Clinical Trials Register

Summary
EudraCT Number:	2014-004973-17
Sponsor's Protocol Code Number:	V59_49
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2014-11-18
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

2014-004973-17

A.3

Full title of the trial

A phase 3, multicenter, open-label study to evaluate immunogenicity and safety of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy subjects from 2 to 18 years in Taiwan.

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 Subjects From 2 to 18 Years in Taiwan.

A.4.1

Sponsor's protocol code number

V59_49

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01410474

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
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
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
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 s.r.l
D.2.1.2	Country which granted the Marketing Authorisation	Taiwan
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	Novartis Meningococcal ACWY Conjugate Vaccine
D.3.4	Pharmaceutical form	Powder and solution for solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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

Prophylaxis against Neisseria meningitidis serogroups A, C, W135 and Y

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 of a single injection of MenACWY-CRM as
measured by the percentage of subjects with hSBA seroresponse, directed against N meningitidis serogroups A, C, W135 and Y.

E.2.2

Secondary objectives of the trial

Immunogenecity Objectives

- To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with hSBA seroresponse, directed against N meningitidis serogroups A, C, W135 and Y by age group (2-10b, 11-18c
years).
- To assess the immunogenicity of a single injection of MenACWY-CRM as measured by hSBA geometric mean titers (GMTs and GMRd) and by the percentage of subjects with hSBA titer ≥ 1:8, directed against N meningitidis serogroups A, C, W135 and Y, overall and by age group.

Safety Objectives

To assess the safety profile following MenACWY-CRM vaccination in terms of percentages and numbers of subjects with:
- Local and systemic reactionse reported from day 1 (day of vaccination) through day 7 postvaccination.
- All other adverse eventsf (AEs) reported from day 1 through day 7
postvaccination.
- Serious AEs (SAEs), medically attended AEs and AEs resulting in premature withdrawal from day 1 through day 29.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Individuals eligible for enrollment in this study were those:
1. who were of any gender, from the age of ≥ 2 to ≤ 18 years of age at the time of visit 1, and to whom the nature of the study had been explained and
a. the parent/legal representative had provided written informed consent.
b. had provided written assent (≥ 7 to ≤ 18 years of age)
2. who the investigator believed that their parents/legal representatives would comply with the requirements of the protocol (e.g., completion of the diary card, return for the follow-up visit).
3. who were in good health as determined by
a. medical history
b. physical exam
c. clinical judgment of the investigator
4. who had a negative urine pregnancy test for female subjects ≥ 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 previously 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 vaccinated with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
6. who had received any investigational or non-registered 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.
7. 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 could be administered up to 15 days prior to study vaccination and at least 15 days
after study vaccination).
8. who had experienced within the 7 days prior to enrolment 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 enrollment.
9. who had any serious acute, chronic or progressive disease (e.g., 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), who had epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
10. who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
11. who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
a. received 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)
b. received immunostimulants.
c. received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrolment and for the full length of the study
12. who were known to have a bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time.
13. who had Down’s syndrome or other known cytogenic disorders.
14. who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

E.5 End points

E.5.1

Primary end point(s)

Percentage of subjects with hSBA seroresponse to N meningitidis serogroups A, C, W135 and Y at day 29 in the overall subjects (≥ 2 to ≤ 18 years of age).
Seroresponse is defined as:
-for subjects with a prevaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8.
-for subjects with a prevaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 1 and Day 29

E.5.2

Secondary end point(s)

Immunogenecity endpoint

-Percentage of subjects with hSBA seroresponse to N meningitidis serogroups A, C, W135 and Y at day 29 by age group (≥ 2 to ≤ 10 years and ≥ 11 to ≤ 18 years).
-hSBA GMTs to N meningitidis serogroups A, C, W135 and Y at day 1 and day 29, overall and by age group.
-hSBA geometric mean ratio (GMR) to N meningitidis serogroups A, C, W135 and Y, overall and by age group.
-Percentage of subjects with hSBA titer ≥ 1:8 to N meningitidis serogroups A, C, W135 and Y at day 1 and day 29, overall and by age group.

Safety Endpoints
-Numbers and percentages of subjects with reported solicited local and systemic AEs and unsolicited AEs.

E.5.2.1

Timepoint(s) of evaluation of this end point

Immunogenecity Objective -
Day 1 and Day 29

Safety objective -
Local and systemic reactions- Day 1 through Day 7 postvaccination.
Other adverse events- Day 1 through Day 7 postvaccination.
Serious AEs (SAEs), medically attended AEs and AEs- Day 1 through 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

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

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

Taiwan

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.8.9.2

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