
Consent withdrawn by subject	22	24	15	17
Adverse event, non-fatal	1	-	-	-
No longer meets eligibility criteria	-	-	1	-
Migrated/moved from study area	5	7	3	6
Unspecified	1	3	4	3
Lost to follow-up	18	17	17	17

Baseline characteristics

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Reporting group title

ACWY1d Group

Reporting group description

Subjects received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.

Reporting group title

ACWY2d Group

Reporting group description

Subjects received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.

Reporting group title

Co-ad Group

Reporting group description

Subjects received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.

Reporting group title

PCV13 Group

Reporting group description

Subjects received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.

Reporting group values	ACWY1d Group	ACWY2d Group	Co-ad Group	PCV13 Group	Total
Number of subjects	203	197	201	201	802
Age categorical
Units: Subjects
In utero	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0
Infants and toddlers (28 days-23 months)	203	197	201	201	802
Children (2-11 years)	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0
Adults (18-64 years)	0	0	0	0	0
From 65-84 years	0	0	0	0	0
85 years and over	0	0	0	0	0
Age Continuous
Units: months
arithmetic mean (standard deviation)	12.8 ( 0.9 )	12.8 ( 0.9 )	12.8 ( 0.9 )	12.7 ( 0.9 )	-
Sex: Female, Male
Units: Subjects
Female	94	85	98	98	375
Male	109	112	103	103	427
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	8	8	7	8	31
Not Hispanic or Latino	195	189	194	193	771
Unknown or Not Reported	0	0	0	0	0
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	1	0	1
Asian	1	3	2	3	9
Native Hawaiian or Other Pacific Islander	0	0	1	1	2
Black or African American	33	33	31	30	127
White	135	127	137	134	533
More than one race	34	34	29	33	130
Unknown or Not Reported	0	0	0	0	0

End points

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Reporting group title

ACWY1d Group

Reporting group description

Subjects received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.

Reporting group title

ACWY2d Group

Reporting group description

Subjects received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.

Reporting group title

Co-ad Group

Reporting group description

Subjects received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.

Reporting group title

PCV13 Group

Reporting group description

Subjects received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.

Primary: Percentage of Subjects With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups

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End point title

Percentage of Subjects With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups ^[1] ^[2]

End point description

Serogroups:Neisseria meningitidis serogroup A (MenA),Neisseria meningitidis serogroup C (MenC),Neisseria meningitidis serogroup W-135 (MenW-135),Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with rSBA titers >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1:subjects who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures, intervals in protocol, did not present with medical condition or received product leading to exclusion or non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at previous time point. "Number of Subjects Analysed"=subjects evaluable for this endpoint and ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for PCV13 group.

End point type

Primary

End point timeframe

1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

Notes
[1] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.
[2] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group	Co-ad Group
Number of subjects analysed	180	158	178
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA (n=180, 158, 178)	97.8 (94.4 to 99.4)	96.8 (92.8 to 99.0)	94.9 (90.6 to 97.7)
rSBA-MenC (n=179, 157, 176)	95.0 (90.7 to 97.7)	95.5 (91.0 to 98.2)	96.0 (92.0 to 98.4)
rSBA-MenW-135 (n=180, 158, 177)	95.0 (90.7 to 97.7)	94.9 (90.3 to 97.8)	93.2 (88.5 to 96.4)
rSBA-MenY (n=180, 157, 177)	92.8 (88.0 to 96.1)	93.6 (88.6 to 96.9)	89.8 (84.4 to 93.9)

No statistical analyses for this end point

Primary: Percentage of Subjects With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

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End point title

Percentage of Subjects With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group ^[3] ^[4]

End point description

Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with rSBA titers >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. Here "number of subjects analysed" signifies subjects evaluable for this endpoint. Data for this endpoint was not planned to be collected and analysed for ACWY1d, Co-ad and PCV13 reporting groups.

End point type

Primary

End point timeframe

1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

Notes
[3] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.
[4] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY2d Group
Number of subjects analysed	150
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA	98.0 (94.3 to 99.6)
rSBA-MenC	98.7 (95.3 to 99.8)
rSBA-MenW-135	100.0 (97.6 to 100.0)
rSBA-MenY	99.3 (96.3 to 100.0)

No statistical analyses for this end point

Primary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups

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End point title

Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups ^[5] ^[6]

End point description

Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. Here "number of subjects analysed" signifies subjects evaluable for this endpoint. Data for this endpoint was not planned to be collected and analysed for Co-ad and PCV13 reporting groups.

End point type

Primary

End point timeframe

At Year 1

Notes
[5] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.
[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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group
Number of subjects analysed	167	143
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA: >=1:8	63.5 (55.7 to 70.8)	70.6 (62.4 to 77.9)
rSBA-MenC: >=1:8	49.1 (41.3 to 56.9)	55.2 (46.7 to 63.6)
rSBA-MenW-135: >=1:8	65.3 (57.5 to 72.5)	77.6 (69.9 to 84.2)
rSBA-MenY: >=1:8	73.1 (65.7 to 79.6)	79.7 (72.2 to 86.0)
rSBA-MenA: >=1:128	44.9 (37.2 to 52.8)	50.3 (41.9 to 58.8)
rSBA-MenC: >=1:128	21.0 (15.1 to 27.9)	27.3 (20.2 to 35.3)
rSBA-MenW-135: >=1:128	46.7 (39.0 to 54.6)	60.1 (51.6 to 68.2)
rSBA-MenY: >=1:128	52.1 (44.2 to 59.9)	60.8 (52.3 to 68.9)

No statistical analyses for this end point

Primary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups

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End point title

Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups ^[7] ^[8]

End point description

GMTs of antibodies against each serogroup were assessed using rSBA. Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. Here "number of subjects analysed" signifies subjects evaluable for this endpoint. Data for this endpoint was not planned to be collected and analysed for Co-ad and PCV13 reporting groups.

End point type

Primary

End point timeframe

At Year 1

Notes
[7] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.
[8] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group
Number of subjects analysed	167	143
Units: titers (1/dilution)
geometric mean (confidence interval 95%)
rSBA-MenA	62.7 (42.6 to 92.2)	76.6 (50.7 to 115.7)
rSBA-MenC	16.2 (12.4 to 21.1)	21.2 (15.6 to 28.9)
rSBA-MenW-135	57.2 (39.9 to 82.0)	123.1 (82.7 to 183.4)
rSBA-MenY	76.8 (54.2 to 109.0)	112.3 (77.5 to 162.8)

No statistical analyses for this end point

Primary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups

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End point title

Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups ^[9] ^[10]

End point description

Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. Here "number of subjects analysed" signifies subjects evaluable for this endpoint. Data for this endpoint was not planned to be collected and analysed for Co-ad and PCV13 reporting groups.

End point type

Primary

End point timeframe

At Year 3

Notes
[9] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.
[10] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group
Number of subjects analysed	147	121
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA: >=1:8	46.9 (38.7 to 55.3)	54.5 (45.2 to 63.6)
rSBA-MenC: >=1:8	35.4 (27.7 to 43.7)	33.9 (25.5 to 43.0)
rSBA-MenW-135: >=1:8	59.2 (50.8 to 67.2)	72.7 (63.9 to 80.4)
rSBA-MenY: >=1:8	61.9 (53.5 to 69.8)	68.6 (59.5 to 76.7)
rSBA-MenA: >=1:128	34.0 (26.4 to 42.3)	31.4 (23.3 to 40.5)
rSBA-MenC: >=1:128	9.5 (5.3 to 15.5)	15.7 (9.7 to 23.4)
rSBA-MenW-135: >=1:128	42.9 (34.7 to 51.3)	52.9 (43.6 to 62.0)
rSBA-MenY: >=1:128	49.0 (40.7 to 57.3)	53.7 (44.4 to 62.8)

No statistical analyses for this end point

Primary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups

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End point title

Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups ^[11] ^[12]

End point description

GMTs of antibodies against each serogroup were assessed using rSBA. Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. Here "number of subjects analysed" signifies subjects evaluable for this endpoint. Data for this endpoint was not planned to be collected and analysed for Co-ad and PCV13 reporting groups.

End point type

Primary

End point timeframe

At Year 3

Notes
[11] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.
[12] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group
Number of subjects analysed	147	121
Units: titers (1/dilution)
geometric mean (confidence interval 95%)
rSBA-MenA	29.7 (19.8 to 44.5)	28.5 (18.7 to 43.6)
rSBA-MenC	9.8 (7.6 to 12.7)	11.5 (8.4 to 15.8)
rSBA-MenW-135	42.5 (29.2 to 61.8)	92.9 (59.9 to 143.9)
rSBA-MenY	58.0 (39.1 to 86.0)	75.1 (48.7 to 115.9)

No statistical analyses for this end point

Primary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups

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End point title

Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups ^[13] ^[14]

End point description

Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135), Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. "Number of subjects analysed"=subjects evaluable for this endpoint and ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for Co-ad and PCV13 groups.

