Clinical Trial Results:
A Phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of four different formulations of GlaxoSmithKline (GSK) Biologicals’ new generations meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine versus MENINGITEC™ or MENCEVAX™ ACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old.

Due to a system error, the data reported in v1 is not correct and has been removed from public view.

Summary
EudraCT number	2005-001288-73
Trial protocol	AT DE
Global end of trial date	13 Feb 2008

Results information
Results version number	v2(current)
This version publication date	10 Jun 2016
First version publication date	05 Jun 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set Data correction due to a system error in EudraCT – Results.

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

104703, 104704

ISRCTN number

US NCT number

NCT00126984

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.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

Interim

Date of interim/final analysis

13 Apr 2007

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Feb 2008

Was the trial ended prematurely?

Main objective of the trial

Based on the immune response induced one month post vaccination, to select the best of four different formulations of GSK Biologicals’ new generations MenACWY-TT conjugate vaccine when given as one single dose to healthy children aged 12-14 months and 3-5 years.

Protection of trial subjects

Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.

Background therapy

Evidence for comparator

Actual start date of recruitment

26 Jul 2005

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy

Long term follow-up duration

16 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Austria: 110

Country: Number of subjects enrolled

Germany: 398

Worldwide total number of subjects

508

EEA total number of subjects

508

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)

240

Children (2-11 years)

268

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

Screening details

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Period 1 title

Primary study

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject

Blinding implementation details

The 4 different formulations of MenACWY-TT vaccine were administered in a double-blind manner, while the control vaccines, MenC and MenACWY were given to the subjects in an open manner.

Are arms mutually exclusive

Yes

12-14 months of age Formulation 1 Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix™

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of Nimenrix™ vaccine Formulation 1 at Day 0, intramuscularly in the left deltoid.

Investigational medicinal product name

DTPa/Hib

Investigational medicinal product code

Other name

GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis vaccine mixed with Haemophilus influenzae type

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 booster dose 1 months after the administration of Nimenrix, injected intramuscularly into the left anterolateral thigh or into the left deltoid according to local requirements.

12-14 months of age Formulation 2 Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix™

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of Nimenrix™ vaccine Formulation 2 at Day 0, intramuscularly in the left deltoid.

Investigational medicinal product name

DTPa/Hib

Investigational medicinal product code

Other name

GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis vaccine mixed with Haemophilus influenzae type

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 booster dose 1 months after the administration of Nimenrix, injected intramuscularly into the left anterolateral thigh or into the left deltoid according to local requirements.

12-14 months of age Formulation 3 Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix™

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of Nimenrix™ vaccine Formulation 3 at Day 0, intramuscularly in the left deltoid.

Investigational medicinal product name

DTPa/Hib

Investigational medicinal product code

Other name

GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis vaccine mixed with Haemophilus influenzae type

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 booster dose 1 months after the administration of Nimenrix, injected intramuscularly into the left anterolateral thigh or into the left deltoid according to local requirements.

12-14 months of age Formulation 4 Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix™

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of Nimenrix™ vaccine Formulation 4 at Day 0, intramuscularly in the left deltoid.

Investigational medicinal product name

DTPa/Hib

Investigational medicinal product code

Other name

GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis vaccine mixed with Haemophilus influenzae type

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 booster dose 1 months after the administration of Nimenrix, injected intramuscularly into the left anterolateral thigh or into the left deltoid according to local requirements.

12-14 months of age Control Group

Arm description

Arm type

Active comparator

Investigational medicinal product name

Meningitec™

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of Meningitec™ at Day 0, intramuscularly into the left deltoid.

Investigational medicinal product name

DTPa/Hib

Investigational medicinal product code

Other name

GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis vaccine mixed with Haemophilus influenzae type

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 booster dose 1 months after the administration of Nimenrix, injected intramuscularly into the left anterolateral thigh or into the left deltoid according to local requirements.

3-5 years of age Formulation 1 Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix™

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of Nimenrix™ vaccine Formulation 1 at Day 0.

3-5 years of age Formulation 2 Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix™

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of Nimenrix™ vaccine Formulation 2 at Day 0.

3-5 years of age Formulation 3 Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix™

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of Nimenrix™ vaccine Formulation 3 at Day 0.

3-5 years of age Formulation 4 Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix™

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of Nimenrix™ vaccine Formulation 4 at Day 0.

3-5 years of age Control Group

Arm description

Arm type

Active comparator

Investigational medicinal product name

Meningitec™

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of Meningitec™ at Day 0.

Number of subjects in period 1	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Started	48	48	48	48	48	54	53	54	54	53
Completed at Visit 2	0 ^[1]	0 ^[2]	0 ^[3]	0 ^[4]	0 ^[5]	53	53	54	54	53
Completed at Visit 3	48	45	48	47	47	0 ^[6]	0 ^[7]	0 ^[8]	0 ^[9]	0 ^[10]
Completed	48	45	48	47	47	53	53	54	54	53
Not completed	0	3	0	1	1	1	0	0	0	0
Other	-	3	-	1	1	1	-	-	-	-

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The children (3-5 years) groups completed the study at Visit 2, while the toddlers (12-14 months) groups completed it at Visit 3.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The children (3-5 years) groups completed the study at Visit 2, while the toddlers (12-14 months) groups completed it at Visit 3.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The children (3-5 years) groups completed the study at Visit 2, while the toddlers (12-14 months) groups completed it at Visit 3.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The children (3-5 years) groups completed the study at Visit 2, while the toddlers (12-14 months) groups completed it at Visit 3.
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The children (3-5 years) groups completed the study at Visit 2, while the toddlers (12-14 months) groups completed it at Visit 3.
[6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The children (3-5 years) groups completed the study at Visit 2, while the toddlers (12-14 months) groups completed it at Visit 3.
[7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The children (3-5 years) groups completed the study at Visit 2, while the toddlers (12-14 months) groups completed it at Visit 3.
[8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The children (3-5 years) groups completed the study at Visit 2, while the toddlers (12-14 months) groups completed it at Visit 3.
[9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The children (3-5 years) groups completed the study at Visit 2, while the toddlers (12-14 months) groups completed it at Visit 3.
[10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The children (3-5 years) groups completed the study at Visit 2, while the toddlers (12-14 months) groups completed it at Visit 3.

Period 2 title

Persistence/challenge study

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

12-14 months of age Challenge Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Mencevax™ ACWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1/5 of a dose of Mencevax™ ACWY at Month 15

12-14 months of age Control Group

Arm description

Arm type

Active comparator

Investigational medicinal product name

Mencevax™ ACWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

The subjects in the toddler age stratum vaccinated with the selected MenACWY-TT formulation or with the control vaccine were given 1/5 of a dose of MenACWY at Month 15. MenACWY-TT vaccines were administered intramuscularly in the left deltoid.

3-5 years of age Challenge Group

Arm description

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

3-5 years of age Control Group

Arm description

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 2 ^[11]	12-14 months of age Challenge Group	12-14 months of age Control Group	3-5 years of age Challenge Group	3-5 years of age Control Group
Started	42	43	50	50
Completed	42	42	50	50
Not completed	0	1	0	0
Other	-	1	-	-

Notes
[11] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Subjects not returning for a specific visit were not withdrawn and could participate in the subsequent follow-up phase. Actual enrollment differed depending on the rate of return for the follow-up phase, so not all enrolled subjects came to each visit.

