Clinical Trials Register

Summary
EudraCT Number:	2017-000093-11
Sponsor's Protocol Code Number:	205218
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2017-02-08
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2017-000093-11

A.3

Full title of the trial

A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Athe Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningococcal B Recombinant Vaccine and the Response to a Third Dose in Adolescents and Young Adult Subjects who Previously Participated in Parent Studies V72_41 (NCT01423084) and V72P10 (NCT00661713), Compared to Naïve Healthy Controls

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Combined Study – Phase 3b MenB Long Term Persistence in Adolescents.

A.3.2

Name or abbreviated title of the trial where available

MENB REC 2ND GEN-041 (V72_75)

A.4.1

Sponsor's protocol code number

205218

A.5.4

Other Identifiers

Name:

V72_75

Number:

Other identifier

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline Biologicals
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	GlaxoSmithKline Biologicals
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline Biologicals
B.5.2	Functional name of contact point	Clinical Disclosure Advisor
B.5.3	Address:
B.5.3.1	Street Address	Rue de l'Institut, 89
B.5.3.2	Town/ city	Rixensart
B.5.3.3	Post code	1330
B.5.3.4	Country	Belgium
B.5.4	Telephone number	44 2089904466
B.5.6	E-mail	GSKClinicalSupportHD@gsk.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Bexsero
D.2.1.1.2	Name of the Marketing Authorisation holder	GSK Vaccines S.r.l.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Bexsero - Meningococcal group B vaccine (rDNA, component, adsorbed)
D.3.2	Product code	rMenB+OMV NZ
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	_
D.3.9.2	Current sponsor code	NHBA
D.3.9.3	Other descriptive name	RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
D.3.9.4	EV Substance Code	SUB96088
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	_
D.3.9.2	Current sponsor code	NadA
D.3.9.3	Other descriptive name	RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
D.3.9.4	EV Substance Code	SUB96089
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	_
D.3.9.2	Current sponsor code	fHbp
D.3.9.3	Other descriptive name	RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
D.3.9.4	EV Substance Code	SUB96090
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	_
D.3.9.2	Current sponsor code	OMV
D.3.9.3	Other descriptive name	OUTER MEMBRANE VESICLES (OMV) FROM NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 MEASURED AS AMOUNT OF TOTAL PROTEIN CONTAINING THE PORA P1.4 ADSORBED ON ALUMINIUM HYDROXIDE
D.3.9.4	EV Substance Code	SUB96091
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Healthy volunteers (Infections, Meningococcal)

E.1.1.1

Medical condition in easily understood language

Meningitis

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

•To assess serum bactericidal activity at approximately 4 to 7.5 years following a 2 dose primary series (persistence) compared to serum bactericidal activity at baseline in vaccination-naïve subjects
•To assess and compare the safety and tolerability of a single dose (booster) of rMenB+OMV NZ administered to follow-on subjects approximately 4 to 7.5 years after a 2 dose primary series.

E.2.2

Secondary objectives of the trial

•To assess the immune response at 1 month after a third dose (booster) of rMenB+OMV NZ administered to follow-on subjects approximately 4 to 7.5 years after a 2 dose primary series, compared to the immune response at 1 month after the first dose of rMenB+OMV NZ administered to naïve subjects according to a 0, 1-month schedule
•To assess and compare the changes over time in the immune response (kinetics) at 3, 7 and 30 days after a third dose (booster) of rMenB+OMV NZ administered to follow-on subjects approximately 4 to 7.5 years after a 2 dose primary series, with that at 3, 7 and 30 days after the second dose of rMenB+OMV NZ administered to naïve subjects according to a 0,1-month schedule
•To assess the immune response at 1 month after the second dose (primary series) of rMenB+OMV NZ administered to naïve subjects according to a 0,1-month schedule.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criterion for follow-on subjects:
•Individuals who participated to Study V72_41 or V72P10 and have completed vaccination with rMenB+OMV NZ according to a 2-dose schedule
Inclusion Criterion for naïve subjects:
•Individuals of 15 through 21 years of age on the day of in-formed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72_41.
•17 through 24 years of age on the day of informed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72P10.
Inclusion Criteria for all subjects:
•Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
•Individuals who can comply with study procedures including follow-up.
•Males Or Females of non-childbearing potential Or Females of childbearing potential who are using an effective birth control method .

E.4

Principal exclusion criteria

Exclusion Criterion for follow-on subjects:
•Received a third dose of a Meningococcal group B vaccine prior to enrolment in this study.