End point type

Primary

End point timeframe

At Year 5

Notes
[13] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.
[14] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group
Number of subjects analysed	133	117
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA: >=1:8 (n=133, 117)	58.6 (49.8 to 67.1)	65.8 (56.5 to 74.3)
rSBA-MenC: >=1:8 (n=132, 116)	20.5 (13.9 to 28.3)	28.4 (20.5 to 37.6)
rSBA-MenW-135: >=1:8 (n=133, 117)	44.4 (35.8 to 53.2)	50.4 (41.0 to 59.8)
rSBA-MenY: >=1:8 (n=133, 117)	47.4 (38.7 to 56.2)	58.1 (48.6 to 67.2)
rSBA-MenA: >=1:128 (n=133, 117)	43.6 (35.0 to 52.5)	53.0 (43.5 to 62.3)
rSBA-MenC: >=1:128 (n=132, 116)	6.1 (2.7 to 11.6)	10.3 (5.5 to 17.4)
rSBA-MenW-135: >=1:128 (n=133, 117)	32.3 (24.5 to 41.0)	39.3 (30.4 to 48.8)
rSBA-MenY: >=1:128 (n=133, 117)	39.8 (31.5 to 48.7)	52.1 (42.7 to 61.5)

No statistical analyses for this end point

Primary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups

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End point title

Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups ^[15] ^[16]

End point description

GMTs of antibodies against each serogroup were assessed using rSBA. Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. Here "number of subjects analysed"=subjects evaluable for this endpoint and ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for Co-ad and PCV13 groups.

End point type

Primary

End point timeframe

At Year 5

Notes
[15] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.
[16] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group
Number of subjects analysed	133	117
Units: titers (1/dilution)
geometric mean (confidence interval 95%)
rSBA-MenA (n=133, 117)	46.8 (30.7 to 71.5)	69.9 (44.7 to 109.3)
rSBA-MenC (n=132, 116)	6.6 (5.3 to 8.2)	8.5 (6.4 to 11.2)
rSBA-MenW-135 (n=133, 117)	25.0 (16.7 to 37.6)	37.1 (23.3 to 59.0)
rSBA-MenY (n=133, 117)	36.5 (23.6 to 56.2)	55.8 (35.7 to 87.5)

No statistical analyses for this end point

Primary: Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

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End point title

Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups ^[17] ^[18]

End point description

GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per millilitre (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable subjects who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2 (Month 1), and had available blood sample at Visit 2 (Month 1) for PCV13 group. Here "number of subjects analysed" signifies subjects evaluable for this endpoint and ‘number analysed’ signifies subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for ACWY1d and ACWY2d reporting groups.

End point type

Primary

End point timeframe

1 month after administration of Prevnar 13 (i.e. at Month 1)

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: Statistical analyses was not planned for this endpoint only descriptive data was planned.
[18] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	Co-ad Group	PCV13 Group
Number of subjects analysed	163	172
Units: mcg/mL
geometric mean (confidence interval 95%)
anti-1 (n=162, 171)	2.94 (2.56 to 3.36)	2.62 (2.27 to 3.01)
anti-3 (n=151, 162)	0.80 (0.69 to 0.91)	0.71 (0.62 to 0.81)
anti-4 (n=163, 172)	2.46 (2.14 to 2.83)	1.96 (1.69 to 2.26)
anti-5 (n=163, 172)	2.09 (1.84 to 2.37)	1.67 (1.46 to 1.91)
anti-6A (n=163, 171)	8.59 (7.50 to 9.85)	7.28 (6.33 to 8.37)
anti-6B (n=161, 171)	7.36 (6.33 to 8.55)	6.68 (5.70 to 7.83)
anti-7F (n=163, 172)	5.14 (4.49 to 5.88)	4.81 (4.23 to 5.47)
anti-9V (n=163, 172)	2.03 (1.78 to 2.30)	1.79 (1.59 to 2.03)
anti-14 (n=161, 172)	13.1 (11.38 to 15.07)	11.94 (10.43 to 13.66)
anti-18C (n=163, 172)	2.53 (2.19 to 2.92)	2.13 (1.84 to 2.47)
anti-19A (n=162, 170)	9.60 (8.41 to 10.97)	8.62 (7.53 to 9.87)
anti-19F (n=162, 172)	8.40 (7.33 to 9.62)	7.98 (6.96 to 9.15)
anti-23F (n=161, 169)	5.33 (4.57 to 6.21)	4.47 (3.83 to 5.23)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups

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End point title

Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups ^[19]

End point description

Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135), Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. "Number of subjects analysed"=subjects evaluable for this endpoint and ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for Co-ad and PCV13 groups.

End point type

Secondary

End point timeframe

1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

Notes
[19] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group
Number of subjects analysed	78	70
Units: percentage of subjects
number (confidence interval 95%)
hSBA-MenA: >=1:4 (n=74, 66)	95.9 (88.6 to 99.2)	97.0 (89.5 to 99.6)
hSBA-MenC: >=1:4 (n=78, 70)	98.7 (93.1 to 100.0)	97.1 (90.1 to 99.7)
hSBA-MenW-135: >=1:4 (n=72, 61)	62.5 (50.3 to 73.6)	68.9 (55.7 to 80.1)
hSBA-MenY: >=1:4 (n=71, 56)	67.6 (55.5 to 78.2)	64.3 (50.4 to 76.6)
hSBA-MenA: >=1:8 (n=74, 66)	95.9 (88.6 to 99.2)	97.0 (89.5 to 99.6)
hSBA-MenC: >=1:8 (n=78, 70)	98.7 (93.1 to 100.0)	95.7 (88.0 to 99.1)
hSBA-MenW-135: >=1:8 (n=72, 61)	62.5 (50.3 to 73.6)	68.9 (55.7 to 80.1)
hSBA-MenY: >=1:8 (n=71, 56)	67.6 (55.5 to 78.2)	64.3 (50.4 to 76.6)

No statistical analyses for this end point

Secondary: Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

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End point title

Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group ^[20]

End point description

Serogroups:Neisseria meningitidis serogroup A (MenA),Neisseria meningitidis serogroup C (MenC),Neisseria meningitidis serogroup W-135 (MenW-135),Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT reported. ATP cohort for persistence Year 1 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. "Number of subjects analysed"=subjects evaluable for this endpoint. ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for ACWY1d, Co-ad and PCV13 groups.

End point type

Secondary

End point timeframe

1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

Notes
[20] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY2d Group
Number of subjects analysed	70
Units: percentage of subjects
number (confidence interval 95%)
hSBA-MenA: >=1:4 (n= 66)	97.0 (89.5 to 99.6)
hSBA-MenC: >=1:4 (n= 69)	100.0 (94.8 to 100.0)
hSBA-MenW-135: >=1:4 (n= 70)	97.1 (90.1 to 99.7)
hSBA-MenY: >=1:4 (n= 64)	95.3 (86.9 to 99.0)
hSBA-MenA: >=1:8 (n= 66)	97.0 (89.5 to 99.6)
hSBA-MenC: >=1:8 (n= 69)	100.0 (94.8 to 100.0)
hSBA-MenW-135: >=1:8 (n= 70)	97.1 (90.1 to 99.7)
hSBA-MenY: >=1:8 (n= 64)	95.3 (86.9 to 99.0)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups

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End point title

Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups ^[21]

End point description

GMTs of antibodies against each serogroup were assessed using hSBA. Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. "Number of subjects analysed"=subjects evaluable for this endpoint and ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for Co-ad and PCV13 groups.

End point type

Secondary

End point timeframe

1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

Notes
[21] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group
Number of subjects analysed	78	70
Units: titers (1/dilution)
geometric mean (confidence interval 95%)
hSBA-MenA (n=74, 66)	118.0 (86.8 to 160.5)	132.9 (98.1 to 180.1)
hSBA-MenC (n=78, 70)	151.9 (104.8 to 220.4)	160.8 (109.8 to 235.5)
hSBA-MenW-135 (n=72, 61)	27.5 (16.1 to 46.8)	26.2 (16.0 to 43.0)
hSBA-MenY (n=71, 56)	41.2 (23.7 to 71.5)	31.9 (17.6 to 57.9)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

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End point title

Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group ^[22]

End point description

End point type

Secondary

End point timeframe

1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

Notes
[22] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY2d Group
Number of subjects analysed	70
Units: titers (1/dilution)
geometric mean (confidence interval 95%)
hSBA-MenA (n= 66)	170.5 (126.2 to 230.2)
hSBA-MenC (n= 69)	1753.3 (1278.7 to 2404.2)
hSBA-MenW-135 (n= 70)	756.8 (550.1 to 1041.3)
hSBA-MenY (n= 64)	513.0 (339.4 to 775.4)

No statistical analyses for this end point

Secondary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group

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End point title

Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group ^[23]

End point description

Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with rSBA titers >=1:8 and >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. Here "number of subjects analysed" signifies subjects evaluable for this endpoint. Data for this endpoint was not planned to be collected and analysed for ACWY1d, ACWY2d and Co-ad reporting groups.