Baseline characteristics

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Reporting group title

12-14 months of age Formulation 1 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 2 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 3 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 4 Group

Reporting group description

Reporting group title

12-14 months of age Control Group

Reporting group description

Reporting group title

3-5 years of age Formulation 1 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 2 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 3 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 4 Group

Reporting group description

Reporting group title

3-5 years of age Control Group

Reporting group description

Reporting group values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group	Total
Number of subjects	48	48	48	48	48	54	53	54	54	53	508
Age categorical
Units: Subjects
In utero											0
Preterm newborn infants (gestational age < 37 wks)											0
Newborns (0-27 days)											0
Infants and toddlers (28 days-23 months)											0
Children (2-11 years)											0
Adolescents (12-17 years)											0
Adults (18-64 years)											0
From 65-84 years											0
85 years and over											0
Age continuous
Units: months
arithmetic mean (standard deviation)	12.6 ( 0.79 )	12.5 ( 0.8 )	12.7 ( 0.84 )	12.4 ( 0.71 )	12.6 ( 0.77 )	47.1 ( 7.7 )	45.9 ( 7.93 )	47.4 ( 6.91 )	46.7 ( 6.66 )	47.8 ( 7.47 )	-
Gender categorical
Units: Subjects
Female	20	25	25	29	27	18	27	29	27	28	255
Male	28	23	23	19	21	36	26	25	27	25	253

End points

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Reporting group title

12-14 months of age Formulation 1 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 2 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 3 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 4 Group

Reporting group description

Reporting group title

12-14 months of age Control Group

Reporting group description

Reporting group title

3-5 years of age Formulation 1 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 2 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 3 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 4 Group

Reporting group description

Reporting group title

3-5 years of age Control Group

Reporting group description

Reporting group title

12-14 months of age Challenge Group

Reporting group description

Reporting group title

12-14 months of age Control Group

Reporting group description

Reporting group title

3-5 years of age Challenge Group

Reporting group description

Reporting group title

3-5 years of age Control Group

Reporting group description

Primary: Number of subjects with an immune response to the serum bactericidal assay meningococcal serogroup A using rabbit complement (rSBA-MenA), rSBA-MenC, rSBA-MenW-135, rSBA-MenY

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End point title

Number of subjects with an immune response to the serum bactericidal assay meningococcal serogroup A using rabbit complement (rSBA-MenA), rSBA-MenC, rSBA-MenW-135, rSBA-MenY ^[1]

End point description

End point type

Primary

End point timeframe

One month after primary vaccination.

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: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	43	41	42	41	45	47	47	48	50	34
Units: Subjects
rSBA-MenA (N=36,35,36,35,31,34,37,40,36,31)	36	35	35	34	3	31	34	37	36	25
rSBA-MenC (N=43,40,41,41,45,47,47,47,49,32)	42	39	40	39	41	46	46	44	43	26
rSBA-MenW-135 (N=43,41,42,40,44,47,47,47,49,32)	43	39	41	40	6	46	47	47	43	31
rSBA-MenY (N=43,41,40,41,44,46,47,48,50,34)	42	40	35	39	5	43	42	48	49	27

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	44	41	43	42	46	48	48	49	50	34
Units: Subjects
rSBA-MenA, PRE (N=37,35,37,35,37,34,39,40,36,31)	10	13	19	18	7	30	38	32	31	22
rSBA-MenA, M1 (N=44,41,42,42,39,48,46,49,50,33)	44	41	42	42	14	48	46	49	50	33
rSBA-MenC, PRE (N=44,40,42,41,45,47,47,47,49,32)	7	9	3	4	4	11	11	11	10	11
rSBA-MenC, M1 (N=44,41,42,42,46,48,48,49,50,34)	43	41	42	42	45	48	48	49	50	33
rSBA-MenW-135,PRE(N=44,41,42,40,45,47,47,47,45,32)	17	8	15	13	14	27	25	24	20	17
rSBA-MenW-135,M1 (N=44,41,43,42,45,48,48,49,50,34)	44	41	43	42	15	47	48	49	50	34
rSBA-MenY, PRE (N=44,41,41,41,45,46,47,48,50,34)	24	16	24	20	20	33	29	33	30	22
rSBA-MenY, M1 (N=44,41,42,42,45,48,48,49,50,34)	44	41	42	42	21	48	48	49	50	34

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	44	41	43	42	46	48	48	49	50	45
Units: Subjects
rSBA-MenA, PRE (N=37,35,37,35,37,34,39,40,36,31)	6	10	18	16	7	26	38	32	30	22
rSBA-MenA, M1 (N=44,41,42,42,39,48,46,49,50,33)	44	41	42	42	14	48	46	49	50	33
rSBA-MenC, PRE (N=44,40,42,41,45,47,47,47,49,32)	2	2	1	3	1	4	5	9	7	6
rSBA-MenC, M1 (N=44,41,42,42,46,48,48,49,50,34)	40	38	40	37	40	47	48	48	48	30
rSBA-MenW-135,PRE (N=44,41,42,40,45,47,47,47,45,32	3	3	4	5	5	9	14	12	13	8
rSBA-MenW-135,M1 (N=44,41,43,42,45,48,48,49,50,34)	44	41	43	42	10	47	48	49	50	34
rSBA-MenY, PRE (N=44,41,41,41,45,46,47,48,50,34)	12	12	14	11	10	21	22	25	22	17
rSBA-MenY, M1(N=44,41,42,42,45,48,48,49,50,34)	44	40	42	42	15	48	48	49	50	33

No statistical analyses for this end point

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

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End point title

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	44	41	43	42	46	48	48	49	50	45
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA, PRE (N=37,35,37,35,37,34,39,40,36,31)	11.2 (6.2 to 20.1)	17.1 (8.5 to 34.5)	44.1 (19.5 to 99.6)	41.2 (18.2 to 93)	9.1 (5.1 to 16.3)	236.6 (129.6 to 432.2)	441.3 (317.6 to 613.2)	192.8 (100.1 to 371.4)	277.2 (147 to 522.7)	139 (56.7 to 341.1)
rSBA-MenA, M1 (N=44,41,42,42,39,48,46,49,50,33)	4050.6 (3087.4 to 5314.3)	6060.2 (4447 to 8258.6)	5665.2 (4086 to 7854.9)	4859.8 (3488.7 to 6769.8)	20.5 (9.7 to 43.3)	7223.8 (5905 to 8837.1)	9287.4 (7177.6 to 12017.4)	8299.4 (6734.2 to 10228.4)	9980.3 (8019.4 to 12420.7)	3798.4 (2888.9 to 4994.2)
rSBA-MenC, PRE (N=44,40,42,41,45,47,47,47,49,32)	6.4 (4.6 to 8.9)	7.8 (5.2 to 11.9)	5.4 (3.8 to 7.8)	6 (4 to 9)	5.3 (4 to 7)	8.2 (5.4 to 12.4)	8.8 (5.5 to 13.9)	10.1 (6.1 to 16.9)	9.3 (5.5 to 15.6)	14.1 (7.1 to 28.1)
rSBA-MenC, M1 (N=44,41,42,42,46,48,48,49,50,34)	536.8 (365.8 to 787.7)	1075.3 (744.4 to 1553.2)	983.5 (718.7 to 1345.9)	543.9 (380.9 to 776.8)	372.5 (257.7 to 538.4)	1325.4 (954.9 to 1839.7)	1951.1 (1402 to 2715.1)	1577.8 (1123.5 to 2215.9)	1495.8 (1093.4 to 2046.3)	445.4 (263.3 to 753.3)
rSBA-MenW-135,PRE (N=44,41,42,40,45,47,47,47,45,32	12.6 (7.8 to 20.3)	7.9 (5 to 12.4)	12 (7.4 to 19.4)	11.4 (6.9 to 18.9)	10.8 (6.7 to 17.4)	25.2 (15.4 to 41.4)	27.7 (15.6 to 49.3)	22.9 (13.3 to 39.4)	20.8 (11.6 to 37.4)	24.4 (12.6 to 47.2)
rSBA-MenW-135,M1 (N=44,41,43,42,45,48,48,49,50,34)	3389.6 (2581.6 to 4450.4)	2665.9 (1985.9 to 3578.8)	3975.2 (3065.7 to 5154.5)	3240.7 (2375.9 to 4420.4)	14.6 (8 to 26.6)	4736.7 (3302 to 6794.9)	6400.6 (5037.9 to 8132)	5987.2 (4846.9 to 7395.7)	7123.1 (5960.2 to 8512.9)	1811.1 (1233.3 to 2659.5)
rSBA-MenY, PRE (N=44,41,41,41,45,46,47,48,50,34)	27 (15.1 to 48.3)	19.4 (10 to 37.7)	42.1 (21.2 to 83.8)	23.9 (12.5 to 46)	21 (11.3 to 39)	73.1 (38.8 to 137.5)	62.8 (31.4 to 125.4)	80.3 (42.5 to 151.7)	52.3 (27.2 to 100.4)	61 (27.5 to 135.2)
rSBA-MenY, M1(N=44,41,42,42,45,48,48,49,50,34)	2010.3 (1458.8 to 2770.3)	2196.3 (1510 to 3194.5)	2295.1 (1701.5 to 3095.8)	2006.5 (1477 to 2725.9)	27.8 (14 to 55.3)	4456.2 (3489.7 to 5690.4)	4670.4 (3541.9 to 6158.4)	6433 (4921 to 8409.6)	6042.4 (4720.2 to 7734.9)	1435.5 (972.6 to 2118.7)

