Clinical Trials Register

Summary
EudraCT Number:	2014-004446-95
Sponsor's Protocol Code Number:	V59P20E1
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2014-11-13
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

2014-004446-95

A.3

Full title of the trial

A Phase IV, open-label, controlled, multi-center study to evaluate the 5-year antibody persistence among children who previously received Novartis MenACWY conjugate vaccine at 2 to 10 years of age and to assess the immune response to a single dose of Novartis MenACWY conjugate vaccine.

A.3.1

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

This is an extension study, V59P20E1 of V59P20,in which the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination.

A.4.1

Sponsor's protocol code number

V59P20E1

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01823536

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	United States
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
B.4.2	Country	United States
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	Novartis Vaccines and Diagnostics
B.5.3	Address:
B.5.3.1	Street Address	350 Massachusetts Avenue
B.5.3.2	Town/ city	Massachusetts
B.5.3.3	Post code	02139
B.5.3.4	Country	United States
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	Not Applicable
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	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

Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose.

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 evaluate the persistence of the antibody response at 5 years postvaccination in children who previously received one or two doses of MenACWY in study V59P20, as measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.

E.2.2

Secondary objectives of the trial

Evaluating antibody persistence at 5 years postvaccination in subjects who previously received one or two doses of MenACWY-CRM in study V59P20, as measured by hSBA geometric mean titers (GMTs) directed against N meningitidis serogroups A, C, W-135, and Y.
Comparing antibody titers between children vaccinated 5 years earlier with one or two doses of MenACWY and the vaccine-naive subjects in the same age group as measured by percentages of subjects with hSBA ≥1:8.
Evaluating antibody response to one dose of MenACWY in children who received one or two doses of the same vaccine 5 years earlier (V59P20), as measured by percentage of subjects with hSBA ≥1:8, and GMTs at 28 days postvaccination.
Comparing the antibody response to one dose of MenACWY in children who received one or two doses of the same vaccine 5 years earlier in study V59P20 and in vaccine-naive subjects in the same age group, as measured by percentage of subjects with hSBA ≥1:8, and GMTs at 28 days postvaccination.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject has (a) parent(s) or legal guardian(s) who has/have given written consent after the nature of the study has been explained according to local regulatory requirements.
2. If the subject is of an age where, according to local regulations, informed assent is required, that subject has provided assent to participate in the study.
3. Subject is in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator.
4. A negative urine pregnancy test is required before female subjects of childbearing potential will be enrolled.
- Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
5. For subjects who participated in study V59P20 (Groups A, B and D only): subject who enrolled in Groups I, II or IV of study V59P20, has completed this study and included in per protocol immunogenicity analysis; the date of first vaccination in study V59P20 occurred 54 to 66 months prior to the collection of the blood sample at Visit 1.
6. For vaccine-naive subjects (Groups C and E only): Individual is a male or female 7 to 10 years of age (group C) or 11 to 15 years of age (Group E).

E.4

Principal exclusion criteria

1. If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.(Acceptable birth control methods were defined as one or more of the following: hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring), barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse, intrauterine device (IUD), monogamous relationship with vasectomized partner (partner was to be vasectomized for at least six months prior to the subject’s study entry) and abstinence.)
2. Subject is a pregnant or breast-feeding female.
3. Subjects’ parents or legal guardians or subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study.
4. History of documented or suspected invasive meningococcal disease.
5. Previous household contact with and/or intimate exposure to an individual with laboratory proven N. meningitidis infection within 60 days prior to enrollment and for the duration of the study.
6. Have received any other meningococcal vaccine since participation in V59P20 or, if vaccine-naive subjects, have received any meningococcal vaccine since birth.
7. Suspected or known hypersensitivity reaction after a previous dose of Menveo, any component of this vaccine, including any other CRM197 and diphtheria toxoid.
8. Any contraindication or precaution against vaccination with Novartis Menveo™ vaccine as highlighted in the package insert.
9. Serious, chronic, or acute illnesses or diseases (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system).
10. Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
11. Administration of any cancer chemotherapy, immune-modified or immunosuppressive agents or systemic corticosteroids for at least seven days at any dose in the past 12 weeks or planned use throughout the study period (topical, inhaled, and intranasal corticosteroids are permitted).
12. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks or planned use throughout the study period.
13. Administration of any vaccine within 28 days prior to the study enrollment or planned administration during the study period.
14. Subjects participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the study period.
15. Subjects who have experienced a significant acute infection requiring systemic antibiotic treatment within the 5 days prior to enrolment or have experienced a body temperature ≥38°C (≥100.4°F) within the 3 days before the intended study vaccination.
16. Any condition which, in the opinion of the investigator, would pose a health risk to the participant.

E.5 End points

E.5.1

Primary end point(s)

Primary Endpoint(s)
▫ Percentage of subjects with hSBA ≥1:8 in groups who previously received one or two doses of MenACWY vaccine (Groups A, B and D) on Day 1.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 1

E.5.2

Secondary end point(s)

Secondary Immunogenicity Endpoints
▫ hSBA GMTs against N. meningitidis serogroups A, C, W-135 and Y on Day 1.
▫ Percentage of subjects with hSBA ≥1:8 in vaccine-naive subjects (Groups C and E) on Day 1.
▫ Percentage of subjects with hSBA ≥1:8 on Day 28 postvaccination.
▫ hSBA GMTs against N. meningitidis serogroups A, C, W-135 and Y on Day 28 postvaccination.
Safety Endpoints
The safety and reactogenicity of MenACWY-CRM were assessed in all subjects in terms of the percentages of subjects reported AEs including:
-Solicited local and systemic AEs reported from day 1 through day 7 postvaccination;
-All unsolicited AEs reported from day 1 through day 28 postvaccination;
-Any AEs resulting in premature withdrawal from the study during the entire study period;
-All SAEs reported during the entire study period.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day1 and Day28

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

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

Yes

E.8.2.3.1

Comparator description

Subjects who had not previously received MenACWY vaccine were enrolled as controls in this study

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

United States

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