End point type

Secondary

End point timeframe

1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)

Notes
[23] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	PCV13 Group
Number of subjects analysed	169
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA: >=1:8	96.4 (92.4 to 98.7)
rSBA-MenC: >=1:8	95.3 (90.9 to 97.9)
rSBA-MenW-135: >=1:8	96.4 (92.4 to 98.7)
rSBA-MenY: >=1:8	97.0 (93.2 to 99.0)
rSBA-MenA: >=1:128	95.9 (91.7 to 98.3)
rSBA-MenC: >=1:128	85.8 (79.6 to 90.7)
rSBA-MenW-135: >=1:128	96.4 (92.4 to 98.7)
rSBA-MenY: >=1:128	97.0 (93.2 to 99.0)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group

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End point title

Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group ^[24]

End point description

End point type

Secondary

End point timeframe

1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)

Notes
[24] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	PCV13 Group
Number of subjects analysed	169
Units: titers (1/dilution)
geometric mean (confidence interval 95%)
rSBA-MenA	1957.7 (1513.4 to 2532.3)
rSBA-MenC	376.4 (284.7 to 497.6)
rSBA-MenW-135	3490.5 (2643.3 to 4609.3)
rSBA-MenY	1481.2 (1158.4 to 1893.9)

No statistical analyses for this end point

Secondary: Percentage of Subjects With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups

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End point title

Percentage of Subjects With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups ^[25]

End point description

Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with rSBA titers >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. "Number of subjects analysed"=subjects evaluable for this endpoint and ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for PCV13 group.

End point type

Secondary

End point timeframe

1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

Notes
[25] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group	Co-ad Group
Number of subjects analysed	180	158	178
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA (n=180, 158, 178)	94.4 (90.0 to 97.3)	95.6 (91.1 to 98.2)	93.8 (89.2 to 96.9)
rSBA-MenC (n=179, 157, 176)	85.5 (79.4 to 90.3)	85.4 (78.8 to 90.5)	88.1 (82.3 to 92.5)
rSBA-MenW-135 (n=180, 158, 177)	95.0 (90.7 to 97.7)	94.3 (89.5 to 97.4)	92.7 (87.8 to 96.0)
rSBA-MenY (n=180, 157, 177)	90.6 (85.3 to 94.4)	91.7 (86.3 to 95.5)	89.3 (83.7 to 93.4)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups

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End point title

Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups ^[26]

End point description

GMTs of antibodies against each serogroup were assessed using rSBA. Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. "Number of subjects analysed"=subjects evaluable for this endpoint and ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for PCV13 group.

End point type

Secondary

End point timeframe

1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

Notes
[26] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group	Co-ad Group
Number of subjects analysed	180	158	178
Units: titers (1/dilution)
geometric mean (confidence interval 95%)
rSBA-MenA (n=180, 158, 178)	1437.0 (1118.3 to 1846.6)	1275.2 (970.5 to 1675.4)	1146.4 (867.9 to 1514.3)
rSBA-MenC (n=179, 157, 176)	452.3 (345.6 to 591.9)	369.3 (280.9 to 485.5)	337.3 (263.8 to 431.1)
rSBA-MenW-135 (n=180, 158, 177)	2120.2 (1601.0 to 2807.8)	2030.1 (1510.7 to 2728.2)	1550.9 (1137.4 to 2114.7)
rSBA-MenY (n=180, 157, 177)	951.8 (705.0 to 1284.9)	933.3 (692.3 to 1258.3)	778.5 (566.2 to 1070.4)

No statistical analyses for this end point

Secondary: Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups

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End point title

Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups ^[27]

End point description

Serogroups:Neisseria meningitidis serogroup A (MenA),Neisseria meningitidis serogroup C (MenC),Neisseria meningitidis serogroup W-135 (MenW-135),Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with hSBA titers >=1:4 and >=1:8 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT reported. ATP cohort for persistence Year 1, 3 and 5 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. "Number of subjects analysed"=subjects evaluable for this endpoint. ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for Co-ad and PCV13 groups.

End point type

Secondary

End point timeframe

At Year 1, Year 3, Year 5

Notes
[27] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group
Number of subjects analysed	72	65
Units: percentage of subjects
number (confidence interval 95%)
hSBA-MenA: >=1:4 (Year 1) (n=70, 62)	37.1 (25.9 to 49.5)	35.5 (23.7 to 48.7)
hSBA-MenC: >=1:4 (Year 1) (n=71, 63)	81.7 (70.7 to 89.9)	93.7 (84.5 to 98.2)
hSBA-MenW-135: >=1:4 (Year 1) (n=72, 65)	95.8 (88.3 to 99.1)	98.5 (91.7 to 100.0)
hSBA-MenY: >=1:4 (Year 1) (n=62, 58)	91.9 (82.2 to 97.3)	87.9 (76.7 to 95.0)
hSBA-MenA: >=1:8 (Year 1) (n=70, 62)	35.7 (24.6 to 48.1)	35.5 (23.7 to 48.7)
hSBA-MenC: >=1:8 (Year 1) (n=71, 63)	80.3 (69.1 to 88.8)	90.5 (80.4 to 96.4)
hSBA-MenW-135: >=1:8 (Year 1) (n=72, 65)	95.8 (88.3 to 99.1)	98.5 (91.7 to 100.0)
hSBA-MenY: >=1:8 (Year 1) (n=62, 58)	91.9 (82.2 to 97.3)	87.9 (76.7 to 95.0)
hSBA-MenA: >=1:4 (Year 3) (n=55, 50)	36.4 (23.8 to 50.4)	36.0 (22.9 to 50.8)
hSBA-MenC: >=1:4 (Year 3) (n=61, 56)	65.6 (52.3 to 77.3)	67.9 (54.0 to 79.7)
hSBA-MenW-135: >=1:4 (Year 3) (n=67, 54)	71.6 (59.3 to 82.0)	87.0 (75.1 to 94.6)
hSBA-MenY: >=1:4 (Year 3) (n=64, 52)	53.1 (40.2 to 65.7)	61.5 (47.0 to 74.7)
hSBA-MenA: >=1:8 (Year 3) (n=55, 50)	36.4 (23.8 to 50.4)	36.0 (22.9 to 50.8)
hSBA-MenC: >=1:8 (Year 3) (n=61, 56)	65.6 (52.3 to 77.3)	67.9 (54.0 to 79.7)
hSBA-MenW-135: >=1:8 (Year 3) (n=67, 54)	71.6 (59.3 to 82.0)	87.0 (75.1 to 94.6)
hSBA-MenY: >=1:8 (Year 3) (n=64, 52)	53.1 (40.2 to 65.7)	61.5 (47.0 to 74.7)
hSBA-MenA: >=1:4 (Year 5) (n=61, 56)	27.9 (17.1 to 40.8)	17.9 (8.9 to 30.4)
hSBA-MenC: >=1:4 (Year 5) (n=61, 59)	60.7 (47.3 to 72.9)	67.8 (54.4 to 79.4)
hSBA-MenW-135: >=1:4 (Year 5) (n=56, 44)	58.9 (45.0 to 71.9)	63.6 (47.8 to 77.6)
hSBA-MenY: >=1:4 (Year 5) (n=65, 48)	61.5 (48.6 to 73.3)	54.2 (39.2 to 68.6)
hSBA-MenA: >=1:8 (Year 5) (n=61, 56)	27.9 (17.1 to 40.8)	17.9 (8.9 to 30.4)
hSBA-MenC: >=1:8 (Year 5) (n=61, 59)	60.7 (47.3 to 72.9)	67.8 (54.4 to 79.4)
hSBA-MenW-135: >=1:8 (Year 5) (n=56, 44)	58.9 (45.0 to 71.9)	63.6 (47.8 to 77.6)
hSBA-MenY: >=1:8 (Year 5) (n=65, 48)	61.5 (48.6 to 73.3)	54.2 (39.2 to 68.6)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups

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End point title

Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups ^[28]

End point description

GMTs of antibodies against each serogroup were assessed using hSBA. Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. "Number of subjects analysed"=subjects evaluable for this endpoint and ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for Co-ad and PCV13 groups.