No statistical analyses for this end point

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

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End point title

Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	46	40	43	41	45	48	46	49	50	34
Units: Subjects
Anti-PSA, PRE (N=43,36,37,38,43,42,42,46,46,30)	1	3	2	0	2	7	8	6	7	5
Anti-PSC, PRE (N=43,36,38,41,43,44,43,47,47,30)	0	1	0	1	2	2	0	2	4	5
Anti-PSW-135, PRE(N=39,35,35,37,39,42,41,44,47,29)	1	2	0	0	0	1	1	0	1	0
Anti-PSY, PRE (N=42,38,39,40,42,45,45,45,49,31)	2	0	0	2	1	0	1	1	3	2
Anti-PSA, M1 (N=46,39,43,40,43,48,47,49,49,34)	46	39	43	40	3	47	47	49	49	34
Anti-PSC, M1 (N=46,40,43,41,45,46,47,49,50,34)	46	40	43	41	44	46	47	49	50	34
Anti-PSW-135, M1 (N=44,38,40,39,40,44,45,48,48,33)	43	37	40	39	0	43	44	48	48	33
Anti-PSY, M1 (N=44,40,39,41,42,47,46,49,49,34)	43	39	39	41	3	46	46	49	49	34

No statistical analyses for this end point

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

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End point title

Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	46	40	43	41	45	48	47	49	50	34
Units: Subjects
Anti-PSA, PRE (N=43,36,37,38,43,42,42,46,46,30)	0	0	0	0	0	2	3	2	3	1
Anti-PSC, PRE (N=43,36,38,41,43,44,43,47,47,30)	0	1	0	0	0	1	0	1	2	1
Anti-PSW-135, PRE(N=39,35,35,37,39,42,41,44,47,29)	0	0	0	0	0	0	0	0	1	0
Anti-PSY, PRE (N=42,38,39,40,42,45,45,45,49,31)	0	0	0	0	0	0	0	0	1	1
Anti-PSA, M1 (N=46,39,43,40,43,48,47,49,49,34)	45	39	43	40	1	45	47	49	49	32
Anti-PSC, M1 (N=46,40,43,41,45,46,47,49,50,34)	45	40	42	41	42	42	47	49	50	33
Anti-PSW-135, M1 (N=44,38,40,39,40,44,45,48,48,33)	31	28	36	36	0	31	29	39	45	28
Anti-PSY, M1 (N=44,40,39,41,42,47,46,49,49,34)	36	35	37	40	1	39	40	44	48	33

No statistical analyses for this end point

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

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End point title

Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	46	40	40	41	45	48	47	49	50	34
Units: μg/mL
geometric mean (confidence interval 95%)
Anti-PSA, PRE (N=43,36,37,38,43,42,42,46,46,30)	0.15 (0.15 to 0.16)	0.17 (0.14 to 0.21)	0.16 (0.14 to 0.18)	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.18)	0.2 (0.16 to 0.26)	0.24 (0.17 to 0.34)	0.19 (0.16 to 0.24)	0.22 (0.16 to 0.3)	0.2 (0.14 to 0.3)
Anti-PSC, PRE (N=43,36,38,41,43,44,43,47,47,30)	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.19)	0.15 (0.15 to 0.15)	0.15 (0.15 to 0.16)	0.17 (0.14 to 0.19)	0.16 (0.14 to 0.19)	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.19)	0.19 (0.15 to 0.24)	0.22 (0.16 to 0.3)
Anti-PSW-135, PRE(N=39,35,35,37,39,42,41,44,47,29)	0.15 (0.15 to 0.16)	0.16 (0.14 to 0.19)	0.15 (0.15 to 0.15)	0.15 (0.15 to 0.15)	0.15 (0.15 to 0.15)	0.15 (0.15 to 0.17)	0.16 (0.14 to 0.17)	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.19)	0.15 (0.15 to 0.15)
Anti-PSY, PRE (N=42,38,39,40,42,45,45,45,49,31)	0.16 (0.15 to 0.17)	0.15 (0.15 to 0.15)	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.18)	0.15 (0.15 to 0.16)	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.18)	0.15 (0.15 to 0.16)	0.17 (0.14 to 0.21)	0.17 (0.14 to 0.21)
Anti-PSA, M1 (N=46,39,43,40,43,48,47,49,49,34)	17.24 (12.8 to 23.21)	28.83 (20.85 to 39.86)	37.27 (29.31 to 47.4)	35.37 (27.39 to 45.68)	0.17 (0.14 to 0.2)	18.15 (12.2 to 27)	29.71 (22.82 to 38.68)	29.25 (22.57 to 37.9)	39.4 (30.83 to 50.36)	11.43 (7.73 to 16.89)
Anti-PSC, M1 (N=46,40,43,41,45,46,47,49,50,34)	10.49 (8.17 to 13.48)	18.88 (14.96 to 23.82)	20.66 (16.66 to 25.61)	13.26 (10.48 to 16.78)	8.01 (6.01 to 10.67)	7.43 (5.71 to 9.68)	10.81 (8.89 to 13.14)	13.12 (10.27 to 16.76)	11.09 (8.87 to 13.87)	11.44 (8.35 to 15.67)
Anti-PSW-135, M1 (N=44,38,40,39,40,44,45,48,48,33)	3.38 (2.49 to 4.57)	4.02 (2.91 to 5.56)	6.81 (5.07 to 9.14)	6.31 (4.9 to 8.13)	0.15 (0.15 to 0.15)	3.88 (2.69 to 5.58)	3.24 (2.25 to 4.65)	4.07 (3.16 to 5.23)	7.03 (5.33 to 9.27)	6.68 (4.3 to 10.38)
Anti-PSY, M1 (N=44,40,39,41,42,47,46,49,49,34)	6.64 (4.63 to 9.52)	6.12 (4.17 to 8.98)	10.89 (8.08 to 14.69)	9.61 (6.97 to 13.25)	0.18 (0.14 to 0.23)	5.48 (3.96 to 7.59)	6.52 (4.67 to 9.12)	9.15 (6.77 to 12.37)	15.06 (10.65 to 21.28)	14.07 (8.9 to 22.25)

No statistical analyses for this end point

Secondary: Number of subjects with anti-tetanus (anti-T) antibody titers ≥ 0.1 IU/mL

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End point title

Number of subjects with anti-tetanus (anti-T) antibody titers ≥ 0.1 IU/mL

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	46	41	43	42	45	48	48	49	51	34
Units: Subjects
Anti-T, PRE (N=46,41,43,42,45,46,48,48,51,33)	45	37	39	38	41	41	43	42	49	28
Anti-T, M1 (N=46,41,43,41,44,48,48,49,50,34)	46	41	43	41	39	48	48	49	50	29

No statistical analyses for this end point

Secondary: Anti-tetanus (anti-T) antibody concentrations

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End point title

Anti-tetanus (anti-T) antibody concentrations

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	46	41	43	42	45	48	48	49	51	34
Units: IU/mL
geometric mean (confidence interval 95%)
Anti-T, PRE (N=46,41,43,42,45,46,48,48,51,33)	0.622 (0.457 to 0.847)	0.555 (0.385 to 0.799)	0.428 (0.307 to 0.596)	0.366 (0.26 to 0.514)	0.464 (0.329 to 0.654)	0.581 (0.395 to 0.854)	0.659 (0.449 to 0.967)	0.47 (0.335 to 0.659)	0.465 (0.357 to 0.605)	0.363 (0.238 to 0.555)
Anti-T, M1 (N=46,41,43,41,44,48,48,49,50,34)	6.026 (4.249 to 8.546)	6.358 (4.267 to 9.474)	6.456 (4.325 to 9.638)	3.553 (2.348 to 5.378)	0.423 (0.29 to 0.618)	11.786 (8.711 to 15.947)	18.722 (13.704 to 25.576)	16.696 (12.732 to 21.894)	13.877 (10.424 to 18.474)	0.352 (0.239 to 0.52)

No statistical analyses for this end point

Secondary: Number of subjects with serum bactericidal assay using human complement (hSBA-MenA, hSBA-MenC ,hSBA-MenW-135, hSBA-MenY) titers ≥ 1:4

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End point title

Number of subjects with serum bactericidal assay using human complement (hSBA-MenA, hSBA-MenC ,hSBA-MenW-135, hSBA-MenY) titers ≥ 1:4 ^[2]

End point description

The hSBA-MenA and hSBA-MenW-135 assays were performed using 2 bacterial strains. For the hSBA-MenA assay, strains with an L10 and L11 immunotype were used. For the hSBA-MenW-135 assay, the 3193 and MP01240070 (referred to as MP) strains were used.

