Clinical Trials Register

Summary
EudraCT Number:	2014-004410-29
Sponsor's Protocol Code Number:	V72P10
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2014-10-27
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

2014-004410-29

A.3

Full title of the trial

A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules

A.3.1

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

Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules

A.4.1

Sponsor's protocol code number

V72P10

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00661713

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/038/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Vaccines and Diagnostics S.r.l
B.1.3.4	Country	Italy
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	Novartis Vaccines and Diagnostics S.r.l
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Vaccines and Diagnostics S.r.l
B.5.2	Functional name of contact point	posting director
B.5.3	Address:
B.5.3.1	Street Address	via Fiorentina 1
B.5.3.2	Town/ city	Siena
B.5.3.3	Post code	53100
B.5.3.4	Country	Italy
B.5.6	E-mail	RegistryContactVaccinesUS@novartis.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	No
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	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	N meningitidis 961c purified antigen
D.3.9.3	Other descriptive name	RECOMBINANT NEISSERIA MENINGITIS GROUP B PROTEIN 961C
D.3.9.4	EV Substance Code	SUB126665
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	N meningitidis 936-741 purified antigen
D.3.9.3	Other descriptive name	RECOMBINANT NEISSERIA MENINGITIS GROUP B PROTEIN 936-741
D.3.9.4	EV Substance Code	SUB126666
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	N meningitidis ΔG287-953 purified antigen
D.3.9.3	Other descriptive name	RECOMBINANT NEISSERIA MENINGITIDIS GROUP B PROTEIN 287-953
D.3.9.4	EV Substance Code	SUB126662
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	OMV from N meningitidis Strain NZ 98/254
D.3.9.3	Other descriptive name	OUTER MEMBRANE VESICLES FROM NEISSERIA MENINGITIDIS GROUP B (STRAIN NZ 98/254)
D.3.9.4	EV Substance Code	SUB77057
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	Yes
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.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prophylaxis against invasive meningococcal disease

E.1.1.1

Medical condition in easily understood language

Meningococcal Disease

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 the immunogenicity, safety and tolerability of one, two (0,1 or 0,2 schedule) or three doses (0, 1, 2 schedule) of Novartis rMenB+OMV NZ in healthy adolescents, by evaluation of the serum bactericidal activity using human complement (SBA) response at one month after the last rMenB+OMV NZ dose.

E.2.2

Secondary objectives of the trial

To assess the immunogenicity, safety and tolerability of an additional dose of Novartis rMenB+OMV NZ given at Month 6, by evaluation of the serum bactericidal activity using human complement (SBA) response at one month after the month 6 rMenB+OMV NZ dose, for schedules 0; 0,1 and 0,2.

To assess the antibody persistence following various vaccination schedules.of one, two (0,1 or 0,2 schedule) or three doses (0, 1, 2 schedule) of Novartis rMenB+OMV NZ.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. 11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment.

2. who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period).

3. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

E.4

Principal exclusion criteria

1. History of any meningococcal B vaccine administration.

2. Current or previous, confirmed or suspected disease caused by N. meningitidis.

3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment.

4. Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day.

5. Antibiotics within 6 days prior to enrollment.

6. Pregnancy or nursing (breastfeeding) mothers.

7. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 7 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry.

8. Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).

9. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants.

10. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days.

11. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component.

12. Receipt of or intent to immunize with any other vaccine(s) within 30 days prior (60 days for live viral vaccines) and throughout the study period (exception: licensed fluvaccine should not be administered within 14 days prior to enrollment; routine vaccine administration may be administered after the blood draw at Study Month 7).

13. Participation in another clinical trial within the last 90 days or planned for during study.

14. Family members and household members of research staff.

15. Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.

E.5 End points

E.5.1

Primary end point(s)

Percentage of subjects with a SBA titer ≥1:4 will measured at baseline, Month 1, Month 2, Month 3 for each meningococcal B strain.

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline, Month 1, Month 2, Month 3;

E.5.2

Secondary end point(s)

1. Percentage of subjects with a SBA titer ≥1:4 will be measured at Month 6 and Month 7 for each meningococcal B strain.

2. Percentage of subjects with a SBA titer ≥1:8 will be measured at baseline, Month 1, Month 2, Month 3, Month 6 and Month 7 for each meningococcal B strain.

3. Percentage of subjects with at least a fourfold rise in SBA titer over the prevaccination titer will be measured for meningococcal B strain at Month 1, Month 2, Month 3, Month 6 and Month 7.

4. Adjusted geometric mean titers (GMTs), geometric mean ratios (GMRs will be calculated for meningococcal B strain at each visit.

5. Unadjusted geometric mean titers (GMTs) will be measured for group 5 at visit 6.

6. Serious adverse events and all other AEs including local and systemic reactions data is collected throughout the study.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Month 6 & month 7;

2. Baseline, Month 1, Month 2, Month 3, Month 6 and Month 7;

3. Month 1, Month 2, Month 3, Month 6 and Month 7;

4. at each visit;

5. at visit 6;

6. Throughout the study;

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

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

Yes

E.6.13.1

Other scope of the trial description

Immunogenecity

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

E.8.2.2

Placebo

Yes

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

Chile

E.8.7

Trial has a data monitoring committee

Yes

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 Trial corresponds to the last visit of the last subject undergoing the trial (LSLV, Last Subject Last Visit).

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:

1625

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)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

1625

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

1625

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:	Chile

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