End point type

Secondary

End point timeframe

At Year 1, Year 3, Year 5

Notes
[28] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	ACWY1d Group	ACWY2d Group
Number of subjects analysed	72	65
Units: titers (1/dilution)
geometric mean (confidence interval 95%)
hSBA-MenA (Year 1) (n=70, 62)	6.1 (4.1 to 8.9)	6.4 (4.2 to 10.0)
hSBA-MenC (Year 1) (n=71, 63)	35.2 (22.5 to 55.2)	73.4 (47.5 to 113.4)
hSBA-MenW-135 (Year 1) (n=72, 65)	209.0 (149.9 to 291.4)	232.6 (168.3 to 321.4)
hSBA-MenY (Year 1) (n=62, 58)	144.4 (97.2 to 214.5)	143.9 (88.5 to 233.8)
hSBA-MenA (Year 3) (n=55, 50)	5.8 (3.8 to 8.9)	5.4 (3.6 to 8.0)
hSBA-MenC (Year 3) (n=61, 56)	23.6 (13.9 to 40.2)	27.0 (15.6 to 46.8)
hSBA-MenW-135 (Year 3) (n=67, 54)	30.5 (18.7 to 49.6)	55.5 (35.3 to 87.1)
hSBA-MenY (Year 3) (n=64, 52)	17.3 (10.1 to 29.6)	24.1 (13.3 to 43.8)
hSBA-MenA (Year 5) (n=61, 56)	4.4 (3.1 to 6.2)	3.1 (2.4 to 4.0)
hSBA-MenC (Year 5) (n=61, 59)	18.1 (10.9 to 30.0)	29.4 (16.3 to 52.9)
hSBA-MenW-135 (Year 5) (n=56, 44)	20.8 (11.6 to 37.1)	19.5 (10.7 to 35.2)
hSBA-MenY (Year 5) (n=65, 48)	24.3 (14.3 to 41.1)	16.8 (9.0 to 31.3)

No statistical analyses for this end point

Secondary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups

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End point title

Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups ^[29]

End point description

Serogroups:Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC),Neisseria meningitidis serogroup W-135 (MenW-135),Neisseria meningitidis serogroup Y (MenY). Percentage of subjects with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT reported. ATP cohort for persistence Year 1, 3 and 5 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at previous time point. "Number of subjects analysed"=subjects evaluable for this endpoint. ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for ACWY1d and ACWY2d groups.

End point type

Secondary

End point timeframe

At Year 1, Year 3, Year 5

Notes
[29] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	Co-ad Group	PCV13 Group
Number of subjects analysed	173	169
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA: >=1:8 (Year 1) (n=173, 169)	66.5 (58.9 to 73.5)	70.4 (62.9 to 77.2)
rSBA-MenC: >=1:8 (Year 1) (n=171, 169)	42.7 (35.2 to 50.5)	50.3 (42.5 to 58.1)
rSBA-MenW-135: >=1:8 (Year 1) (n=171, 169)	60.2 (52.5 to 67.6)	72.8 (65.4 to 79.3)
rSBA-MenY: >=1:8 (Year 1) (n=173, 169)	67.1 (59.5 to 74.0)	80.5 (73.7 to 86.2)
rSBA-MenA: >=1:128 (Year 1) (n=173, 169)	42.8 (35.3 to 50.5)	56.2 (48.4 to 63.8)
rSBA-MenC: >=1:128 (Year 1) (n=171, 169)	15.8 (10.7 to 22.1)	20.1 (14.4 to 27.0)
rSBA-MenW-135: >=1:128 (Year 1) (n=171, 169)	42.7 (35.2 to 50.5)	58.0 (50.2 to 65.5)
rSBA-MenY: >=1:128 (Year 1) (n=173, 169)	53.8 (46.0 to 61.4)	69.2 (61.7 to 76.1)
rSBA-MenA: >=1:8 (Year 3) (n=151, 132)	51.0 (42.7 to 59.2)	53.8 (44.9 to 62.5)
rSBA-MenC: >=1:8 (Year 3) (n=151, 132)	28.5 (21.4 to 36.4)	31.8 (24.0 to 40.5)
rSBA-MenW-135: >=1:8 (Year 3) (n=151, 132)	53.0 (44.7 to 61.1)	56.8 (47.9 to 65.4)
rSBA-MenY: >=1:8 (Year 3) (n=151, 132)	62.9 (54.7 to 70.6)	73.5 (65.1 to 80.8)
rSBA-MenA: >=1:128 (Year 3) (n=151, 132)	39.1 (31.2 to 47.3)	40.2 (31.7 to 49.0)
rSBA-MenC: >=1:128 (Year 3) (n=151, 132)	14.6 (9.4 to 21.2)	10.6 (5.9 to 17.2)
rSBA-MenW-135: >=1:128 (Year 3) (n=151, 132)	39.1 (31.2 to 47.3)	42.4 (33.9 to 51.3)
rSBA-MenY: >=1:128 (Year 3) (n=151, 132)	53.0 (44.7 to 61.1)	59.8 (51.0 to 68.3)
rSBA-MenA: >=1:8 (Year 5) (n=142, 129)	45.8 (37.4 to 54.3)	47.3 (38.4 to 56.3)
rSBA-MenC: >=1:8 (Year 5) (n=142, 129)	23.9 (17.2 to 31.8)	19.4 (13.0 to 27.3)
rSBA-MenW-135: >=1:8 (Year 5) (n=142, 129)	43.0 (34.7 to 51.5)	45.0 (36.2 to 54.0)
rSBA-MenY: >=1:8 (Year 5) (n=142, 129)	52.8 (44.3 to 61.2)	55.8 (46.8 to 64.5)
rSBA-MenA: >=1:128 (Year 5) (n=142, 129)	19.0 (12.9 to 26.4)	36.4 (28.1 to 45.4)
rSBA-MenC: >=1:128 (Year 5) (n=142, 129)	12.0 (7.1 to 18.5)	7.8 (3.8 to 13.8)
rSBA-MenW-135: >=1:128 (Year 5) (n=142, 129)	33.8 (26.1 to 42.2)	35.7 (27.4 to 44.6)
rSBA-MenY: >=1:128 (Year 5) (n=142, 129)	42.3 (34.0 to 50.8)	48.1 (39.2 to 57.0)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups

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End point title

Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups ^[30]

End point description

GMTs of antibodies against each serogroup were assessed using rSBA. Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all subjects who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. "Number of subjects analysed"=subjects evaluable for this endpoint and ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for ACWY1d and ACWY2d groups.

End point type

Secondary

End point timeframe

At Year 1, Year 3, Year 5

Notes
[30] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	Co-ad Group	PCV13 Group
Number of subjects analysed	173	169
Units: titers (1/dilution)
geometric mean (confidence interval 95%)
rSBA-MenA (Year 1) (n=173, 169)	59.5 (40.7 to 87.2)	119.4 (79.5 to 179.3)
rSBA-MenC (Year 1) (n=171, 169)	12.6 (10.0 to 16.0)	16.0 (12.2 to 20.9)
rSBA-MenW-135 (Year 1) (n=171, 169)	52.0 (35.5 to 76.4)	109.5 (75.0 to 160.0)
rSBA-MenY (Year 1) (n=173, 169)	70.7 (49.0 to 102.1)	169.2 (119.2 to 240.1)
rSBA-MenA (Year 3) (n=151, 132)	38.6 (25.4 to 58.8)	42.3 (27.2 to 65.6)
rSBA-MenC (Year 3) (n=151, 132)	9.1 (7.1 to 11.6)	9.3 (7.1 to 12.1)
rSBA-MenW-135 (Year 3) (n=151, 132)	34.4 (23.4 to 50.6)	44.5 (28.9 to 68.7)
rSBA-MenY (Year 3) (n=151, 132)	67.6 (45.6 to 100.3)	106.0 (70.2 to 160.0)
rSBA-MenA (Year 5) (n=142, 129)	15.4 (11.1 to 21.3)	28.3 (18.5 to 43.2)
rSBA-MenC (Year 5) (n=142, 129)	7.9 (6.2 to 10.0)	7.0 (5.5 to 8.8)
rSBA-MenW-135 (Year 5) (n=142, 129)	26.2 (17.6 to 39.0)	31.7 (20.2 to 49.6)
rSBA-MenY (Year 5) (n=142, 129)	43.3 (28.3 to 66.2)	53.9 (34.5 to 84.2)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

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End point title

Percentage of Subjects With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups ^[31]

End point description

Antibody concentrations determined for anti-pneumococcal antibodies:anti-1,anti-3,anti-4,anti-5,anti-6A,anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F, anti-23F. Percentage of subjects with antibody concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL against each serogroup at 1 month after administration of Prevnar 13 reported. ATP cohort for immunogenicity post dose 1: all evaluable subjects who met eligibility criteria, complied with procedures defined in protocol with no elimination criteria during study from ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least 1 study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group. "Number of subjects analysed"=subjects evaluable for this endpoint. ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for ACWY1d and ACWY2d groups.