End point type

Secondary

End point timeframe

Prior to (PRE) and 1 month after (M1) the vaccine dose and 15 months after priming (M15)

Notes
[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: The endpoint analysis was based only on subjects of the control groups and all subjects in the group that received Nimenrix formulation 3.

End point values	12-14 months of age Formulation 3 Group	12-14 months of age Control Group	3-5 years of age Formulation 3 Group	3-5 years of age Control Group
Number of subjects analysed	36	43	38	29
Units: Subjects
hSBA-MenA L10, Pre (N=36,42,38,29)	2	3	6	4
hSBA-MenA L11, PRE (N=30,34,38,27)	0	1	0	0
hSBA-MenC, PRE (N=12,14,20,12)	1	1	5	7
hSBA-MenW-135 MP, PRE (N=34,40,34,23)	2	0	6	2
hSBA-MenW-135 3193, PRE (N=31,35,34,23)	0	0	3	1
hSBA-MenY, PRE (N=33,43,38,28)	2	4	7	7
hSBA-MenA L10, M1 (N=26,30,37,24)	24	4	31	10
hSBA-MenA L11, M1 (N=22,28,25,24)	21	1	19	7
hSBA-MenC, M1 (N=11,12,19,12)	11	10	18	11
hSBA-MenW-135 MP, M1 (N=24,28,30,16)	20	0	26	10
hSBA-MenW-135 3193, M1 (N=26,27,31,21)	15	0	18	10
hSBA-MenY, M1 (N=26,31,33,25)	20	2	30	14
hSBA-MenA, M15 (N=18,20,24,14)	4	1	5	1
hSBA-MenC, M15 (N=27,27,35,22)	26	18	33	17
hSBA-MenW-135, M15 (N=18,16,24,6)	18	0	23	2
hSBA-MenY, M15 (N=26,25,32,19)	25	3	29	12

No statistical analyses for this end point

Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers

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End point title

hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers ^[3]

End point description

End point type

Secondary

End point timeframe

Prior to and 1 month after the vaccine dose and 15 months after priming

Notes
[3] - 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: The endpoint analysis was based only on subjects of the control groups and all subjects in the group that received Nimenrix formulation 3.

End point values	12-14 months of age Formulation 3 Group	12-14 months of age Control Group	3-5 years of age Formulation 3 Group	3-5 years of age Control Group
Number of subjects analysed	36	43	38	29
Units: Titers
geometric mean (confidence interval 95%)
hSBA-MenA L10, Pre (N=36,42,38,29)	2.1 (1.9 to 2.4)	2.1 (2 to 2.3)	2.7 (2.1 to 3.4)	3.2 (2 to 5)
hSBA-MenA L11, PRE (N=30,34,38,27)	2 (2 to 2)	2.1 (1.9 to 2.2)	2 (2 to 2)	2 (2 to 2)
hSBA-MenC, PRE (N=12,14,20,12)	2.2 (1.8 to 2.7)	2.1 (1.9 to 2.5)	3.3 (2.1 to 5.1)	5.7 (2.6 to 12.4)
hSBA-MenW-135 MP, PRE (N=34,40,34,23)	2.1 (1.9 to 2.4)	2 (2 to 2)	4.9 (2.5 to 9.9)	3 (1.6 to 5.4)
hSBA-MenW-135 3193, PRE (N=31,35,34,23)	2 (2 to 2)	2 (2 to 2)	3 (1.9 to 4.6)	2.1 (1.9 to 2.4)
hSBA-MenY, PRE (N=33,43,38,28)	2.4 (1.8 to 3.2)	2.5 (1.9 to 3.1)	3.6 (2.3 to 5.6)	4 (2.4 to 6.8)
hSBA-MenA L10, M1 (N=26,30,37,24)	39 (23.2 to 65.5)	2.7 (2 to 3.7)	24.6 (15 to 40.6)	5.7 (3 to 10.8)
hSBA-MenA L11, M1 (N=22,28,25,24)	54.3 (32.7 to 90.3)	2.1 (1.9 to 2.3)	29.8 (14.4 to 61.6)	3.8 (2.3 to 6.3)
hSBA-MenC, M1 (N=11,12,19,12)	194.7 (152.4 to 248.7)	33.4 (11.6 to 96.6)	89.7 (44.5 to 180.8)	26.5 (11.4 to 61.5)
hSBA-MenW-135 MP, M1 (N=24,28,30,16)	134.6 (54.3 to 333.3)	2 (2 to 2)	247.3 (113.5 to 538.9)	53.5 (11.3 to 252.8)
hSBA-MenW-135 3193, M1 (N=26,27,31,21)	9.1 (4.9 to 17)	2 (2 to 2)	17.3 (8.3 to 36)	8 (3.7 to 17.4)
hSBA-MenY, M1 (N=26,31,33,25)	21.1 (10.4 to 42.7)	2.3 (1.9 to 2.8)	56.2 (33.8 to 93.3)	12.5 (5.8 to 26.9)
hSBA-MenA, M15 (N=18,20,24,14)	2.8 (2 to 3.9)	2.2 (1.8 to 2.6)	3.5 (2.2 to 5.7)	2.2 (1.8 to 2.7)
hSBA-MenC, M15 (N=27,27,35,22)	189.2 (111.9 to 319.9)	19.6 (9.6 to 39.9)	112.4 (70.2 to 180)	28.1 (12.9 to 61)
hSBA-MenW-135, M15 (N=18,16,24,21)	313.8 (182.6 to 539.2)	2 (2 to 2)	221.5 (136.8 to 358.7)	8.1 (0.8 to 79.7)
hSBA-MenY, M15 (N=26,25,32,19)	95.3 (56.7 to 160.4)	2.9 (1.8 to 4.6)	92.3 (48.6 to 175.1)	20.9 (7.4 to 58.9)

No statistical analyses for this end point

Secondary: Number of subjects with solicited local symptoms in children

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End point title

Number of subjects with solicited local symptoms in children ^[4]

End point description

End point type

Secondary

End point timeframe

During the 8-day (Days 0-7) post-vaccination period after each dose and overall

Notes
[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: These symptoms were only reported in children.

End point values	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	53	53	54	54	53
Units: Subjects
Any Pain	16	22	18	15	23
Any Redness	23	28	28	26	20
Any Swelling	15	19	18	18	12

No statistical analyses for this end point

Secondary: Number of subjects with solicited local symptoms in toddlers

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End point title

Number of subjects with solicited local symptoms in toddlers ^[5]

End point description

End point type

Secondary

End point timeframe

During the 8-day (Days 0-7) post-vaccination period after each dose and overall

Notes
[5] - 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: The endpoint analysis was based only on subjects of the control groups and all subjects in the group that received Nimenrix formulation 3.

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group
Number of subjects analysed	48	47	48	48	47
Units: Subjects
Any Pain, Men Vac (N=48,47,48,48,47)	11	5	8	7	8
Any Pain, DTPa (N=46,45,48,47,47)	11	10	13	13	10
Any Redness, Men Vac (N=48,47,48,48,47)	19	20	20	27	17
Any Redness, DTPa (N=46,45,48,47,47)	20	17	23	26	18
Any Swelling, Men Vac (N=48,47,48,48,47)	10	8	10	10	10
Any Swelling, DTPa (N=46,45,48,47,47)	14	8	16	16	11

No statistical analyses for this end point

Secondary: Number of subjects with solicited general symptoms in children

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End point title

Number of subjects with solicited general symptoms in children ^[6]

End point description

End point type

Secondary

End point timeframe

During the 8-day (Days 0-7) post-vaccination period

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: These symptoms were only reported in children.

End point values	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	53	53	54	54	53
Units: Subjects
Any Drowsiness	11	16	12	16	14
Any Fever	4	9	9	7	5
Any Irritability	11	10	10	16	12
Any Loss of appetite	5	16	6	12	7

No statistical analyses for this end point

Secondary: Number of subjects with solicited general symptoms in toddlers

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End point title

Number of subjects with solicited general symptoms in toddlers ^[7]

End point description

End point type

Secondary

End point timeframe

During the 8-day (Days 0-7) post-vaccination period following each study dose

Notes
[7] - 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: These symptoms were only reported in toddlers.

