Clinical Trials Register

Summary
EudraCT Number:	2013-000145-39
Sponsor's Protocol Code Number:	V59_66
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Temporarily Halted
Date on which this record was first entered in the EudraCT database:	2013-05-02
Trial 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
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-000145-39

A.3

Full title of the trial

A Phase 3, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine, administered to Healthy Toddlers 12 Months of Age, Compared to Single Dose of Meningococcal C Conjugate Vaccine

A.3.1

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

A.4.1

Sponsor's protocol code number

V59_66

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 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	Laura Lulli
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.5.4	Telephone number	390577539177
B.5.5	Fax number	390577278600
B.5.6	E-mail	laura.lulli@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 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	Menveo
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.3.11 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	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	Meningitec
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Meningitec
D.3.4	Pharmaceutical form	Suspension for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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

To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine
given to healthy toddlers, as measured by the percentage of subjects with serum
bactericidal assay using human complement (hSBA) titers ≥8 against N.
meningitidis serogroup C, at 28 days after the vaccination.

E.1.1.1

Medical condition in easily understood language

To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine given to healthy toddlers.

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10027202
E.1.2	Term	Meningitis bacterial
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Immunogenicity objectives
1.To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine
given to healthy toddlers, as measured by the percentage of subjects with serum
bactericidal assay using human complement (hSBA) titers ≥8 against N.
meningitidis serogroup C, at 28 days after the vaccination.

Safety objectives:
1. To assess the safety and reactogenicity of MenACWY and MenC vaccines.

E.2.2

Secondary objectives of the trial

1 Assess immunogenicity of 1 dose of MenACWY, as measured by the % of subj. with hSBA titers ≥8 against N.meningitidis serogr. A, W and Y, at 28 days post vacc.
2 Assess and compare immunogenicity of 1 dose of MenACWY to that of MenC as measured by the % of subj. with hSBA seroresponse against N.meningitidis serogr. C, at 28 days post vacc.
3 Assess and compare immunogenicity of 1 dose of MenACWY to that of MenC as measured by hSBA geometric mean titers (GMTs) against N.meningitidis serogr. C, at 28 days post vacc.
4 Assess immunogenicity of 1 dose of MenACWY, as measured by the % of subj. with seroresponse and by hSBA GMTs against N.meningitidis serogr. A, W and Y, at 28 days post vacc.
5 Assess immunogenicity of 1 dose of MenACWY and 1 dose of MenC, as measured by the % of subj. with serum bactericidal assay using rabbit complement rSBA titers≥8, the % of subj. with rSBA titers≥128 and by rSBA GMTs against N.meningitidis serogr. A,C,W,Y at 28 days post vacc. (in subset of subj.)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria
described.
1. Male and female children between 12 months and 15 months old inclusive (minimum
365 days of age and maximum 15 months plus 29 days of age), who were born with
an estimated gestational age ≥ 37 weeks;
2. For whom parent(s)/legal guardian(s) have given written informed consent after the
nature of the study has been explained according to local regulatory requirements;
3. Who the investigator believes that their parents/ guardians will be available for all the
visits and would comply with the requirements of the protocol (e.g., completion of the
Diary Cards, availability for study visits / safety phone calls);
4. Individuals in good health as determined by the outcome of medical history, physical
examination and clinical judgment of the investigator;

E.4

Principal exclusion criteria

described.
1. Subjects that had a previous confirmed or suspected disease caused by N.
meningitidis.
2. Who were previously exposed to clinically proven meningococcal disease or clinical
bacterial meningitis without further microbiologic characterization, i.e. possible
meningococcal disease.
3. Who have previously been immunized with a meningococcal vaccine or vaccine
containing meningococcal antigen(s) (licensed or investigational).
4. Who have received within 90 days prior to enrolment or are expected to receive
during the study period any investigational or non-registered product (drug or
vaccine).
5. Who have received or who are planning to receive any vaccines within 14 days before
and 30 days after administration of the study vaccine (Exception: Injectable influenza
vaccine may be administered up to 14 days prior to study vaccination and at least 14
days after study vaccination).
6. Who have a major congenital defect or a serious chronic disease.
7. Who have a history of any anaphylaxis, severe vaccine reactions, or allergy to any
vaccine components including diphtheria toxoid (CRM197) and latex.
8. Who required chronic administration (defined as more than 14 days) of
immunosuppressants or other immune-modifying drugs within six months prior to
the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥
0.5 mg/kg/day. Inhaled and topical steroids are allowed).
9. Who received immunoglobulins and/or any blood products within 90 days prior study
vaccination or who have administration planned during the study period.
10. Who have any confirmed or suspected immunosuppressive or immunodeficient
condition, based on medical history and physical examination.
11. Who have any bleeding disorder which consider as a contraindication to intramuscular
injection or blood draw.
12. Who have experienced a significant acute infection or fever (defined as temperature ≥
38°C) within 3 days prior enrolment.
13. Who have received systemic antibiotic treatment within 7 days prior to enrolment.

There may be instances when individuals meet all entry criteria except one that relates to
transient clinical circumstances (e.g., body temperature elevation or recent use of
excluded medication or vaccine). Under these circumstances, a subject may be considered
eligible for study enrollment if the appropriate window for delay has passed,
inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be
eligible.

E.5 End points

E.5.1

Primary end point(s)

Primary Immunogenicity Endpoint
- Percentage of subjects with hSBA ≥1:8 against serogroup C at Day 30 post vaccination.

Safety Endpoints
Safety data will be summarized by vaccination group:
- Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after
vaccination

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

- Percentage of subjects with hSBA titers ≥8 against serogroups A, W and Y at Day 29
post vaccination.
- Percentage of subjects with hSBA seroresponse[1] against serogroups A, C, W and Y
at Day 29 post vaccination.
- hSBA GMTs for serogroups A, C, W and Y at Day 29 post vaccination.
- Percentage of subjects with rSBA titer ≥8 against serogroups A, C, W and Y at Day
29 post vaccination.
- Percentage of subjects with rSBA titers ≥128 against serogroups A, C, W and Y at
Day 29 post vaccination.
- rSBA GMT for serogroups A, C, W and Y at Day 29 post vaccination.

E.5.2.1

Timepoint(s) of evaluation of this end point

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

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

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

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

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:

1000

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:

1000

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.4.1

In the member state

300

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1000

F.4.2.2

In the whole clinical trial

1000

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

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-07-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-06-07

P. End of Trial
P.	End of Trial Status	Temporarily Halted

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials