Clinical Trials Register

Summary
EudraCT Number:	2011-004421-27
Sponsor's Protocol Code Number:	V59_57
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-11-22
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
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2011-004421-27

A.3

Full title of the trial

A Phase 3b, Randomized, Open-label, Multi-Center Study Assessing Immunogenicity, Safety and 1 Year Persistence of Antibodies after One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, administered to Healthy Children 2 to 10 years of age.

III.b. fázisú, randomizált, nyílt, multicentrikus vizsgálat az immunogenitás, a biztonságosság és az ellenanyagok 1 éves perzisztenciájának értékelésére, egy vagy két adag Novartis Meningococcus ACWY konjugált oltóanyag, 2-10 éves egészséges gyermekeknél történő alkalmazása után.

A.3.1

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

Több vizsgálóhelyre tervezett klinikai vizsgálat az immunogenitás, a biztonságosság értékelésére egy vagy két adag agyhártyagyulladás elleni Novartis (Meningococcus ACWY) oltóanyag, 2-10 éves egészséges gyermekeknél történő alkalmazása után.

A.4.1

Sponsor's protocol code number

V59_57

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
B.5.2	Functional name of contact point	Information Desk
B.5.3	Address:
B.5.3.1	Street Address	Bartók Béla 43-47
B.5.3.2	Town/ city	Budapest
B.5.3.3	Post code	1114
B.5.3.4	Country	Hungary
B.5.4	Telephone number	3612792552
B.5.5	Fax number	3612792559

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.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

Study to asses immunogenicity, safety and 1 year persistence of antibodies after one or two doses of Novartis Meningococcal ACWY Conjugate Vaccine, administered to healthy children 2 to 10 years of age.

E.1.1.1

Medical condition in easily understood language

Study to asses immunogenicity, safety and 1 year persistence of antibodies after one or two doses of Menveo in healthy children 2 to 10 years of age.

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	14.0
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:
Primary
1. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children 2 to 5 years of age, as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination.
2. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children 6 to 10 years of age, as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination.
Safety objectives:
•All adverse events (AEs) reported during days 1 to 7 after each vaccination;
•All medically attended AEs reported from study day 1 to study termination/early termination;
•All Serious adverse events (SAEs) reported from study day 1 to study

E.2.2

Secondary objectives of the trial

Immunogenicity objectives:
Secondary
1. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children in two age cohorts (2 to 5 and 6 to 10 years of age), as measured by the percentage of subjects with hSBA ≥1:8 and hSBA GMTs, directed against N. meningitidis serogroups A, C, W and Y (overall, and stratified according to a pre-vaccination hSBA <1:4 or ≥1:4), at 1 month after last vaccination.
2. To assess the immunity against N. meningitidis serogroups A, C, W and Y at 12 months after either one or two doses (given 2 months apart) of MenACWY-CRM vaccine, when administered to healthy children in two age cohorts (2 to 5 and 6 to 10 years of age), as measured by the percentage of subjects with hSBA ≥1:8 and by hSBA GMTs (overall, and stratified according to a pre-vaccination hSBA <1:4 or hSBA ≥1:4).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria: Children from 2 to 10 years of age with up to date routine childhood vaccination (to the best knowledge of subjects’ parents/legal representatives), generally in good health, and available for all study visits, whose legally acceptable representative has given written informed consent at the time of enrollment.

E.4

Principal exclusion criteria

Exclusion criteria: Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with meningococcal any vaccine. Exposure within 60 days to individuals with culture proven meningococcal disease.

E.5 End points

E.5.1

Primary end point(s)

All immunogenicity endpoints refer to each N. meningitidis serogroups A, C, W, Y.
Primary:
Percentage of subjects with hSBA seroresponse, defined as:
• for subjects with pre-vaccination hSBA <1:4, post vaccination hSBA ≥1:8
• for subjects with pre-vaccination hSBA ≥1:4, an increase of at least four times of the pre-vaccination hSBA.
• Safety will be assessed for all subjects in terms of the frequency and percentage of reported adverse events (AEs), medically attended AEs and serious adverse events (SAEs).
- All AEs will be collected for 7 days following each administration of the study vaccine.
- Medically attended AEs, AEs resulting in premature withdrawal from the study and SAEs will be collected from the time the subject signs the informed consent until he/she stops study participation.

E.5.1.1

Timepoint(s) of evaluation of this end point

one month and one year after last vaccination

E.5.2

Secondary end point(s)

Secondary:
• Percentage of subjects with hSBA ≥1:8.
• hSBA GMTs.
Safety Endpoints

E.5.2.1

Timepoint(s) of evaluation of this end point

one month and one year after last vaccination

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

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)

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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 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:	400
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	Yes
F.1.1.5.1	Number of subjects for this age range:	400
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	No
F.1.3	Elderly (>=65 years)	No
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	No
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	400

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

2012-01-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-05-30

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