Clinical Trials Register

Summary
EudraCT Number:	2009-018101-52
Sponsor's Protocol Code Number:	V72P13E2
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-04-01
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

Finland - Fimea

A.2

EudraCT number

2009-018101-52

A.3

Full title of the trial

Title of the trial: A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

A.4.1

Sponsor's protocol code number

V72P13E2

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	No
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 B Recombinant+OMV NZ vaccine
D.3.4	Pharmaceutical form	Suspension 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	N. meningitidis 961c purified antigen
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	N. meningitidis 936-741 purified antigen
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	N. meningitidis 287-953 purified antigen
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	N. meningitidis Outer membrane vescicles (OMV) from NZ strain
D.3.10	Strength
D.3.10.1	Concentration unit	µl/ml microlitre(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Information not present in EudraCT
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Groups 1a, 1b, 2a and 2b:
From the last study visit in V72P13E1 to the start of the study V72P13E2 (Day 1):assessment of immunogenicity or safety
Group 3:
From birth to the start of the study V72P13E2 (Day 1), 30 minutes after each vaccination:Immediate reactions, For 7 days after each vaccination: body temperature

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

Immunogenicity :To explore antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ, administered at 12 months of age to toddlers enrolled in study V72P13E1 who previously received a three-dose primary series of rMenB+OMV NZ (administered at 2, 4 and 6 months of age) as infants in the original parent study V72P13. Safety:a.To assess the safety and tolerability of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to toddlers at either 12 and 14 or 13 and 15 months of age in study V72P13E1.plus assess the safety and tolerability of two catch-up doses of rMenB+OMV NZ administered to naïve children at 24 and 26 months of age.

E.2.2

Secondary objectives of the trial

a. explore antibody persistence at one year after two catch-up doses previously administered to 12, 14 or 13,15 months of age in study V72P13E1.
b.characterize the antibody response to a booster (third) dose administered at one year after two catch-up doses previously administered to 12,14 or 13,15 months of age in study V72P13E1.
•explore antibody persistence at 6 months after a booster (third) dose adm. one year after two catch-up doses of rMenB+OMV NZ in the second year of life.
c.To characterize the antibody response to two catch-up doses of rMenB+OMV NZ administered to naïve children at 24 and 26 months of age.
•To explore antibody persistence at 6 months after two catch-up doses of rMenB+OMV NZ administered to naïve children at 24 and 26 months of age

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Group 3:naive subjects:Healthy male and female children, 23 to 27 months of age;
2. For whom parent(s)/legal guardian(s) have given written informed consent
3. Available for all the visits scheduled in the study;4. In good health
Groups 1a, 1b, 2a and 2b follow-on participants:
1. Healthy children who have participated in the immunogenicity part of V72P13E1 and have received their last vaccination 12 months (-30/+60 days) before enrollment in V72P13E2.
2. Who have received all vaccinations with rMenB+OMV NZ in V72P13 and
V72P13E1
3. Who have provided at least the blood sample one month after their fourth dose of
rMenB+OMV NZ (Groups 1a/1b) or after their second dose of rMenB+OMV NZ
(Groups 2a/2b) in V72P13E1 according to the protocol.
see protocol page 44

E.4

Principal exclusion criteria

Exclusion Criteria for naïve subjects newly enrolled (Group 3):
1. Subjects whose parent(s)/legal guardian(s) are unwilling or unable to give written
informed consent to participate in the study;
2. History of any meningococcal B vaccine administration;
3. Previous ascertained or suspected disease caused by N. meningitidis;
4. Household contact with and/or intimate exposure to an individual with laboratory
confirmed N. meningitidis;
5. History of severe allergic reaction after previous vaccinations or hypersensitivity to
any vaccine component
6. Significant acute or chronic infection within the previous 7 days or axillary
temperature >= 38Centigrade within the previous day;
7. Antibiotics treatment within 6 days prior to enrollment; for other point see protocol page 44
Exclusion Criteria for follow-on participants (Groups 1a, 1b, 2a and 2b):
Exclusion criteria are the same as for the naïve subjects (Group 3), with the exception of
criterion 2 which does not apply to these previously vaccinated subjects.

E.5 End points

E.5.1

Primary end point(s)

Immunogenicity Endpoints
Primary: Serum bactericidal activity B indicator strains H44/76, 5/99 and NZ98/254. Antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ (Groups 1a and 1b) will be assessed bycalculating SBA geometric mean titers (GMTs) and the percentage of subjects . Antibody responses to vaccine
antigen 287-953 will be determined by ELISA and summarized by geometric mean
concentrations (GMCs).
Safety Endpoints :All subjects who receive at least one dose of rMenB+OMV NZ investigational vaccine in this study and who provide any post-vaccination safety data will be included in the safety and tolerability analyses. All safety analyses will be descriptive.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

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

Yes

E.8.1.7.1

Other trial design description

A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1

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.8.3

The trial involves single site in the Member State concerned

Information not present in EudraCT

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

Information not present in EudraCT

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

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.1.1.1	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.1.1.6	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	440
F.4.2	For a multinational trial
F.4.2.1	In the EEA	940
F.4.2.2	In the whole clinical trial	940

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

2010-05-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-04-12

P. End of Trial
P.	End of Trial Status	Completed

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