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Clinical Trial Results:
Phase IV, open-label, randomized study to enrol healthy adult volunteers, naïve to any previous meningococcal vaccination or meningococcal disease, aged 18-50 years, to be either vaccinated with GSK MenACWY vaccine (Menveo) or GSK rMenB+OMV NZ vaccine (Bexsero), and serve as donors of human blood for conversion into serum to use in the development, qualification, validation and maintenance of immunological assays and to support preclinical research activities, clinical development and life cycle management of GSK Biologicals vaccines

Summary
EudraCT number	2017-002919-33
Trial protocol	DE
Global end of trial date	22 Jun 2022

Results information
Results version number	v1(current)
This version publication date	11 Jun 2023
First version publication date	11 Jun 2023
Other versions

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

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Trial information

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Sponsor protocol code

207911

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

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

Public contact

GSK Response Center, GlaxoSmithKline, 044 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 044 8664357343, 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?

Analysis stage

Final

Date of interim/final analysis

28 Sep 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

27 May 2022

Global end of trial reached?

Yes

Global end of trial date

22 Jun 2022

Was the trial ended prematurely?

Main objective of the trial

To collect baseline (Visit 1, Visit 2 or Visit 3, depending on the study group) and post vaccination (Visits 5, 8; Visits 5, 9; Visits 6, 9 or Visits 7, 9, depending on the study group) blood sample donations to serve for the development, qualification, validation and maintenance of immunological assays and to support the preclinical research activities, clinical development and life cycle management of GSK Biologicals’ vaccines.

Protection of trial subjects

Blood samples were obtained by trained professionals, and medical assistance was readily available. Blood was collected only from eligible subjects who did not present any reason for deferring the blood draw. All subjects were supervised for 30 minutes after vaccination, with appropriate medical treatment readily available. Vaccines were administered according to their marketing indication and SmPC (summary of product characteristics) only to eligible subjects who had no contraindications to any components of the vaccines/products.

Background therapy

Evidence for comparator

Actual start date of recruitment

08 Mar 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 463

Country: Number of subjects enrolled

Germany: 558

Worldwide total number of subjects

1021

EEA total number of subjects

558

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

1021

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

To adhere to local health guidelines (Australian Red Cross, 2016), 3 MenACWY groups were formed to ensure minimum 90-day interval between blood drawn at Days -83, -60, -30, 31, 61, and 151. The rMenB+OMV NZ group was not split due to sufficient intervals between post-vaccination blood sampling points (Day 8 and Day 98).

Screening details

Out of 1021 participants enrolled, 60 participants did not receive vaccination as they did not meet the eligibility criteria or withdrew from the study, therefore only 961 participants were included in the Exposed Set and started the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

rMenB+OMV NZ Group

Arm description

Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.

Arm type

Experimental

Investigational medicinal product name

rMenB+OMV NZ

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Two doses of rMenB+OMV NZ vaccine at Day 1 and Day 61

MenACWY 1 Group

Arm description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.

Arm type

Experimental

Investigational medicinal product name

MenACWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Effervescent powder, Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of MenACWY vaccine at Day 1

MenACWY 2 Group

Arm description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151.

Arm type

Experimental

Investigational medicinal product name

MenACWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Effervescent powder, Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of MenACWY vaccine at Day 1

MenACWY 3 Group

Arm description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.

Arm type

Experimental

Investigational medicinal product name

MenACWY

Investigational medicinal product code

Other name

Pharmaceutical forms

Effervescent powder, Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose of MenACWY vaccine at Day 1

Number of subjects in period 1 ^[1]	rMenB+OMV NZ Group	MenACWY 1 Group	MenACWY 2 Group	MenACWY 3 Group
Started	470	165	165	161
Completed	454	161	163	157
Not completed	16	4	2	4
Consent withdrawn by subject	9	3	1	1
Adverse event, non-fatal	-	1	-	-
Other	2	-	1	-
Lost to follow-up	5	-	-	3

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Out of 1021 participants enrolled, 60 participants did not receive vaccination as they did not meet the eligibility criteria or withdrew from the study, therefore only 961 participants were included in the Exposed Set and started the study.

Baseline characteristics

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Reporting group title

rMenB+OMV NZ Group

Reporting group description

Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.

Reporting group title

MenACWY 1 Group

Reporting group description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.

Reporting group title

MenACWY 2 Group

Reporting group description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151.

Reporting group title

MenACWY 3 Group

Reporting group description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.

Reporting group values	rMenB+OMV NZ Group	MenACWY 1 Group	MenACWY 2 Group	MenACWY 3 Group	Total
Number of subjects	470	165	165	161	961
Age Categorical
Units: Participants
Age continuous
Units: years
arithmetic mean (standard deviation)	32.8 ± 8.8	33.3 ± 9.1	33.3 ± 9.0	32.9 ± 8.8	-
Sex: Female, Male
Units: Participants
Female	295	99	105	109	608
Male	175	66	60	52	353
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0
Asian	29	13	15	8	65
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	0	0	0
White	430	150	149	147	876
More than one race	9	2	1	6	18
Unknown or Not Reported	2	0	0	0	2

End points

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Reporting group title

rMenB+OMV NZ Group

Reporting group description

Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.

