Clinical Trials Register

Summary
EudraCT Number:	2009-014493-18
Sponsor's Protocol Code Number:	B1971012(6108A1-2003-EU)
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-06-21
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

Czechia - SUKL

A.2

EudraCT number

2009-014493-18

A.3

Full title of the trial

A Phase 2, Randomized, Placebo-Controlled, Single-blind Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Administered in
Either 2- or 3-Dose Regimens in Healthy Subjects Aged ≥11 to <19 Years

A.3.1

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

A clinical trial to determine if the investigational MnB vaccine works when 2 or 3 doses of the vaccine is given to adolescents.

A.4.1

Sponsor's protocol code number

B1971012(6108A1-2003-EU)

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pfizer Inc.
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	Pfizer Inc
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	Pfizer Inc
B.5.2	Functional name of contact point	Clinical Trials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	235 E 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	+18007181021
B.5.5	Fax number	+13037391119
B.5.6	E-mail	ClinicalTrials.govCallCenter@pfizer.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	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	MnB rLP2086
D.3.2	Product code	Not Applicable
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MnB rLP2086 subfamily A
D.3.9.1	CAS number	n/a
D.3.9.2	Current sponsor code	n/a
D.3.9.3	Other descriptive name	n/a
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	120
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MnB rLP2086 subfamily B
D.3.9.1	CAS number	n/a
D.3.9.2	Current sponsor code	n/a
D.3.9.3	Other descriptive name	n/a
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	120
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	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Healthy volunteers (prevention of bacterial meningitis).

E.1.1.1

Medical condition in easily understood language

Prevention of Meningitis caused by N.meningitidis B bacteria.

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

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

Co-Primary Objectives:

To assess the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the third vaccination with bivalent rLP2086 vaccine among group 1 subjects.

To assess the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the third vaccination with bivalent rLP2086 vaccine among group 2 subjects.

E.2.2

Secondary objectives of the trial

To assess the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the second vaccination withbivalent rLP2086 vaccine, among group 3 subjects.

To describe the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, throughout the study (all groups).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
1.Evidence of a personally signed and dated informed consent document (ICD) indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
2.Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3.Male or female subject aged ≥11 and <19 years at the time of enrollment.
4.Available for the entire study period and can be reached by telephone.
5.Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
6.All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination. For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study.
7.Negative urine pregnancy test for female subjects.

E.4

Principal exclusion criteria

Subjects presenting with any of the following will not be included in the study:
1.Previous vaccination with any meningococcal serogroup B vaccine.
2.A previous anaphylactic reaction to any vaccine or vaccine-related component.
3.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
4.A known or suspected disease of the immune system or those receiving immunosuppressive therapy.
5.History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
6.Significant neurological disorder or history of seizure (excluding simple febrile seizure).
7.Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
8.Current chronic use of systemic antibiotics.
9.Participation in other studies during study participation. Participation in purely observational studies is acceptable.
10.Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
11.Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
12.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
13.Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
14.Subject is a direct descendant (e.g., child, grandchild or other family member) of study site or Pfizer personnel.
15.Subject is pregnant or breastfeeding.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint for the first co-primary objectives are the proportion of subjects achieving hSBA titer ≥ lower limit of quantitation (LLOQ), for each of the 4 primary strains, measured 1 month after the third vaccination with bivalent rLP2086 vaccine (as measured at visit 6) among group 1 subjects.

The primary endpoint for the second co-primary objectives are the proportion of subjects achieving hSBA titer ≥ LLOQ, for each of the 4 primary strains, measured 1 month after the third vaccination with bivalent rLP2086 vaccine (visit 6) among group 2 subjects.

E.5.1.1

Timepoint(s) of evaluation of this end point

One month after the third dose of bivalent rLP2086 (Groups 1 and 2).

E.5.2

Secondary end point(s)

The endpoint for the first of the secondary objectives is the proportion of subjects achieving hSBA titer ≥ LLOQ for each of the 4 primary strains, measured 1 month after the second vaccination with bivalent rLP2086 vaccine among group 3 subjects.
The testing strategy for the above hypothesis testing endpoints is described in Section 9.5
Additional secondary endpoints for descriptive purposes include the following:
1.hSBA geometric mean titers (GMT) for each of the 4 primary strains at each blood sampling time point;
2.Proportion of subjects with hSBA titer ≥ LLOQ, for each of the 4 primary strains, at each blood sampling time point;
3.Proportion of subjects with hSBA titers ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, ≥1:128 at each blood sampling time point.

E.5.2.1

Timepoint(s) of evaluation of this end point

One month after the second dose of bivalent rLP2086 (group 3) and at other timepoints detailed in E 5.2.

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

E.6.13.1

Other scope of the trial description

Tolerability, Immunogenicity

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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)

E.8.2.2

Placebo

Yes

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

Information not present in EudraCT

E.8.4

The trial involves multiple sites in the Member State concerned

Information not present in EudraCT

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

Yes

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

The end of the clinical phase of the study will be the last telephone contact (visit 7) to the last subject. At this time, sites will be closed out, the institutional review board/ independent ethics committee (IRB/IEC) will be informed, and no further Council for International Organizations of Medical Sciences (CIOMS) reports will be sent. For other purposes, the end of study will be last serology sample assayed.

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:

1524

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)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

190

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

1334

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

190

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

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Adolescent population

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1714

F.4.2.2

In the whole clinical trial

1714

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)

Patients revert to standard care once their participation in the study has ended.

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

2011-02-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Patient Information Sheet and consent form and procedure

Date of Ethics Committee Opinion

2010-12-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-09-18

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