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group
Number of subjects analysed	48	47	48	48	47
Units: Subjects
Any Drowsiness, Men Vac (N=48,47,48,48,47)	19	16	17	20	18
Any Drowsiness, DTPa (N=46,45,48,47,47)	14	8	11	12	17
Any Fever, Men Vac (N=48,47,48,48,47)	9	15	12	12	16
Any Fever, DTPa (N=46,45,48,47,47)	15	16	16	14	20
Any Irritability, Men Vac (N=48,47,48,48,47)	22	16	16	21	19
Any Irritability, DTPa (N=46,45,48,47,47)	15	9	14	15	14
Any Loss of appetite, Men Vac (N=48,47,48,48,47)	9	10	11	9	11
Any Loss of appetite, DTPa (N=46,45,48,47,47)	9	7	8	12	9

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited Adverse events (AEs)

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End point title

Number of subjects with unsolicited Adverse events (AEs)

End point description

End point type

Secondary

End point timeframe

Within 31 days (Days 0-30) after the primary vaccination

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	48	48	48	48	48	54	53	54	54	53
Units: Subjects
Any AEs	30	29	30	27	29	21	22	21	22	15

No statistical analyses for this end point

Secondary: Number (%) of subjects with Serious Adverse Events (SAEs)

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End point title

Number (%) of subjects with Serious Adverse Events (SAEs)

End point description

End point type

Secondary

End point timeframe

During the primary vaccination study

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	48	48	48	48	48	54	53	54	54	53
Units: Subjects
Any SAEs	1	1	1	3	1	1	1	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8 ^[8]

End point description

End point type

Secondary

End point timeframe

15 months after priming

Notes
[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: The endpoint analysis was based only on subjects of the control groups and all subjects in the group that received Nimenrix formulation 3.

End point values	12-14 months of age Formulation 3 Group	12-14 months of age Control Group	3-5 years of age Formulation 3 Group	3-5 years of age Control Group
Number of subjects analysed	40	41	46	34
Units: Subjects
rSBA-MenA L10 (N=40,36,45,29)	39	11	45	26
rSBA-MenA L11 (N=39,31,46,33)	38	25	46	32
rSBA-MenC (N=39,40,46,32)	36	24	46	19
rSBA-MenW-135 3193 (N=40,40,46,34)	39	17	46	32
rSBA-MenW-135 MP (N=40,41,46,32)	39	17	46	30
rSBA-MenY (N= 40,40,46,33)	39	30	46	26

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128. ^[9]

End point description

End point type

Secondary

End point timeframe

15 months after priming

Notes
[9] - 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: The endpoint analysis was based only on subjects of the control groups and all subjects in the group that received Nimenrix formulation 3.

End point values	12-14 months of age Formulation 3 Group	12-14 months of age Control Group	3-5 years of age Formulation 3 Group	3-5 years of age Control Group
Number of subjects analysed	40	41	46	34
Units: Subjects
rSBA-MenA L10 (N=40,36,45,29)	37	10	44	24
rSBA-MenA L11 (N=39,31,46,33)	36	23	46	32
rSBA-MenC (N=39,40,46,32)	27	11	30	9
rSBA-MenW-135 3193 (N=40,40,46,34)	38	10	46	30
rSBA-MenW-135 MP (N=40,41,46,32)	36	11	46	30
rSBA-MenY (N= 40,40,46,33)	36	18	46	22

No statistical analyses for this end point

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

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End point title

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ^[10]

End point description

End point type

Secondary

End point timeframe

15 months after priming

Notes
[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: The endpoint analysis was based only on subjects of the control groups and all subjects in the group that received Nimenrix formulation 3.

End point values	12-14 months of age Formulation 3 Group	12-14 months of age Control Group	3-5 years of age Formulation 3 Group	3-5 years of age Control Group
Number of subjects analysed	40	41	46	34
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA L10 (N=40,36,45,29)	573.7 (373.3 to 881.7)	14.3 (7.3 to 27.8)	891.1 (693.1 to 1145.8)	251.3 (137.4 to 459.8)
rSBA-MenA L11 (N=39,31,46,33)	1385.1 (820.5 to 2338.3)	184.6 (85.5 to 398.7)	2619.6 (2125.2 to 3229.1)	879.5 (579 to 1336)
rSBA-MenC (N=39,40,46,32)	172 (108.7 to 272.1)	28 (15 to 52.6)	187.6 (124.3 to 283.2)	28.6 (14.3 to 57.1)
rSBA-MenW-135 3193 (N=40,40,46,34)	528.2 (368.6 to 756.7)	18.6 (10.2 to 33.9)	961.6 (731.2 to 1264.6)	239.3 (157.1 to 364.7)
rSBA-MenW-135 MP (N=40,41,46,32)	692 (462.4 to 1035.6)	18.7 (10.1 to 34.7)	1564.1 (1174.6 to 2082.7)	365.9 (228.4 to 586.2)
rSBA-MenY (N= 40,40,46,33)	477.2 (321.3 to 708.6)	76.9 (41.2 to 143.5)	1287.4 (1001.8 to 1654.3)	139.4 (66.9 to 290.7)

No statistical analyses for this end point

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

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End point title

Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations ^[11]

End point description

End point type

Secondary

End point timeframe

15 months after priming

Notes
[11] - 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: The endpoint analysis was based only on subjects of the control groups and all subjects in the group that received Nimenrix formulation 3.

End point values	12-14 months of age Formulation 3 Group	12-14 months of age Control Group	3-5 years of age Formulation 3 Group	3-5 years of age Control Group
Number of subjects analysed	36	37	32	32
Units: μg/mL
geometric mean (confidence interval 95%)
Anti-PSA (N=34,32,40,32)	0.65 (0.44 to 0.95)	0.16 (0.14 to 0.17)	1.04 (0.67 to 1.62)	2.71 (1.54 to 4.78)
Anti-PSC (N=36,37,46,31)	0.35 (0.25 to 0.49)	0.27 (0.2 to 0.36)	0.4 (0.27 to 0.6)	2.72 (1.68 to 4.42)
Anti-PSW-135 (N=34,34,41,31)	1.09 (0.78 to 1.53)	0.15 (0.15 to 0.15)	0.43 (0.34 to 0.54)	2.33 (1.29 to 4.2)
Anti-PSY (N=35,34,40,28)	1.5 (1.06 to 2.11)	0.15 (0.15 to 0.15)	0.71 (0.51 to 0.98)	4.46 (2.47 to 8.07)

No statistical analyses for this end point

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

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End point title

Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL ^[12]

End point description

End point type

Secondary

End point timeframe

15 months after priming

Notes
[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: The endpoint analysis was based only on subjects of the control groups and all subjects in the group that received Nimenrix formulation 3.

End point values	12-14 months of age Formulation 3 Group	12-14 months of age Control Group	3-5 years of age Formulation 3 Group	3-5 years of age Control Group
Number of subjects analysed	36	37	41	32
Units: Subjects
Anti-PSA (N=34,32,40,32)	25	1	33	29
Anti-PSC (N=36,37,46,31)	18	14	19	28
Anti-PSW-135 (N=34,34,41,31)	33	0	30	29
Anti-PSY (N=35,34,40,28)	33	0	33	26

No statistical analyses for this end point

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

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End point title

Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL ^[13]

End point description

End point type

Secondary

End point timeframe

15 months after priming

Notes
[13] - 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: The endpoint analysis was based only on subjects of the control groups and all subjects in the group that received Nimenrix formulation 3.

End point values	12-14 months of age Formulation 3 Group	12-14 months of age Control Group	3-5 years of age Formulation 3 Group	3-5 years of age Control Group
Number of subjects analysed	36	37	41	32
Units: Subjects
Anti-PSA (N=34,32,40,32)	6	0	13	21
Anti-PSC (N=36,37,46,31)	3	1	6	21
Anti-PSW-135 (N=34,34,41,31)	7	0	1	16
Anti-PSY (N=35,34,40,28)	14	0	6	21

No statistical analyses for this end point

Secondary: Number of subjects with solicited local symptoms

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End point title

Number of subjects with solicited local symptoms

End point description

End point type

Secondary

End point timeframe

During the 8-day follow-up period (Day 0-7) following the vaccine administration

End point values	12-14 months of age Challenge Group	12-14 months of age Control Group
Number of subjects analysed	42	42
Units: Subjects
Any Pain	7	8
Any Redness	13	12
Any Swelling	4	4

No statistical analyses for this end point

Secondary: Number of subjects with solicited general symptoms

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End point title

Number of subjects with solicited general symptoms

End point description

End point type

Secondary

End point timeframe

During the 8-day follow-up period (Day 0-7) following the vaccine administration

End point values	12-14 months of age Challenge Group	12-14 months of age Control Group
Number of subjects analysed	42	42
Units: Subjects
Any Drowsiness	9	9
Any Fever	9	5
Any Irritability	7	5
Any Loss of appetite	6	10