End point type

Secondary

End point timeframe

1 month after administration of Prevnar 13 (i.e. at Month 1)

Notes
[31] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	Co-ad Group	PCV13 Group
Number of subjects analysed	163	172
Units: percentage of subjects
number (confidence interval 95%)
anti-1 (>=0.15 mcg/mL) (n=162, 171)	100 (97.7 to 100)	100 (97.9 to 100)
anti-3 (>=0.15 mcg/mL) (n=151, 162)	99.3 (96.4 to 100)	97.5 (93.8 to 99.3)
anti-4 (>=0.15 mcg/mL) (n=163, 172)	100 (97.8 to 100)	99.4 (96.8 to 100)
anti-5 (>=0.15 mcg/mL) (n=163, 172)	100 (97.8 to 100)	100 (97.9 to 100)
anti-6A (>=0.15 mcg/mL) (n=163, 171)	100 (97.8 to 100)	100 (97.9 to 100)
anti-6B (>=0.15 mcg/mL) (n=161, 171)	100 (97.7 to 100)	99.4 (96.8 to 100)
anti-7F (>=0.15 mcg/mL) (n=163, 172)	100 (97.8 to 100)	100 (97.9 to 100)
anti-9V (>=0.15 mcg/mL) (n=163, 172)	99.4 (96.6 to 100)	100 (97.9 to 100)
anti-14 (>=0.15 mcg/mL) (n=161, 172)	100 (97.7 to 100)	99.4 (96.8 to 100)
anti-18C (>=0.15 mcg/mL) (n=163, 172)	100 (97.8 to 100)	100 (97.9 to 100)
anti-19A (>=0.15 mcg/mL) (n=162, 170)	100 (97.7 to 100)	100 (97.9 to 100)
anti-19F (>=0.15 mcg/mL) (n=162, 172)	100 (97.7 to 100)	100 (97.9 to 100)
anti-23F (>=0.15 mcg/mL) (n=161, 169)	100 (97.7 to 100)	100 (97.8 to 100)
anti-1 (>=0.26 mcg/mL) (n=162, 171)	99.4 (96.6 to 100)	99.4 (96.8 to 100)
anti-3 (>=0.26 mcg/mL) (n=151, 162)	94.0 (89.0 to 97.2)	88.3 (82.3 to 92.8)
anti-4 (>=0.26 mcg/mL) (n=163, 172)	98.8 (95.6 to 99.9)	98.3 (95.0 to 99.6)
anti-5 (>=0.26 mcg/mL) (n=163, 172)	99.4 (96.6 to 100)	98.8 (95.9 to 99.9)
anti-6A (>=0.26 mcg/mL) (n=163, 171)	100 (97.8 to 100)	100 (97.9 to 100)
anti-6B (>=0.26 mcg/mL) (n=161, 171)	100 (97.7 to 100)	99.4 (96.8 to 100)
anti-7F (>=0.26 mcg/mL) (n=163, 172)	100 (97.8 to 100)	100 (97.9 to 100)
anti-9V (>=0.26 mcg/mL) (n=163, 172)	99.4 (96.6 to 100)	98.8 (95.9 to 99.9)
anti-14 (>=0.26 mcg/mL) (n=161, 172)	100 (97.7 to 100)	99.4 (96.8 to 100)
anti-18C (>=0.26 mcg/mL) (n=163, 172)	98.8 (95.6 to 99.9)	99.4 (96.8 to 100)
anti-19A (>=0.26 mcg/mL) (n=162, 170)	100 (97.7 to 100)	100 (97.9 to 100)
anti-19F (>=0.26 mcg/mL) (n=162, 172)	100 (97.7 to 100)	100 (97.9 to 100)
anti-23F (>=0.26 mcg/mL) (n=161, 169)	99.4 (96.6 to 100)	99.4 (96.7 to 100)
anti-1 (>=0.35 mcg/mL) (n=162, 171)	99.4 (96.6 to 100)	98.2 (95.0 to 99.6)
anti-3 (>=0.35 mcg/mL) (n=151, 162)	83.4 (76.5 to 89.0)	79.0 (71.9 to 85.0)
anti-4 (>=0.35 mcg/mL) (n=163, 172)	96.9 (93.0 to 99.0)	97.1 (93.3 to 99.0)
anti-5 (>=0.35 mcg/mL) (n=163, 172)	98.8 (95.6 to 99.9)	94.8 (90.3 to 97.6)
anti-6A (>=0.35 mcg/mL) (n=163, 171)	99.4 (96.6 to 100)	100 (97.9 to 100)
anti-6B (>=0.35 mcg/mL) (n=161, 171)	99.4 (96.6 to 100)	99.4 (96.8 to 100)
anti-7F (>=0.35 mcg/mL) (n=163, 172)	99.4 (96.6 to 100)	100 (97.9 to 100)
anti-9V (>=0.35 mcg/mL) (n=163, 172)	99.4 (96.6 to 100)	97.7 (94.2 to 99.4)
anti-14 (>=0.35 mcg/mL) (n=161, 172)	100 (97.7 to 100)	99.4 (96.8 to 100)
anti-18C (>=0.35 mcg/mL) (n=163, 172)	98.8 (95.6 to 99.9)	99.4 (96.8 to 100)
anti-19A (>=0.35 mcg/mL) (n=162, 170)	100 (97.7 to 100)	100 (97.9 to 100)
anti-19F (>=0.35 mcg/mL) (n=162, 172)	100 (97.7 to 100)	100 (97.9 to 100)
anti-23F (>=0.35 mcg/mL) (n=161, 169)	99.4 (96.6 to 100)	99.4 (96.7 to 100)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

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End point title

Percentage of Subjects With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups ^[32]

End point description

OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1,OPSONO-3,OPSONO-4,OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F, OPSONO-23F. Percentage of subjects with OPA titers >=1:8 against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1: all evaluable subjects who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group. "Number of subjects analysed"=subjects evaluable for this endpoint. ‘n’=subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for ACWY1d and ACWY2d groups.

End point type

Secondary

End point timeframe

1 month after administration of Prevnar 13 (i.e. at Month 1)

Notes
[32] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	Co-ad Group	PCV13 Group
Number of subjects analysed	81	88
Units: percentage of subjects
number (confidence interval 95%)
OPSONO-1 (n=81, 86)	93.8 (86.2 to 98.0)	90.7 (82.5 to 95.9)
OPSONO-3 (n=76, 80)	98.7 (92.9 to 100)	100 (95.5 to 100)
OPSONO-4 (n=77, 80)	100 (95.3 to 100)	100 (95.5 to 100)
OPSONO-5 (n=81, 87)	100 (95.5 to 100)	100 (95.8 to 100)
OPSONO-6A (n=81, 88)	100 (95.5 to 100)	100 (95.9 to 100)
OPSONO-6B (n=75, 78)	100 (95.2 to 100)	100 (95.4 to 100)
OPSONO-7F (n=81, 87)	100 (95.5 to 100)	100 (95.8 to 100)
OPSONO-9V (n=81, 88)	100 (95.5 to 100)	100 (95.9 to 100)
OPSONO-14 (n=73, 78)	100 (95.1 to 100)	100 (95.4 to 100)
OPSONO-18C (n=81, 88)	100 (95.5 to 100)	100 (95.9 to 100)
OPSONO-19A (n=81, 88)	100 (95.5 to 100)	100 (95.9 to 100)
OPSONO-19F (n=81, 88)	98.8 (93.3 to 100)	100 (95.9 to 100)
OPSONO-23F (n=77, 80)	98.7 (93.0 to 100)	98.8 (93.2 to 100)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

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End point title

Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups ^[33]

End point description

OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. OPA titers are expressed as 1/dilution. ATP cohort for immunogenicity post dose 1 included all evaluable subjects who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group. Here "number of subjects analysed" signifies subjects evaluable for this endpoint and ‘number analysed’ signifies subjects evaluable for each specified category. Data for this endpoint was not planned to be collected and analysed for ACWY1d and ACWY2d reporting groups.

End point type

Secondary

End point timeframe

1 month after administration of Prevnar 13 (i.e. at Month 1)

Notes
[33] - 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: Statistical analyses was not planned for this endpoint only descriptive data was planned.