Exclusion Criterion for naïve subjects:
•Received any other Meningococcal group B vaccines prior to enrolment in this study.

Exclusion Criteria for all subjects:
•Progressive, unstable or uncontrolled clinical conditions.
•Hypersensitivity, including allergy, to any component of vac-cines or medical equipment whose use is foreseen in this study.
•Abnormal function of the immune system.
•Received immunoglobulins or any blood products within 180 days prior to informed consent and assent as applicable (ac-cording to the subject’s age).
•Received an investigational or non-registered medicinal product within 30 days prior to informed consent and assent as applicable (according to the subject’s age).
•Study personnel as an immediate family or household mem-ber.
•Any other clinical condition that, in the opinion of the investi-gator, might pose additional risk to the subject due to partici-pation in the study.
•Positive results at the urine pregnancy test performed before study vaccination.

E.5 End points

E.5.1

Primary end point(s)

A) The frequencies and percentage of subjects with solicited local (i.e., injection site pain, erythema, swelling, induration) and systemic (i.e., fever [temperature ≥ 38.0°C], high fever [temperature ≥ 39.5°C], nausea, fatigue, myalgia, arthralgia, headache) AEs.
B) The frequencies and percentages of subjects with any unsolicited adverse events (AEs).
C) The frequencies and percentage of subjects with any serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs.
D) Percentage of subjects with hSBA ≥1:5, hSBA ≥1:8, hSBA ≥1:16 in follow on and naive subjects.
E) hSBA GMT in follow on and naive subjects.
F) Geometric mean ratios (GMRs) of GMTs pre-vaccination versus 1 month after last vaccine dose in parent studies.

E.5.1.1

Timepoint(s) of evaluation of this end point

A) 7 days (including the day of vaccination) after each vaccination.
B) 30 days (including the day of vaccination) after each vaccination.
C) average of 1 Months (up to 30 days ) after last dose (booster for follow on subjects and second dose for naive subjects).
D) baseline (pre-booster in follow on subjects and and pre first dose in naive subjects)
E) baseline (pre-booster in follow on subjects and and pre first dose in naive subjects)
F) pre-vaccination versus 1 month after last vaccine dose in parent studies

E.5.2

Secondary end point(s)

A) Percentage of subjects with hSBA ≥1:5, hSBA ≥1:8, hSBA ≥1:16 and hSBA GMTs in follow on and naive subjects.
B) GMRs of GMTs of one month post-vaccination of a booster dose versus pre-booster dose (follow-on subjects) or first dose versus pre-first dose (naïve subjects).
C) Percentage of subjects with hSBA ≥1:5, hSBA ≥1:8, hSBA ≥1:16 and hSBA GMTs in follow on and naive subjects.
D) GMRs of GMTs post-vaccination with a booster dose (follow on subjects) versus pre-booster dose or second dose (naive subjects) versus pre-second dose.
E) Percentage of subjects with 4-fold rise pre-compared to three, seven, thirty days post-vaccination with a booster dose (follow-on subjects) or second dose (naive subjects) of rMenB+OMV NZ, to each and any one, two, three or all four indicator strains
F)Percentage of subjects with hSBA ≥1:5, hSBA ≥1:8, hSBA ≥1:16 and hSBA GMTs in naive subjects after 2 doses.
G) GMRs of GMTs in naive subjects after the second dose versus pre-vaccination.
H) Percentage of subjects with 4-fold rise pre-vaccination with a first dose compared to one month post-vaccination with a second dose (naïve subjects) to each and any one, two, three or all 4 indicator strains.

E.5.2.1

Timepoint(s) of evaluation of this end point

A) baseline (pre-boost) and 1 month after booster (follow-on subjects), baseline (pre first dose) and 1 month after first dose (naïve subjects)
B) one month post-booster dose versus pre-booster dose (follow-on subjects), first dose versus pre-first dose (naïve subjects)
C)+ D) +E) pre-booster and three, seven, thirty days after booster dose (follow-on subjects), 1 month after first dose and three, seven, thirty days after second dose (naive subjects)
F) baseline (pre-fisrt dose)and one month after 2 doses in naive subjects
G) one month post second dose versus pre-first dose (baseline) in naive subjects
H) baseline (pre-fisrt dose) and one months after second dose (naive subjects)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Different treatment schedule in naïve subjects

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

Australia

Canada

Chile

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

End of study is defined as the completion of the testing of such
biological samples, to be achieved no later than 8 months after collection of the last biological sample Visit 6

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

122

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

122

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

409

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

531

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	Canada

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