Clinical Trials Register

Summary
EudraCT Number:	2014-004617-82
Sponsor's Protocol Code Number:	V59_50
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2014-11-07
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

2014-004617-82

A.3

Full title of the trial

A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Children, Adolescents and Adults in Russia

A.3.1

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

Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia

A.4.1

Sponsor's protocol code number

V59_50

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01725217

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	Novartis Vaccines and Diagnostics SRL
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 SRL
B.4.2	Country	Russian Federation
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Vaccines and Diagnostics SRL
B.5.2	Functional name of contact point	Posting Director
B.5.3	Address:
B.5.3.1	Street Address	Via Fiorentina
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	Yes
D.2.1.1.1	Trade name	Menveo
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Vaccines and Diagnostics SRL
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 solvent 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	MenA-CRM
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	MenC-CRM
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	MenW - CRM
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	MenY-CRM
D.3.9.3	Other descriptive name	N. MENINGITIDIS GROUP Y POLYSACCHARIDE
D.3.9.4	EV Substance Code	SUB26072
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.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

Prophylaxis against Neisseria meningitidis serogroups A, C, W, and Y

E.1.1.1

Medical condition in easily understood language

Prophylaxis against Neisseria meningitidis serogroups A, C, W, and Y

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 of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with hSBA seroresponse1, directed against N meningitidis serogroups A, C, W, and Y.

E.2.2

Secondary objectives of the trial

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with hSBA seroresponse1, directed against N meningitidis serogroups A, C, W, and Y by age group (2-10, 11-17, and 18 years and above).

To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA geometric mean titers (GMTs) and by the percentage of subjects with hSBA titer ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y, overall and by age group.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Individuals eligible for enrolment in this study were those
1. who were of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study was described and:
 the parent/legal representative had provided written informed consent (≥2 to <18years of age);
 had provided written assent (≥11 to <18 years of age);
 had provided written informed consent (≥18 years of age onwards).
2. who the investigator believed that the subject and/or his or her parent/legal representative could and would comply with the requirements of the protocol (eg, completion of the diary card, return for follow-up visit).
3. who were in good health as determined by:
 medical history;
 physical exam;
 clinical judgment of the investigator.
4. who had a negative urine pregnancy test for female subjects from 11 years of age.

E.4

Principal exclusion criteria

Individuals not eligible to be enrolled in the study were those:
1. who were unwilling or unable to give written informed assent or consent to participate
in the study;
2. who were perceived to be unreliable or unavailable for the duration of the study
period;
3. who had a previous confirmed or suspected disease caused by N meningitidis;
4. who had household contact with and/or intimate exposure to an individual with
culture-proven N meningitidis infection within 60 days prior to enrolment;
5. who had previously been immunized with a meningococcal vaccine or vaccine
containing meningococcal antigen(s) (licensed or investigational);
6. who were pregnant or breast feeding (female subjects);
7. who had received any investigational or nonregistered product (drug or vaccine)
within 28 days prior to enrolment or who expected to receive an investigational drug
or vaccine prior to the completion of the study;
8. who had received any vaccines within 14 days (for inactivated vaccines) or 28 days
(for live vaccines) prior to enrolment in this study or who were planning to receive
any vaccine within 30 days from the study vaccines (exception: Influenza vaccine may
be administered up to 15 days prior to study vaccination and at least 15 days after
study vaccination);
9. who had experienced within the 7 days prior to enrolment, a significant acute
infection (for example requiring systemic antibiotic treatment or antiviral therapy) or
had experienced fever (defined as body temperature 38°C) within 3 days prior to
enrolment;
10. who had any serious acute, chronic or progressive disease (eg, any history of
neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or
AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition) and who had epilepsy or any progressive neurological disease or history
of Guillain-Barre syndrome;
11. who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any
vaccine components including diphtheria toxin (CRM-197) and latex in the syringe;
12. who had a known or suspected impairment/alteration of immune function, either
congenital or acquired or resulting from (for example):
- receipt of immunosuppressive therapy within 30 days prior to enrolment (any
systemic corticosteroid administered for more than 5 days, or in a daily
dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to
enrolment, or cancer chemotherapy);
- receipt of immunostimulants;
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
derivatives within 90 days prior to enrolment and for the full length of the study.
13. who were known to have a bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time.

E.5 End points

E.5.1

Primary end point(s)

Percentage of subjects with hSBA seroresponse to N meningitidis serogroups A, C, W, and Y. Seroresponse was defined as a postvaccination hSBA ≥ 1:8 in subjects with a prevaccination hSBA < 1:4 and at least a 4-fold increase in postvaccination hSBA in subjects with prevaccination hSBA ≥ 1:4.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 29

E.5.2

Secondary end point(s)

Percentage of subjects with hSBA seroresponse to N meningitidis serogroups A, C,
W, and Y stratified by age group (≥2 to ≤10 years, ≥11-≤17 years, 18 years and
above) (seroresponse defined above).
- hSBA GMTs to N meningitidis serogroups A,C,W, and Y, overall and stratified by
age group (≥2-≤10 years, ≥11-≤17 years, 18 years and above).
- Percentage of subjects with hSBA ≥ 1:8 to N meningitidis serogroups A, C, W, and Y,
overall and stratified by age group (≥2-≤10 years, ≥11-≤17 years, 18 years and
above).

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 29

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

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

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

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

Russian Federation

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

LSLV

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:

132

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.2.1

Number of subjects for this age range:

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

198

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:	Russian Federation

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