End point values	Co-ad Group	PCV13 Group
Number of subjects analysed	81	88
Units: titers
geometric mean (confidence interval 95%)
OPSONO-1 (n=81, 86)	116.1 (83.8 to 160.7)	106.1 (77.0 to 146.2)
OPSONO-3 (n=76, 80)	137.6 (106.4 to 178.0)	122.0 (100.6 to 147.9)
OPSONO-4 (n=77, 80)	2194.8 (1660.0 to 2901.9)	2210.1 (1735.0 to 2815.2)
OPSONO-5 (n=81, 87)	452.3 (360.4 to 567.5)	404.6 (319.1 to 512.9)
OPSONO-6A (n=81, 88)	10177.2 (7784.7 to 13305.1)	7354.2 (5707.4 to 9476.1)
OPSONO-6B (n=75, 78)	4952.3 (3734.4 to 6567.4)	3881.5 (3055.8 to 4930.2)
OPSONO-7F (n=81, 87)	8957.4 (7306.4 to 10981.5)	8526.5 (6926.2 to 10496.7)
OPSONO-9V (n=81, 88)	3375.5 (2539.6 to 4486.6)	2332.3 (1766.1 to 3080.1)
OPSONO-14 (n=73, 78)	3443.7 (2453.5 to 4833.5)	3157.8 (2445.4 to 4077.8)
OPSONO-18C (n=81, 88)	3881.0 (2947.2 to 5110.7)	3289.8 (2513.7 to 4305.5)
OPSONO-19A (n=81, 88)	3362.5 (2639.6 to 4283.4)	2494.3 (1986.7 to 3131.6)
OPSONO-19F (n=81, 88)	1795.5 (1305.6 to 2469.2)	1647.6 (1287.6 to 2108.3)
OPSONO-23F (n=77, 80)	7755.7 (5450.9 to 11034.9)	5677.4 (4255.0 to 7575.3)

No statistical analyses for this end point

Secondary: Number of Subjects With Solicited Local Reactions Within 4 Days Post Each Vaccination

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End point title

Number of Subjects With Solicited Local Reactions Within 4 Days Post Each Vaccination

End point description

Solicited local reactions included pain, redness and swelling. Here, '99999' in the number analysed field signifies that no vaccine was administered in the specified group for the specified category. The total vaccinated cohort (TVC) included all subjects vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. Here "number of subjects analysed" signifies subjects evaluable for this endpoint and ‘number analysed’ signifies subjects evaluable for each specified category.

End point type

Secondary

End point timeframe

Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2])

End point values	ACWY1d Group	ACWY2d Group	Co-ad Group	PCV13 Group
Number of subjects analysed	199	196	197	197
Units: subjects
Pain:Post MenACWY-TT Dose 1 (n=199, 195, 197, 0)	52	64	72	99999
Pain:Post Prevenar 13 Dose 1 (n=0, 0, 196, 196)	99999	99999	85	72
Pain:Post MenACWY-TT Dose 2 (n=0, 189, 0, 191)	99999	58	99999	53
Redness:Post MenACWY-TT Dose 1 (n=199,195,197,0)	68	73	73	99999
Redness:Post Prevenar 13 Dose 1 (n=0,0,196,196)	99999	99999	87	90
Redness:Post MenACWY-TT Dose 2 (n=0,189,0,191)	99999	64	99999	66
Swelling:Post MenACWY-TT Dose 1 (n=199,195,197,0)	35	45	43	99999
Swelling:Post Prevenar 13 Dose 1 (n=0,0,196,196)	99999	99999	69	63
Swelling:Post MenACWY-TT Dose 2 (n=0,189,0,191)	99999	34	99999	30

No statistical analyses for this end point

Secondary: Number of Subjects With Solicited General Reactions Within 4 Days Post Each Vaccination

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End point title

Number of Subjects With Solicited General Reactions Within 4 Days Post Each Vaccination

End point description

Solicited general reactions included drowsiness, irritability/fussiness, loss of appetite and fever. Here, '99999' in the number analysed field signifies that no vaccine was administered in the specified group for the specified category. Post dose 1 for ACWY1d and Co-ad group included reactions occurred after dosing of both MenACWY-TT and Prevenar 13 for Co-ad group and data was collected and summarised collectively. The total vaccinated cohort (TVC) included all subjects vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. Here "number of subjects analysed" signifies subjects evaluable for this endpoint and ‘number analysed’ signifies subjects evaluable for each specified category.

End point type

Secondary

End point timeframe

Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2])

End point values	ACWY1d Group	ACWY2d Group	Co-ad Group	PCV13 Group
Number of subjects analysed	199	196	197	197
Units: subjects
Drowsiness:Post Dose 1 (n=199,195,197,196)	62	73	85	72
Drowsiness:Post Dose 2 (n=0,189,0,191)	99999	60	99999	50
Irritable/Fussiness:PostDose1(n=199,195,197,196)	89	93	107	85
Irritability/Fussiness:Post Dose 2(n=0,189,0,191)	99999	76	99999	67
Loss of Appetite:Post Dose 1 (n=199,195,197,196)	56	60	54	58
Loss of Appetite:Post Dose 2 (n=0,189,0,191)	99999	45	99999	47
Fever:Post Dose 1 (n=199,195,197,196)	26	25	34	43
Fever:Post Dose 2 (n=0,189,0,191)	99999	23	99999	25

No statistical analyses for this end point

Secondary: Number of Subjects With Unsolicited Adverse Events Within 31 Days Post any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)

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End point title

Number of Subjects With Unsolicited Adverse Events Within 31 Days Post any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)

End point description

An adverse event was any untoward medical occurrence in a subject, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event was an observed adverse event that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. The total vaccinated cohort (TVC) included all subjects vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.

End point type

Secondary

End point timeframe

Within 31 days post any vaccination

End point values	ACWY1d Group	ACWY2d Group	Co-ad Group	PCV13 Group
Number of subjects analysed	203	197	201	201
Units: subjects	11	15	11	11

No statistical analyses for this end point

Secondary: Number of Subjects With Serious Adverse Events from Month 0 to Month 9

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End point title

Number of Subjects With Serious Adverse Events from Month 0 to Month 9

End point description

An adverse event was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. The total vaccinated cohort (TVC) included all subjects vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.

End point type

Secondary

End point timeframe

Month 0 to Month 9

End point values	ACWY1d Group	ACWY2d Group	Co-ad Group	PCV13 Group
Number of subjects analysed	203	197	201	201
Units: subjects	8	6	10	5

No statistical analyses for this end point

Secondary: Number of Subjects With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study

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End point title

Number of Subjects With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study

End point description

An adverse event was any untoward medical occurrence in a subject who received study drug. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Related adverse events were those adverse events who were related to the vaccination as judged by the investigator. The total vaccinated cohort (TVC) included all subjects vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.

End point type

Secondary

End point timeframe

Baseline up to end of study (up to 5 years)

End point values	ACWY1d Group	ACWY2d Group	Co-ad Group	PCV13 Group
Number of subjects analysed	203	197	201	201
Units: subjects	0	2	1	0

No statistical analyses for this end point

Secondary: Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs) from Month 0 to Month 9

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End point title

Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs) from Month 0 to Month 9

End point description

New onset chronic illness included autoimmune disorders, asthma, type I diabetes and allergies. The total vaccinated cohort (TVC) included all subjects vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.

End point type

Secondary

End point timeframe

Month 0 to Month 9

End point values	ACWY1d Group	ACWY2d Group	Co-ad Group	PCV13 Group
Number of subjects analysed	203	197	201	201
Units: subjects	2	3	1	5

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.

Adverse event reporting additional description

Same event may appear as both an adverse event and serious adverse events. 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.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

ACWY1d Group

Reporting group description

Subjects received single dose of MenACWY-TT vaccine administered intramuscularly at Month 0.

Reporting group title

Co-ad Group

Reporting group description

Subjects received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.

Reporting group title

PCV13 Group

Reporting group description

Subjects received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.

Reporting group title

ACWY2d Group

Reporting group description

Subjects received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.

