Clinical Trials Register

Summary
EudraCT Number:	2016-005117-44
Sponsor's Protocol Code Number:	205240
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2017-03-10
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

2016-005117-44

A.3

Full title of the trial

A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of Novartis Meningococcal group B Vaccine When Administered Concomitantly with Novartis MenACWY Conjugate Vaccine to Healthy Infants

A.3.1

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

Safety and Immunogenicity of Novartis Meningococcal Group B Vaccine When Administered Concomitantly With Novartis MenACWY Conjugate Vaccine to Healthy Infants

A.3.2

Name or abbreviated title of the trial where available

MENB REC 2ND GEN-022 (V72_56)

A.4.1

Sponsor's protocol code number

205240

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	442089904466
B.5.6	E-mail	GSKClinicalSupportHD@gsk.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Menveo
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.3.4	Pharmaceutical form	Powder and solution for solution 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.3.9.3	Other descriptive name	N. MENINGITIDIS GROUP A OLIGOSACCHARIDE CONJUGATED CRM197
D.3.9.4	EV Substance Code	SUB31082
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	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	_
D.3.9.3	Other descriptive name	N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE CONJUGATED CRM197
D.3.9.4	EV Substance Code	SUB26743
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	_
D.3.9.3	Other descriptive name	N. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197
D.3.9.4	EV Substance Code	SUB31083
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	_
D.3.9.3	Other descriptive name	MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN
D.3.9.4	EV Substance Code	SUB126362
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	5
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	No
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.IMP: 2
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	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, Meningoccal)

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 immunological non-inferiority of rMenB+OMV NZ and MenACWY when concomitantly administered compared to either alone in healthy infants at 3, 5, 7 and 13 months of age, as measured by the ratio of hSBA Geometric Mean Titers (GMTs) against each of the serogroup B indicator strains (for rMenB+OMV NZ) and serogroups A, C, W-135 and Y (for MenACWY) at one month after the fourth vaccination.

Non-inferiority will be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ, and rMenB+OMV NZ + MenACWY versus MenACWY) is > 0.5 for all serogroup B indicator strains and all serogroups A, C, W-135 and Y.

E.2.2

Secondary objectives of the trial

• To assess the immune response of rMenB+OMV NZ and MenACWY:
- at one month after the fourth vaccination,
- at one month after the third vaccination,
- at six months after the third vaccination,
when concomitantly administered compared to either alone in healthy infants at 3, 5, 7 and 13 months of age.

• To assess the safety and tolerability of rMenB+OMV NZ and MenACWY when concomitantly administered, compared to either alone, in infants at 3, 5, 7 and 13 months of age.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained.
2. Available for all the visits scheduled in the study.
3. In good health as determined by medical history, physical examination and clinical judgment of the investigator.

E.4

Principal exclusion criteria

1. History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
2. Previous known or suspected disease caused by N. meningitidis.
3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
4. History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine.
5. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for example:
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth (3 months prior). (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. Inhaled and topical steroids are allowed),
- Immune deficiency disorder, or known HIV infection.
6. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth.
7. History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).
8. History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw.
9. Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
10. Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period.
11. Family members or household members of site research staff.
12. Any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down’s syndrome).
13. History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.

E.5 End points

E.5.1

Primary end point(s)

1) hSBA Geometric Mean Titers (GMTs) against each of the serogroup B indicator strains (for rMenB+OMV NZ) and serogroups A, C, W-135 and Y (for MenACWY)

2) Between-group ratios of GMTs for rMenB+OMV NZ + Men-ACWY versus rMenB+OMV NZ (serogroup B indicator strains), and rMenB+OMV NZ +MenACWY versus MenACWY (serogroups A, C, W-135 and Y); non-inferiority will be concluded if, at one month following the fourth vaccination, the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ, and rMenB+OMV NZ + MenACWY versus MenACWY) is > 0.5 for all serogroup B indicator strains and all serogroups A, C, W-135 and Y.

E.5.1.1

Timepoint(s) of evaluation of this end point

1) and 2): One month after the fourth vaccination

E.5.2

Secondary end point(s)

1) Evaluation of immune response of rMenB+OMV NZ by hSBA GMTs against each of the serogroup B indicator strains

2) Evaluation of immune response of rMenB+OMV NZ by per-centage of subjects with hSBA ≥1:5 and hSBA ≥1:8 against each of the serogroup B indicator strains

3) Evaluation of immune response by hSBA GMTs against each of the serogroups A, C, W-135 and Y

4) Evaluation of immune response by the percentage of subjects with hSBA ≥1:4 and subjects with hSBA ≥1:8 against each of the serogroups A, C, W-135 and Y

5) Within-subject Geometric Mean Ratios (GMRs) against each of the serogroup B indicator strains and each of the serogroups A, C, W-135 and Y

6) Percentage of subjects with four-fold increases in hSBA titers against each of the serogroup B indicator strains and each of the serogroups A, C, W-135 and Y

7) Frequencies and percentages of subjects with solicited local and systemic Adverse Events (AEs).

8) Frequencies and percentages of subjects with any other (unso-licited) AEs, AEs leading to withdrawal and medically attended AEs

9) Frequencies and percentages of subjects with SAEs, AEs leading to withdrawal and medically attended AEs

E.5.2.1

Timepoint(s) of evaluation of this end point

1), 2), 3), and 4): Before the first vaccination, one month after the third vaccination, before the fourth vaccination (13 months of age) and one month after the fourth vaccination

5) One month after the fourth vaccination versus pre-fourth vaccination

6) One month after the fourth vaccination over pre-fourth vaccination

7) and 8): 7 days (including the day of vaccination) after Day 1, 61, 121, and 301 for all Vaccine Groups

9) Throughout the study period (approximately 11 months)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

Argentina

Mexico

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 8.

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

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:

750

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

750

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

750

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:	Mexico

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