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited Adverse events (AEs)

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End point title

Number of subjects with unsolicited Adverse events (AEs)

End point description

End point type

Secondary

End point timeframe

Within the 31-day follow-up period (Day 0-30) following the vaccine administration

End point values	12-14 months of age Challenge Group	12-14 months of age Control Group
Number of subjects analysed	42	43
Units: Subjects
Any AEs	14	12

No statistical analyses for this end point

Secondary: Number (%) of subjects with Serious Adverse Events (SAEs)

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End point title

Number (%) of subjects with Serious Adverse Events (SAEs)

End point description

End point type

Secondary

End point timeframe

Between completion of the primary phase and the start of the persistence/challenge phase

End point values	12-14 months of age Challenge Group	12-14 months of age Control Group	3-5 years of age Challenge Group	3-5 years of age Control Group
Number of subjects analysed	42	43	50	50
Units: Subjects
Any SAEs	0	1	1	2

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

End point description

End point type

Secondary

End point timeframe

1 month after the administration of the challenge dose

End point values	12-14 months of age Challenge Group	12-14 months of age Control Group
Number of subjects analysed	32	30
Units: Subjects
rSBA-MenA L10 (N=25,30)	25	30
rSBA-MenA L11 (N=18,29)	18	29
rSBA-MenC (N=32,30)	32	30
rSBA-MenW-135 3193 (N=32,30)	32	30
rSBA-MenW-135 MP (N=32,30)	32	30
rSBA-MenY (N=32,30)	32	29

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

End point description

End point type

Secondary

End point timeframe

1 month after the administration of the challenge dose

End point values	12-14 months of age Challenge Group	12-14 months of age Control Group
Number of subjects analysed	32	30
Units: Subjects
rSBA-MenA L10 (N=25,30)	25	27
rSBA-MenA L11 (N=18,29)	18	28
rSBA-MenC (N=32,30)	32	30
rSBA-MenW-135 3193 (N=32,30)	32	29
rSBA-MenW-135 MP (N=32,30)	32	29
rSBA-MenY (N=32,30)	32	28

No statistical analyses for this end point

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

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End point title

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

End point description

End point type

Secondary

End point timeframe

1 month after the administration of the challenge dose

End point values	12-14 months of age Challenge Group	12-14 months of age Control Group
Number of subjects analysed	32	30
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA L10 (N=25,30)	3321.9 (2294.2 to 4810)	514.1 (354.8 to 744.8)
rSBA-MenA L11 (N=18,29)	4271.8 (3092.6 to 5900.8)	1349.4 (942.5 to 1932)
rSBA-MenC (N=32.30)	5965.7 (4128.4 to 8620.7)	5265.2 (3437.3 to 8065.1)
rSBA-MenW-135 3193 (N=32,30)	8677.4 (6501.9 to 11580.8)	1044.6 (694.7 to 1570.6)
rSBA-MenW-135 MP (N=32,30)	11058.1 (8587.2 to 14239.9)	1386.1 (935.6 to 2053.6)
rSBA-MenY (N=32,30)	5736.6 (4215.9 to 7806)	546.5 (324 to 921.8)

No statistical analyses for this end point

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

Top of page

End point title

Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

End point description

End point type

Secondary

End point timeframe

1 month after the administration of the challenge dose

End point values	12-14 months of age Challenge Group	12-14 months of age Control Group
Number of subjects analysed	31	31
Units: Subjects
Anti-PSA (N=29,26)	29	25
Anti-PSC (N=31,30)	31	30
Anti-PSW-135 (N=30,28)	30	26
Anti-PSY (N=29,30)	29	29

No statistical analyses for this end point

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

Top of page

End point title

Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

End point description

End point type

Secondary

End point timeframe

1 month after the administration of the challenge dose

End point values	12-14 months of age Challenge Group	12-14 months of age Control Group
Number of subjects analysed	31	30
Units: Subjects
Anti-PSA (N=29,26)	29	15
Anti-PSC (N=31,30)	27	30
Anti-PSW-135 (N=30,28)	30	16
Anti-PSY (N=29,30)	29	23

No statistical analyses for this end point

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

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End point title

Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

End point description

End point type

Secondary

End point timeframe

1 month after the administration of the challenge dose

End point values	12-14 months of age Challenge Group	12-14 months of age Control Group
Number of subjects analysed	31	30
Units: μg/mL
geometric mean (confidence interval 95%)
Anti-PSA (N=29,26)	42.51 (29.65 to 60.94)	2.47 (1.38 to 4.41)
Anti-PSC (N=31,30)	6.82 (4.9 to 9.48)	18.33 (14.36 to 23.4)
Anti-PSW-135 (N=30,28)	122.17 (85.74 to 174.07)	2.08 (1.22 to 3.56)
Anti-PSY (N=29,30)	130.17 (91.23 to 185.72)	4.64 (2.73 to 7.89)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

10.0

Reporting group title

12-14 months of age Formulation 1 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 2 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 3 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 4 Group

Reporting group description

Reporting group title

12-14 months of age Control Group

Reporting group description

Reporting group title

3-5 years of age Formulation 1 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 2 Group

Reporting group description

Reporting group title

3-5 years of age Control Group

Reporting group description

Reporting group title

3-5 years of age Formulation 4 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 3 Group

Reporting group description

Reporting group title

12-14 months of age Control Group

Reporting group description

Reporting group title

12-14 months of age Challenge Group

Reporting group description

Reporting group title

3-5 years of age Challenge Group

Reporting group description

Reporting group title

3-5 years of age Control Group

Reporting group description

12-14 months of age Formulation 1 Group

12-14 months of age Formulation 2 Group

12-14 months of age Formulation 3 Group

12-14 months of age Formulation 4 Group

12-14 months of age Control Group

3-5 years of age Formulation 1 Group

3-5 years of age Formulation 2 Group

3-5 years of age Control Group

3-5 years of age Formulation 4 Group

3-5 years of age Formulation 3 Group

12-14 months of age Control Group

12-14 months of age Challenge Group

3-5 years of age Challenge Group

3-5 years of age Control Group

Total subjects affected by serious adverse events

subjects affected / exposed

1 / 48 (2.08%)

3 / 48 (6.25%)

1 / 48 (2.08%)

1 / 54 (1.85%)

1 / 53 (1.89%)

0 / 53 (0.00%)

0 / 54 (0.00%)

1 / 43 (2.33%)

0 / 42 (0.00%)

1 / 50 (2.00%)

2 / 50 (4.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Nervous system disorders

Facial paresis

subjects affected / exposed

0 / 48 (0.00%)

0 / 54 (0.00%)

0 / 53 (0.00%)

0 / 54 (0.00%)

0 / 43 (0.00%)

0 / 42 (0.00%)

0 / 50 (0.00%)

1 / 50 (2.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Eye disorders

Conjunctivitis

subjects affected / exposed

0 / 48 (0.00%)

0 / 54 (0.00%)

0 / 53 (0.00%)

0 / 54 (0.00%)

1 / 43 (2.33%)

0 / 42 (0.00%)

0 / 50 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Vomiting

subjects affected / exposed

0 / 48 (0.00%)

1 / 48 (2.08%)

0 / 48 (0.00%)

0 / 54 (0.00%)

0 / 53 (0.00%)

0 / 54 (0.00%)

0 / 43 (0.00%)

0 / 42 (0.00%)

0 / 50 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Gastroenteritis

subjects affected / exposed

0 / 48 (0.00%)

1 / 48 (2.08%)

0 / 48 (0.00%)

0 / 54 (0.00%)

0 / 53 (0.00%)

0 / 54 (0.00%)

0 / 43 (0.00%)

0 / 42 (0.00%)

0 / 50 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastroenteritis rotavirus

subjects affected / exposed

0 / 48 (0.00%)

1 / 48 (2.08%)

1 / 54 (1.85%)

0 / 53 (0.00%)

0 / 54 (0.00%)

0 / 43 (0.00%)

0 / 42 (0.00%)

0 / 50 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal infection

subjects affected / exposed

1 / 48 (2.08%)

0 / 48 (0.00%)

0 / 54 (0.00%)

0 / 53 (0.00%)

0 / 54 (0.00%)

0 / 43 (0.00%)

0 / 42 (0.00%)

0 / 50 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mastoiditis

subjects affected / exposed

0 / 48 (0.00%)

1 / 48 (2.08%)