Serious adverse events	ACWY1d Group	Co-ad Group	PCV13 Group	ACWY2d Group
Total subjects affected by serious adverse events
subjects affected / exposed	12 / 203 (5.91%)	13 / 201 (6.47%)	16 / 201 (7.96%)	11 / 197 (5.58%)
number of deaths (all causes)	0	1	1	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Burns first degree
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Burns second degree
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Concussion
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Petroleum distillate poisoning
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Soft tissue injury
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Febrile convulsion
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Iron deficiency anaemia
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic shock
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Asphyxia
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Aspiration
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Asthma
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	1 / 201 (0.50%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	0 / 203 (0.00%)	2 / 201 (1.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis allergic
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Abscess limb
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	1 / 203 (0.49%)	1 / 201 (0.50%)	0 / 201 (0.00%)	2 / 197 (1.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 203 (0.49%)	2 / 201 (1.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Croup infectious
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	2 / 197 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis rotavirus
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis aseptic
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Myringitis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nasopharyngitis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 203 (0.49%)	3 / 201 (1.49%)	1 / 201 (0.50%)	3 / 197 (1.52%)
occurrences causally related to treatment / all	0 / 1	1 / 3	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia pneumococcal
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal scalded skin syndrome
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	1 / 197 (0.51%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	0 / 203 (0.00%)	3 / 201 (1.49%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Marasmus
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	ACWY1d Group	Co-ad Group	PCV13 Group	ACWY2d Group
Total subjects affected by non serious adverse events
subjects affected / exposed	199 / 203 (98.03%)	197 / 201 (98.01%)	197 / 201 (98.01%)	196 / 197 (99.49%)
General disorders and administration site conditions
Crying
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Fatigue
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	1	0	1	0
Gait disturbance
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Influenza like illness
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	1 / 197 (0.51%)
occurrences all number	0	0	2	1
Injection site bruising
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Injection site mass
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	0 / 197 (0.00%)
occurrences all number	0	0	2	0
Malaise
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Pyrexia
subjects affected / exposed	12 / 203 (5.91%)	12 / 201 (5.97%)	13 / 201 (6.47%)	19 / 197 (9.64%)
occurrences all number	12	12	13	19
Swelling face
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Vaccination site bruising
subjects affected / exposed	1 / 203 (0.49%)	1 / 201 (0.50%)	2 / 201 (1.00%)	1 / 197 (0.51%)
occurrences all number	1	1	2	1
Vaccination site pain
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Pain
Additional description: Number of subjects evaluable for this local reaction.
alternative assessment type: Systematic
subjects affected / exposed ^[1]	52 / 199 (26.13%)	94 / 197 (47.72%)	91 / 197 (46.19%)	91 / 196 (46.43%)
occurrences all number	52	94	91	91
Redness
Additional description: Number of subjects evaluable for this local reaction.
alternative assessment type: Systematic
subjects affected / exposed ^[2]	68 / 199 (34.17%)	94 / 197 (47.72%)	108 / 197 (54.82%)	88 / 196 (44.90%)
occurrences all number	68	94	108	88
Swelling
Additional description: Number of subjects evaluable for this local reaction.
alternative assessment type: Systematic
subjects affected / exposed ^[3]	35 / 199 (17.59%)	75 / 197 (38.07%)	73 / 197 (37.06%)	57 / 196 (29.08%)
occurrences all number	35	75	73	57
Drowsiness
Additional description: Number of subjects evaluable for this general reaction.
alternative assessment type: Systematic
subjects affected / exposed ^[4]	62 / 199 (31.16%)	85 / 197 (43.15%)	89 / 197 (45.18%)	99 / 196 (50.51%)
occurrences all number	62	85	89	99
Irritability/Fussiness
Additional description: Number of subjects evaluable for this general reaction.
alternative assessment type: Systematic
subjects affected / exposed ^[5]	89 / 199 (44.72%)	107 / 197 (54.31%)	108 / 197 (54.82%)	116 / 196 (59.18%)
occurrences all number	89	107	108	116
Loss Of Appetite
Additional description: Number of subjects evaluable for this general reaction.
alternative assessment type: Systematic
subjects affected / exposed ^[6]	56 / 199 (28.14%)	54 / 197 (27.41%)	83 / 197 (42.13%)	78 / 196 (39.80%)
occurrences all number	56	54	83	78
Temperature/(Rectal) (°C)
Additional description: Number of subjects evaluable for this general reaction.
alternative assessment type: Systematic
subjects affected / exposed ^[7]	26 / 199 (13.07%)	34 / 197 (17.26%)	63 / 197 (31.98%)	46 / 196 (23.47%)
occurrences all number	26	34	63	46
Immune system disorders
Food allergy
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	1	0	0	1
Hypersensitivity
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Immunisation reaction
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Reproductive system and breast disorders
Balanoposthitis
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Genital labial adhesions
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	1	0	0	1
Genital rash
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Vulvovaginal adhesion
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Vulvovaginal pruritus
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	2 / 203 (0.99%)	0 / 201 (0.00%)	1 / 201 (0.50%)	2 / 197 (1.02%)
occurrences all number	2	0	1	2
Catarrh
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Cough
subjects affected / exposed	13 / 203 (6.40%)	8 / 201 (3.98%)	12 / 201 (5.97%)	21 / 197 (10.66%)
occurrences all number	13	8	12	21
Epistaxis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Nasal congestion
subjects affected / exposed	0 / 203 (0.00%)	2 / 201 (1.00%)	6 / 201 (2.99%)	4 / 197 (2.03%)
occurrences all number	0	2	6	4
Nasal disorder
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Nasal mucosal discolouration
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Productive cough
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	1 / 197 (0.51%)
occurrences all number	0	0	2	1
Respiratory disorder
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Respiratory symptom
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Rhinorrhoea
subjects affected / exposed	6 / 203 (2.96%)	6 / 201 (2.99%)	7 / 201 (3.48%)	7 / 197 (3.55%)
occurrences all number	6	6	7	7
Wheezing
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	0 / 197 (0.00%)
occurrences all number	0	0	2	0
Psychiatric disorders
Autism spectrum disorder
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Fear
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Initial insomnia
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Insomnia
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Irritability
subjects affected / exposed	0 / 203 (0.00%)	5 / 201 (2.49%)	3 / 201 (1.49%)	6 / 197 (3.05%)
occurrences all number	0	5	3	0
Sleep disorder
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	3 / 197 (1.52%)
occurrences all number	0	0	0	3
Investigations
Body temperature
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Body temperature increased
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	2 / 201 (1.00%)	1 / 197 (0.51%)
occurrences all number	1	0	2	1
Injury, poisoning and procedural complications
Burns second degree
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Contusion
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Fall
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	2 / 197 (1.02%)
occurrences all number	0	0	0	2
Head injury
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	2 / 197 (1.02%)
occurrences all number	0	0	0	2
Limb injury
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Skin abrasion
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Skin laceration
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	1 / 201 (0.50%)	1 / 197 (0.51%)
occurrences all number	1	0	1	1
Soft tissue injury
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Thermal burn
subjects affected / exposed	1 / 203 (0.49%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	1	0	0
Tibia fracture
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Wound
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Nervous system disorders
Balance disorder
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Dizziness
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Febrile convulsion
subjects affected / exposed	3 / 203 (1.48%)	0 / 201 (0.00%)	1 / 201 (0.50%)	1 / 197 (0.51%)
occurrences all number	3	0	1	1
Poor quality sleep
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Seizure
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	1	0	1	0
Somnolence
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 203 (0.49%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	1	0	0
Ear and labyrinth disorders
Ear disorder
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Eye disorders
Corneal erosion
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Eye inflammation
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Ocular hyperaemia
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Abdominal pain upper
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Abnormal faeces
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Aphthous ulcer
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	1 / 201 (0.50%)	1 / 197 (0.51%)
occurrences all number	1	0	1	1
Coeliac disease
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Constipation
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	1 / 197 (0.51%)
occurrences all number	0	0	1	1
Diarrhoea
subjects affected / exposed	7 / 203 (3.45%)	9 / 201 (4.48%)	23 / 201 (11.44%)	14 / 197 (7.11%)
occurrences all number	7	9	23	14
Dyspepsia
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Enteritis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	1 / 197 (0.51%)
occurrences all number	0	0	1	1
Faeces soft
subjects affected / exposed	1 / 203 (0.49%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	1	0	0
Gastritis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Mouth ulceration
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Nausea
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	1 / 201 (0.50%)	1 / 197 (0.51%)
occurrences all number	1	0	1	1
Stomatitis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	1 / 197 (0.51%)
occurrences all number	0	0	2	1
Teething
subjects affected / exposed	7 / 203 (3.45%)	12 / 201 (5.97%)	18 / 201 (8.96%)	14 / 197 (7.11%)
occurrences all number	7	12	18	14
Tooth disorder
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Toothache
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	1	0	0	1
Vomiting
subjects affected / exposed	6 / 203 (2.96%)	4 / 201 (1.99%)	7 / 201 (3.48%)	17 / 197 (8.63%)
occurrences all number	6	4	7	17
Skin and subcutaneous tissue disorders
Dermatitis allergic
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	1 / 197 (0.51%)
occurrences all number	0	0	2	1
Dermatitis contact
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	0 / 197 (0.00%)
occurrences all number	0	0	2	0
Dermatitis diaper
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	5 / 201 (2.49%)	5 / 197 (2.54%)
occurrences all number	0	0	5	5
Eczema
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	5 / 201 (2.49%)	4 / 197 (2.03%)
occurrences all number	1	0	5	4
Intertrigo
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Miliaria
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Petechiae
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Rash
subjects affected / exposed	5 / 203 (2.46%)	5 / 201 (2.49%)	4 / 201 (1.99%)	9 / 197 (4.57%)
occurrences all number	5	5	4	9
Rash erythematous
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	1 / 197 (0.51%)
occurrences all number	0	0	2	1
Rash macular
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	2 / 201 (1.00%)	0 / 197 (0.00%)
occurrences all number	1	0	2	0
Rash maculo-papular
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Rash morbilliform
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Skin lesion
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Urticaria
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Infections and infestations
Bronchiolitis
subjects affected / exposed	1 / 203 (0.49%)	2 / 201 (1.00%)	7 / 201 (3.48%)	3 / 197 (1.52%)
occurrences all number	1	2	7	3
Bronchitis
subjects affected / exposed	2 / 203 (0.99%)	1 / 201 (0.50%)	4 / 201 (1.99%)	3 / 197 (1.52%)
occurrences all number	2	1	4	3
Conjunctivitis
subjects affected / exposed	2 / 203 (0.99%)	4 / 201 (1.99%)	9 / 201 (4.48%)	9 / 197 (4.57%)
occurrences all number	2	4	9	9
Coxsackie viral infection
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	1 / 201 (0.50%)	2 / 197 (1.02%)
occurrences all number	1	0	1	2
Croup infectious
subjects affected / exposed	0 / 203 (0.00%)	2 / 201 (1.00%)	3 / 201 (1.49%)	3 / 197 (1.52%)
occurrences all number	0	2	3	3
Cystitis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Dermatitis infected
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Ear infection
subjects affected / exposed	1 / 203 (0.49%)	1 / 201 (0.50%)	3 / 201 (1.49%)	6 / 197 (3.05%)
occurrences all number	1	1	3	6
Erythema infectiosum
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	1	0	0	1
Exanthema subitum
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	0 / 197 (0.00%)
occurrences all number	0	0	2	0
Eye infection
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Eyelid infection
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Fungal infection
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Fungal skin infection
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	2 / 197 (1.02%)
occurrences all number	0	0	0	2
Gastroenteritis
subjects affected / exposed	1 / 203 (0.49%)	2 / 201 (1.00%)	6 / 201 (2.99%)	4 / 197 (2.03%)
occurrences all number	1	2	6	4
Gastrointestinal bacterial infection
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Hand-foot-and-mouth disease
subjects affected / exposed	1 / 203 (0.49%)	6 / 201 (2.99%)	4 / 201 (1.99%)	4 / 197 (2.03%)
occurrences all number	1	6	4	4
Herpangina
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Hordeolum
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Impetigo
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	2 / 197 (1.02%)
occurrences all number	0	0	1	2
Infected bite
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Influenza
subjects affected / exposed	1 / 203 (0.49%)	4 / 201 (1.99%)	2 / 201 (1.00%)	0 / 197 (0.00%)
occurrences all number	1	4	2	0
Laryngitis
subjects affected / exposed	1 / 203 (0.49%)	1 / 201 (0.50%)	2 / 201 (1.00%)	1 / 197 (0.51%)
occurrences all number	1	1	2	1
Lower respiratory tract infection
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	2 / 201 (1.00%)	1 / 197 (0.51%)
occurrences all number	1	0	2	1
Measles
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Nasopharyngitis
subjects affected / exposed	9 / 203 (4.43%)	11 / 201 (5.47%)	15 / 201 (7.46%)	17 / 197 (8.63%)
occurrences all number	9	11	15	17
Oral candidiasis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Otitis media
subjects affected / exposed	3 / 203 (1.48%)	4 / 201 (1.99%)	11 / 201 (5.47%)	8 / 197 (4.06%)
occurrences all number	3	4	11	8
Otitis media acute
subjects affected / exposed	0 / 203 (0.00%)	1 / 201 (0.50%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	0	1	0	0
Otosalpingitis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Periodontitis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Periorbital cellulitis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Pharyngitis
subjects affected / exposed	3 / 203 (1.48%)	2 / 201 (1.00%)	2 / 201 (1.00%)	3 / 197 (1.52%)
occurrences all number	3	2	2	3
Pharyngotonsillitis
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Pneumonia
subjects affected / exposed	1 / 203 (0.49%)	2 / 201 (1.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	1	2	1	0
Pulmonary tuberculosis
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Respiratory tract infection
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	1	0	0	1
Rhinitis
subjects affected / exposed	4 / 203 (1.97%)	3 / 201 (1.49%)	4 / 201 (1.99%)	5 / 197 (2.54%)
occurrences all number	4	3	4	5
Roseola
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	2 / 201 (1.00%)	0 / 197 (0.00%)
occurrences all number	0	0	2	0
Sinusitis
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Skin bacterial infection
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Staphylococcal infection
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1
Tinea infection
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Tinea versicolour
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	1 / 201 (0.50%)	0 / 197 (0.00%)
occurrences all number	0	0	1	0
Tonsillitis
subjects affected / exposed	2 / 203 (0.99%)	1 / 201 (0.50%)	2 / 201 (1.00%)	5 / 197 (2.54%)
occurrences all number	2	1	2	5
Upper respiratory tract infection
subjects affected / exposed	12 / 203 (5.91%)	15 / 201 (7.46%)	24 / 201 (11.94%)	28 / 197 (14.21%)
occurrences all number	12	15	24	28
Urinary tract infection
subjects affected / exposed	1 / 203 (0.49%)	0 / 201 (0.00%)	0 / 201 (0.00%)	0 / 197 (0.00%)
occurrences all number	1	0	0	0
Varicella
subjects affected / exposed	2 / 203 (0.99%)	1 / 201 (0.50%)	2 / 201 (1.00%)	4 / 197 (2.03%)
occurrences all number	2	1	2	4
Viral infection
subjects affected / exposed	6 / 203 (2.96%)	4 / 201 (1.99%)	7 / 201 (3.48%)	12 / 197 (6.09%)
occurrences all number	6	4	7	12
Viral rash
subjects affected / exposed	1 / 203 (0.49%)	1 / 201 (0.50%)	1 / 201 (0.50%)	2 / 197 (1.02%)
occurrences all number	1	1	1	2
Viral upper respiratory tract infection
subjects affected / exposed	3 / 203 (1.48%)	1 / 201 (0.50%)	1 / 201 (0.50%)	4 / 197 (2.03%)
occurrences all number	3	1	1	4
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	3 / 203 (1.48%)	1 / 201 (0.50%)	1 / 201 (0.50%)	4 / 197 (2.03%)
occurrences all number	3	1	1	4
Polydipsia
subjects affected / exposed	0 / 203 (0.00%)	0 / 201 (0.00%)	0 / 201 (0.00%)	1 / 197 (0.51%)
occurrences all number	0	0	0	1