Reporting group title

MenACWY 1 Group

Reporting group description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.

Reporting group title

MenACWY 2 Group

Reporting group description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151.

Reporting group title

MenACWY 3 Group

Reporting group description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.

Primary: Number of human blood samples collected for conversion into serum at Day -83

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End point title

Number of human blood samples collected for conversion into serum at Day -83 ^[1] ^[2]

End point description

The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. At Day -83, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group. Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.

End point type

Primary

End point timeframe

At Day -83 [83 days before first vaccination (Day 1)]

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[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: On Day -83, blood samples were collected only for the rMenB+OMV NZ and MenACWY 1 groups. The participants included in this outcome measure are based on the data collected at specific blood sampling time points.

End point values	rMenB+OMV NZ Group	MenACWY 1 Group
Number of subjects analysed	470	165
Units: Blood samples
Number of Blood Samples Analyzed	5578	1936

No statistical analyses for this end point

Primary: Number of human blood samples collected for conversion into serum at Day 8

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End point title

Number of human blood samples collected for conversion into serum at Day 8 ^[3] ^[4]

End point description

The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. At Day 8, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group. Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.

End point type

Primary

End point timeframe

At Day 8

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[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: On Day 8, blood samples were collected only for the rMenB+OMV NZ and MenACWY 1 groups. The participants included in this outcome measure are based on the data collected at specific blood sampling time points.

End point values	rMenB+OMV NZ Group	MenACWY 1 Group
Number of subjects analysed	462	162
Units: Blood samples
Number of Blood Samples Analyzed	5396	1907

No statistical analyses for this end point

Primary: Number of human blood samples collected for conversion into serum at Day 98

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End point title

Number of human blood samples collected for conversion into serum at Day 98 ^[5] ^[6]

End point description

The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. At Day 98, blood samples were collected only for rMenB+OMV NZ group. Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.

End point type

Primary

End point timeframe

At Day 98

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[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: On Day 98, blood samples were collected only for the rMenB+OMV NZ group. The participants included in this outcome measure are based on the data collected at specific blood sampling time points.

End point values	rMenB+OMV NZ Group
Number of subjects analysed	454
Units: Blood samples
Number of Blood Samples Analyzed	5204

No statistical analyses for this end point

Primary: Number of human blood samples collected for conversion into serum at Day 151

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End point title

Number of human blood samples collected for conversion into serum at Day 151 ^[7] ^[8]

End point description

The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. At Day 151, blood samples were collected only for MenACWY 1, 2 and 3 group. Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.

End point type

Primary

End point timeframe

At Day 151

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[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: On Day 151, blood samples were collected only for MenACWY 1, 2, and 3 groups. The participants included in this outcome measure are based on the data collected at specific blood sampling time points.

End point values	MenACWY 1 Group	MenACWY 2 Group	MenACWY 3 Group
Number of subjects analysed	161	162	156
Units: Blood samples
Number of Blood Samples Analyzed	1869	1866	1752

No statistical analyses for this end point

Primary: Number of human blood samples collected for conversion into serum at Day -60

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End point title

Number of human blood samples collected for conversion into serum at Day -60 ^[9] ^[10]

End point description

The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. At Day -60, blood samples were collected only for MenACWY 2 group. Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.

End point type

Primary

End point timeframe

At Day -60 [60 days before first vaccination (Day 1)]

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[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: On Day -60, blood samples were collected only for the MenACWY 2 group. The participants included in this outcome measure are based on the data collected at specific blood sampling time points.

End point values	MenACWY 2 Group
Number of subjects analysed	165
Units: Blood samples
Number of Blood Samples Analyzed	1957

No statistical analyses for this end point

Primary: Number of human blood samples collected for conversion into serum at Day-30

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End point title

Number of human blood samples collected for conversion into serum at Day-30 ^[11] ^[12]

End point description

The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. At Day -30, blood samples were collected only for MenACWY 3 group. Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.

End point type

Primary

End point timeframe

At Day -30 [30 days before first vaccination (Day 1)]

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[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: On Day -30, blood samples were collected only for the MenACWY 3 group. The participants included in this outcome measure are based on the data collected at specific blood sampling time points.

End point values	MenACWY 3 Group
Number of subjects analysed	161
Units: Blood samples
Number of Blood Samples Analyzed	1894

No statistical analyses for this end point

Primary: Number of human blood samples collected for conversion into serum at Day 31

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End point title

Number of human blood samples collected for conversion into serum at Day 31 ^[13] ^[14]

End point description

The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. At Day 31, blood samples were collected only for MenACWY 2 group. Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.

End point type

Primary

End point timeframe

At Day 31

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: On Day 31, blood samples were collected only for the MenACWY 2 group. The participants included in this outcome measure are based on the data collected at specific blood sampling time points.

End point values	MenACWY 2 Group
Number of subjects analysed	163
Units: Blood samples
Number of Blood Samples Analyzed	1920

No statistical analyses for this end point

Primary: Number of human blood samples collected for conversion into serum at Day 61

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End point title

Number of human blood samples collected for conversion into serum at Day 61 ^[15] ^[16]

End point description

The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. At Day 61, blood samples were collected only for MenACWY 3 group. Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.