0 / 48 (0.00%)

0 / 54 (0.00%)

0 / 53 (0.00%)

0 / 54 (0.00%)

0 / 43 (0.00%)

0 / 42 (0.00%)

1 / 50 (2.00%)

0 / 50 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 48 (0.00%)

1 / 48 (2.08%)

0 / 48 (0.00%)

0 / 54 (0.00%)

0 / 53 (0.00%)

0 / 54 (0.00%)

0 / 43 (0.00%)

0 / 42 (0.00%)

0 / 50 (0.00%)

1 / 50 (2.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Upper respiratory tract infection

subjects affected / exposed

0 / 48 (0.00%)

1 / 48 (2.08%)

0 / 48 (0.00%)

0 / 54 (0.00%)

0 / 53 (0.00%)

0 / 54 (0.00%)

0 / 43 (0.00%)

0 / 42 (0.00%)

0 / 50 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Otitis media

subjects affected / exposed

0 / 48 (0.00%)

0 / 54 (0.00%)

1 / 53 (1.89%)

0 / 53 (0.00%)

0 / 54 (0.00%)

1 / 43 (2.33%)

0 / 42 (0.00%)

0 / 50 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pseudocroup

subjects affected / exposed

0 / 48 (0.00%)

0 / 54 (0.00%)

0 / 53 (0.00%)

0 / 54 (0.00%)

1 / 43 (2.33%)

0 / 42 (0.00%)

0 / 50 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Control Group	3-5 years of age Formulation 4 Group	3-5 years of age Formulation 3 Group	12-14 months of age Control Group	12-14 months of age Challenge Group	3-5 years of age Challenge Group	3-5 years of age Control Group
Total subjects affected by non serious adverse events
subjects affected / exposed	30 / 48 (62.50%)	29 / 48 (60.42%)	30 / 48 (62.50%)	27 / 48 (56.25%)	29 / 48 (60.42%)	23 / 54 (42.59%)	28 / 53 (52.83%)	23 / 53 (43.40%)	26 / 54 (48.15%)	28 / 54 (51.85%)	12 / 43 (27.91%)	14 / 42 (33.33%)	0 / 50 (0.00%)	0 / 50 (0.00%)
Nervous system disorders
Headache
subjects affected / exposed	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 53 (0.00%)	3 / 53 (5.66%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	0	0	0	0	0	0	3	0	0	0	0	0	0
General disorders and administration site conditions
Pain
alternative assessment type: Systematic
subjects affected / exposed ^[1]	11 / 48 (22.92%)	5 / 47 (10.64%)	8 / 46 (17.39%)	7 / 48 (14.58%)	8 / 47 (17.02%)	16 / 53 (30.19%)	22 / 53 (41.51%)	23 / 53 (43.40%)	15 / 54 (27.78%)	18 / 54 (33.33%)	8 / 42 (19.05%)	7 / 42 (16.67%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	11	5	8	7	8	16	22	23	15	18	8	7	0	0
Redness
alternative assessment type: Systematic
subjects affected / exposed ^[2]	19 / 48 (39.58%)	20 / 47 (42.55%)	20 / 48 (41.67%)	27 / 48 (56.25%)	17 / 47 (36.17%)	23 / 53 (43.40%)	28 / 53 (52.83%)	20 / 53 (37.74%)	26 / 54 (48.15%)	28 / 54 (51.85%)	12 / 42 (28.57%)	13 / 42 (30.95%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	19	20	20	27	17	23	28	20	26	28	12	13	0	0
Swelling
alternative assessment type: Systematic
subjects affected / exposed ^[3]	10 / 48 (20.83%)	8 / 47 (17.02%)	10 / 48 (20.83%)	10 / 48 (20.83%)	10 / 47 (21.28%)	15 / 53 (28.30%)	19 / 53 (35.85%)	12 / 53 (22.64%)	18 / 54 (33.33%)	18 / 54 (33.33%)	4 / 42 (9.52%)	4 / 42 (9.52%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	10	8	10	10	10	15	19	12	18	18	4	4	0	0
Drowsiness
alternative assessment type: Systematic
subjects affected / exposed ^[4]	19 / 48 (39.58%)	16 / 47 (34.04%)	17 / 48 (35.42%)	20 / 48 (41.67%)	18 / 47 (38.30%)	11 / 53 (20.75%)	16 / 53 (30.19%)	14 / 53 (26.42%)	16 / 54 (29.63%)	12 / 54 (22.22%)	9 / 42 (21.43%)	9 / 42 (21.43%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	19	16	17	20	18	11	16	14	16	12	9	9	0	0
Fever
alternative assessment type: Systematic
subjects affected / exposed ^[5]	9 / 48 (18.75%)	15 / 47 (31.91%)	12 / 48 (25.00%)	12 / 48 (25.00%)	16 / 47 (34.04%)	4 / 53 (7.55%)	9 / 53 (16.98%)	5 / 53 (9.43%)	7 / 54 (12.96%)	9 / 54 (16.67%)	5 / 42 (11.90%)	9 / 42 (21.43%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	9	15	12	12	16	4	9	5	7	9	5	9	0	0
Irritability
alternative assessment type: Systematic
subjects affected / exposed ^[6]	22 / 48 (45.83%)	16 / 47 (34.04%)	16 / 48 (33.33%)	21 / 48 (43.75%)	19 / 47 (40.43%)	11 / 53 (20.75%)	10 / 53 (18.87%)	12 / 53 (22.64%)	16 / 54 (29.63%)	10 / 54 (18.52%)	5 / 42 (11.90%)	7 / 42 (16.67%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	22	16	16	21	19	11	10	12	16	10	5	7	0	0
Loss of appetite
alternative assessment type: Systematic
subjects affected / exposed ^[7]	9 / 48 (18.75%)	10 / 47 (21.28%)	11 / 48 (22.92%)	9 / 48 (18.75%)	11 / 47 (23.40%)	5 / 53 (9.43%)	16 / 53 (30.19%)	7 / 53 (13.21%)	12 / 54 (22.22%)	6 / 54 (11.11%)	10 / 42 (23.81%)	6 / 42 (14.29%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	9	10	11	9	11	5	16	7	12	6	10	6	0	0
Pyrexia
subjects affected / exposed	3 / 48 (6.25%)	4 / 48 (8.33%)	4 / 48 (8.33%)	0 / 48 (0.00%)	3 / 48 (6.25%)	1 / 54 (1.85%)	3 / 53 (5.66%)	0 / 53 (0.00%)	4 / 54 (7.41%)	1 / 54 (1.85%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	3	4	4	0	3	1	3	0	4	1	0	0	0	0
Pain - Booster Phase
alternative assessment type: Systematic
subjects affected / exposed ^[8]	11 / 48 (22.92%)	10 / 45 (22.22%)	13 / 48 (27.08%)	13 / 47 (27.66%)	10 / 47 (21.28%)	0 / 54 (0.00%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	11	10	13	13	10	0	0	0	0	0	0	0	0	0
Redness - Booster Phase
alternative assessment type: Systematic
subjects affected / exposed ^[9]	20 / 48 (41.67%)	17 / 45 (37.78%)	23 / 48 (47.92%)	26 / 47 (55.32%)	18 / 47 (38.30%)	0 / 54 (0.00%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	20	17	23	26	18	0	0	0	0	0	0	0	0	0
Swelling - Booster Phase
alternative assessment type: Systematic
subjects affected / exposed ^[10]	14 / 46 (30.43%)	8 / 45 (17.78%)	16 / 48 (33.33%)	16 / 48 (33.33%)	11 / 47 (23.40%)	0 / 54 (0.00%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	14	8	16	16	11	0	0	0	0	0	0	0	0	0
Drowsiness - Booster Phase
alternative assessment type: Systematic
subjects affected / exposed ^[11]	14 / 46 (30.43%)	8 / 45 (17.78%)	11 / 48 (22.92%)	12 / 47 (25.53%)	17 / 47 (36.17%)	0 / 54 (0.00%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	14	8	11	12	17	0	0	0	0	0	0	0	0	0
Fever - Booster Phase
alternative assessment type: Systematic
subjects affected / exposed ^[12]	15 / 46 (32.61%)	16 / 45 (35.56%)	16 / 48 (33.33%)	14 / 47 (29.79%)	20 / 47 (42.55%)	0 / 54 (0.00%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	15	16	16	14	20	0	0	0	0	0	0	0	0	0
Irritability - Booster Phase
alternative assessment type: Systematic
subjects affected / exposed ^[13]	15 / 46 (32.61%)	9 / 45 (20.00%)	14 / 48 (29.17%)	15 / 47 (31.91%)	14 / 47 (29.79%)	0 / 54 (0.00%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	15	9	14	15	14	0	0	0	0	0	0	0	0	0
Loss of appetite - Booster Phase
alternative assessment type: Systematic
subjects affected / exposed ^[14]	9 / 46 (19.57%)	7 / 45 (15.56%)	8 / 48 (16.67%)	12 / 47 (25.53%)	9 / 47 (19.15%)	0 / 54 (0.00%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	9	7	8	12	9	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
Vomiting
subjects affected / exposed	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 48 (0.00%)	2 / 48 (4.17%)	3 / 48 (6.25%)	1 / 54 (1.85%)	3 / 53 (5.66%)	1 / 53 (1.89%)	0 / 54 (0.00%)	1 / 54 (1.85%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	0	0	2	3	1	3	1	0	1	0	0	0	0
Enteritis
subjects affected / exposed	5 / 48 (10.42%)	3 / 48 (6.25%)	0 / 48 (0.00%)	6 / 48 (12.50%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 54 (0.00%)	1 / 43 (2.33%)	1 / 42 (2.38%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	5	3	0	6	0	0	0	0	0	0	1	1	0	0
Diarrhea
subjects affected / exposed	2 / 48 (4.17%)	0 / 48 (0.00%)	3 / 48 (6.25%)	2 / 48 (4.17%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 53 (0.00%)	2 / 53 (3.77%)	0 / 54 (0.00%)	1 / 54 (1.85%)	1 / 43 (2.33%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	2	0	3	2	0	1	0	2	0	1	1	0	0	0
Toothache
subjects affected / exposed	0 / 48 (0.00%)	3 / 48 (6.25%)	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 48 (0.00%)	2 / 48 (4.17%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 53 (0.00%)	1 / 53 (1.89%)	3 / 54 (5.56%)	4 / 54 (7.41%)	2 / 43 (4.65%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	0	0	2	0	0	0	1	3	4	2	0	0	0
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	7 / 48 (14.58%)	8 / 48 (16.67%)	10 / 48 (20.83%)	8 / 48 (16.67%)	10 / 48 (20.83%)	3 / 54 (5.56%)	2 / 53 (3.77%)	1 / 53 (1.89%)	0 / 54 (0.00%)	5 / 54 (9.26%)	2 / 43 (4.65%)	4 / 42 (9.52%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	7	8	10	8	10	3	2	1	0	5	2	4	0	0
Nasopharyngitis
subjects affected / exposed	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 53 (0.00%)	4 / 53 (7.55%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	0	0	0	0	1	0	4	0	0	0	0	0	0
Otitis media
subjects affected / exposed	2 / 48 (4.17%)	6 / 48 (12.50%)	3 / 48 (6.25%)	4 / 48 (8.33%)	5 / 48 (10.42%)	1 / 54 (1.85%)	2 / 53 (3.77%)	1 / 53 (1.89%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	2	6	3	4	5	1	2	1	0	0	0	0	0	0
Bronchitis
subjects affected / exposed	2 / 48 (4.17%)	0 / 48 (0.00%)	5 / 48 (10.42%)	2 / 48 (4.17%)	4 / 48 (8.33%)	1 / 54 (1.85%)	0 / 53 (0.00%)	0 / 53 (0.00%)	2 / 54 (3.70%)	1 / 54 (1.85%)	0 / 43 (0.00%)	1 / 42 (2.38%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	2	0	5	2	4	1	0	0	2	1	0	1	0	0
Rhinitis
subjects affected / exposed	2 / 48 (4.17%)	3 / 48 (6.25%)	0 / 48 (0.00%)	2 / 48 (4.17%)	3 / 48 (6.25%)	2 / 54 (3.70%)	0 / 53 (0.00%)	2 / 53 (3.77%)	2 / 54 (3.70%)	2 / 54 (3.70%)	1 / 43 (2.33%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	2	3	0	2	3	2	0	2	2	2	1	0	0	0
Pharyngitis
subjects affected / exposed	2 / 48 (4.17%)	4 / 48 (8.33%)	0 / 48 (0.00%)	0 / 48 (0.00%)	3 / 48 (6.25%)	2 / 54 (3.70%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 54 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	2	4	0	0	3	2	0	0	0	0	0	0	0	0
Tonsillitis
subjects affected / exposed	0 / 48 (0.00%)	3 / 48 (6.25%)	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	1 / 54 (1.85%)	1 / 43 (2.33%)	0 / 42 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	3	0	0	0	1	0	0	0	1	1	0	0	0