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of subjects exposed here are for this particular local/systemic event and is different from total number of subjects exposed for any adverse event.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of subjects exposed here are for this particular local/systemic event and is different from total number of subjects exposed for any adverse event.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of subjects exposed here are for this particular local/systemic event and is different from total number of subjects exposed for any adverse event.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of subjects exposed here are for this particular local/systemic event and is different from total number of subjects exposed for any adverse event.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of subjects exposed here are for this particular local/systemic event and is different from total number of subjects exposed for any adverse event.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of subjects exposed here are for this particular local/systemic event and is different from total number of subjects exposed for any adverse event.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of subjects exposed here are for this particular local/systemic event and is different from total number of subjects exposed for any adverse event.

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Were there any global substantial amendments to the protocol? Yes

25 Jan 2016

Sections updated/added in line with standard Pfizer policy: Section 8.1.2 Definition of an adverse event. Section 8.2 Detecting and recording adverse events, serious adverse events, new onset of chronic illnesses (NOCIs), and Guillain-Barre syndrome (GBS). Section 11.7 Reporting of safety issues and serious breaches of the protocol or ICH GCP.

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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups

Primary: Percentage of Subjects With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups

Primary: Percentage of Subjects With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

Primary: Percentage of Subjects With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

Primary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups

Primary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups

Primary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups

Primary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups

Primary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups

Primary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups

Primary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups

Primary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups

Primary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups

Primary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups

Primary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups

Primary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups

Primary: Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

Primary: Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

Secondary: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups

Secondary: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups

Secondary: Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

Secondary: Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

Secondary: Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups

Secondary: Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups

Secondary: Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

Secondary: Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

Secondary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group

Secondary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group

Secondary: Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group

Secondary: Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group

Secondary: Percentage of Subjects With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups

Secondary: Percentage of Subjects With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups

Secondary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups

Secondary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups

Secondary: Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups

Secondary: Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups

Secondary: Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups

Secondary: Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups

Secondary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups

Secondary: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups

Secondary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups

Secondary: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups

Secondary: Percentage of Subjects With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

Secondary: Percentage of Subjects With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

Secondary: Percentage of Subjects With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

Secondary: Percentage of Subjects With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

Secondary: Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

Secondary: Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

Secondary: Number of Subjects With Solicited Local Reactions Within 4 Days Post Each Vaccination

Secondary: Number of Subjects With Solicited Local Reactions Within 4 Days Post Each Vaccination

Secondary: Number of Subjects With Solicited General Reactions Within 4 Days Post Each Vaccination

Secondary: Number of Subjects With Solicited General Reactions Within 4 Days Post Each Vaccination

Secondary: Number of Subjects With Unsolicited Adverse Events Within 31 Days Post any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)

Secondary: Number of Subjects With Unsolicited Adverse Events Within 31 Days Post any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)

Secondary: Number of Subjects With Serious Adverse Events from Month 0 to Month 9

Secondary: Number of Subjects With Serious Adverse Events from Month 0 to Month 9

Secondary: Number of Subjects With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study

Secondary: Number of Subjects With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study

Secondary: Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs) from Month 0 to Month 9

Secondary: Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs) from Month 0 to Month 9

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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