End point type

Primary

End point timeframe

At Day 61

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: On Day 61, blood samples were collected only for the MenACWY 3 group. The participants included in this outcome measure are based on the data collected at specific blood sampling time points.

End point values	MenACWY 3 Group
Number of subjects analysed	159
Units: Blood samples
Number of Blood Samples Analyzed	1809

No statistical analyses for this end point

Secondary: Number of participants with atleast one Serious Adverse Events (SAEs) related to vaccination

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End point title

Number of participants with atleast one Serious Adverse Events (SAEs) related to vaccination

End point description

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity in a subject or is a congenital anomaly/ birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician. Related=AE assessed by the investigator as related to the vaccination. Analysis was performed on blood samples collected from exposed set, which included all participants subjects in the exposed set who provide safety data.

End point type

Secondary

End point timeframe

Throughout the study period (approximately 4 years)

End point values	rMenB+OMV NZ Group	MenACWY 1 Group	MenACWY 2 Group	MenACWY 3 Group
Number of subjects analysed	470	165	165	161
Units: Participants	0	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Serious Adverse Events (SAEs) were collected throughout the study period (Upto 4 years)

Adverse event reporting additional description

According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

rMenB+OMV NZ Group

Reporting group description

Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61.

Reporting group title

MenACWY 3 Group

Reporting group description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1.

Reporting group title

MenACWY 2 Group

Reporting group description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1.

Reporting group title

MenACWY 1 Group

Reporting group description

Participants vaccinated intramuscularly with Menveo vaccine at Day 1.

Notes
[1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
Justification: According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.

Serious adverse events	rMenB+OMV NZ Group	MenACWY 3 Group	MenACWY 2 Group	MenACWY 1 Group
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 470 (0.64%)	0 / 161 (0.00%)	1 / 165 (0.61%)	1 / 165 (0.61%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events
Nervous system disorders
Depressed level of consciousness
subjects affected / exposed	0 / 470 (0.00%)	0 / 161 (0.00%)	1 / 165 (0.61%)	0 / 165 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Immune thrombocytopenia
subjects affected / exposed	0 / 470 (0.00%)	0 / 161 (0.00%)	0 / 165 (0.00%)	1 / 165 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Inguinal hernia
subjects affected / exposed	1 / 470 (0.21%)	0 / 161 (0.00%)	0 / 165 (0.00%)	0 / 165 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Adnexal torsion
subjects affected / exposed	1 / 470 (0.21%)	0 / 161 (0.00%)	0 / 165 (0.00%)	0 / 165 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 470 (0.21%)	0 / 161 (0.00%)	0 / 165 (0.00%)	0 / 165 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	rMenB+OMV NZ Group	MenACWY 3 Group	MenACWY 2 Group	MenACWY 1 Group
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 470 (0.00%)	0 / 161 (0.00%)	0 / 165 (0.00%)	0 / 165 (0.00%)

More information

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Were there any global substantial amendments to the protocol? Yes

18 Sep 2017

Detailed title, Primary Objective was reworded. Duration of the study for individual subjects was updated. Minor edits and wordings update have been made.

19 Jan 2018

Discrepancies have been noted in Study Design Overview and Intervals between study visits Table. Further, day number for Visits 5 to 9 needed to reflect in the following way: Visit 5: Day 8, Visit 6: Day 31, Visit 7: Day 61, Visit 8: 98 and Visit 9: 151.

13 Sep 2019

To clarify the minimum interval between first (blood draw) study visit and next (vaccination) study visit for all study groups

28 Apr 2020

The purpose of the amendment is to protect participant’s welfare, and as far as possible ensure the potential benefit to the participant and promote data integrity.

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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Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of human blood samples collected for conversion into serum at Day -83

Primary: Number of human blood samples collected for conversion into serum at Day -83

Primary: Number of human blood samples collected for conversion into serum at Day 8

Primary: Number of human blood samples collected for conversion into serum at Day 8

Primary: Number of human blood samples collected for conversion into serum at Day 98

Primary: Number of human blood samples collected for conversion into serum at Day 98

Primary: Number of human blood samples collected for conversion into serum at Day 151

Primary: Number of human blood samples collected for conversion into serum at Day 151

Primary: Number of human blood samples collected for conversion into serum at Day -60

Primary: Number of human blood samples collected for conversion into serum at Day -60

Primary: Number of human blood samples collected for conversion into serum at Day-30

Primary: Number of human blood samples collected for conversion into serum at Day-30

Primary: Number of human blood samples collected for conversion into serum at Day 31

Primary: Number of human blood samples collected for conversion into serum at Day 31

Primary: Number of human blood samples collected for conversion into serum at Day 61

Primary: Number of human blood samples collected for conversion into serum at Day 61

Secondary: Number of participants with atleast one Serious Adverse Events (SAEs) related to vaccination

Secondary: Number of participants with atleast one Serious Adverse Events (SAEs) related to vaccination

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
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