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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[8] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[9] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[10] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[11] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[12] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[13] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[14] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

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Were there any global substantial amendments to the protocol? Yes

11 Jul 2006

The study was planned to be done in two stages, with Stage 2 being done 12 months after vaccination in Stage 1; Stage 2 includes children part of the control groups and only those children part of the group with the selected MenACWY-TT formulation (selection being done based on Stage 1 data). Due to slow enrolment of the subjects in Stage 1 of the study, the interim analysis of the data pertaining to Stage 1 has been delayed. In order to allow for completion of the interim analysis, selection of the best dose and labelling and shipping of the vaccines, this amendment proposes that the start of Study Stage 2 be delayed by 3 months (i.e., children participating to Stage 2 will enter Stage 2 15 months after vaccination in Stage 1 instead of 12 months as initially planned). To further characterise the immune response induced by the vaccine, bactericidal assays using human complement source will be performed on a subset of subjects (i.e., those who received the selected formulation and the control groups). The protocol initially planned to use bactericidal assays using baby rabbit complement only. It was not clear in the original protocol which data (available up to 1 month or 2 months after primary vaccination) would be used to select the best MenACWY formulation. The protocol was amended to make clear that the data available up to 1 month after primary vaccination would be used.

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: Number of subjects with an immune response to the serum bactericidal assay meningococcal serogroup A using rabbit complement (rSBA-MenA), rSBA-MenC, rSBA-MenW-135, rSBA-MenY

Primary: Number of subjects with an immune response to the serum bactericidal assay meningococcal serogroup A using rabbit complement (rSBA-MenA), rSBA-MenC, rSBA-MenW-135, rSBA-MenY

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

Secondary: Number of subjects with anti-tetanus (anti-T) antibody titers ≥ 0.1 IU/mL

Secondary: Number of subjects with anti-tetanus (anti-T) antibody titers ≥ 0.1 IU/mL

Secondary: Anti-tetanus (anti-T) antibody concentrations

Secondary: Anti-tetanus (anti-T) antibody concentrations

Secondary: Number of subjects with serum bactericidal assay using human complement (hSBA-MenA, hSBA-MenC ,hSBA-MenW-135, hSBA-MenY) titers ≥ 1:4

Secondary: Number of subjects with serum bactericidal assay using human complement (hSBA-MenA, hSBA-MenC ,hSBA-MenW-135, hSBA-MenY) titers ≥ 1:4

Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers

Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers

Secondary: Number of subjects with solicited local symptoms in children

Secondary: Number of subjects with solicited local symptoms in children

Secondary: Number of subjects with solicited local symptoms in toddlers

Secondary: Number of subjects with solicited local symptoms in toddlers

Secondary: Number of subjects with solicited general symptoms in children

Secondary: Number of subjects with solicited general symptoms in children

Secondary: Number of subjects with solicited general symptoms in toddlers

Secondary: Number of subjects with solicited general symptoms in toddlers

Secondary: Number of subjects with unsolicited Adverse events (AEs)

Secondary: Number of subjects with unsolicited Adverse events (AEs)

Secondary: Number (%) of subjects with Serious Adverse Events (SAEs)

Secondary: Number (%) of subjects with Serious Adverse Events (SAEs)

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

Secondary: Number of subjects with solicited local symptoms

Secondary: Number of subjects with solicited local symptoms

Secondary: Number of subjects with solicited general symptoms

Secondary: Number of subjects with solicited general symptoms

Secondary: Number of subjects with unsolicited Adverse events (AEs)

Secondary: Number of subjects with unsolicited Adverse events (AEs)

Secondary: Number (%) of subjects with Serious Adverse Events (SAEs)

Secondary: Number (%) of subjects with Serious Adverse Events (SAEs)

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:128.

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 0.3 μg/mL

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

Secondary: Number of subjects with Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti- PSY antibody concentrations ≥ 2.0 μg/mL

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti- PSW-135 and anti-PSY antibody concentrations

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)