Clinical Trials Register

Summary
EudraCT Number:	2011-004400-38
Sponsor's Protocol Code Number:	B1971035
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:	2015-04-14
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

2011-004400-38

A.3

Full title of the trial

A Phase 2, Randomized, Controlled, Observer-blinded Study, Conducted to Describe the Immunogenicity, Safety, and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) when Administered to Healthy Toddlers Aged 12 to <18 Months or 18 to <24 Months, and the Safety and Immunogenicity of a
Booster Dose of bivalent rLP2086

Randomizovaná, kontrolovaná, pro pozorovatele zaslepená studie fáze 2 prováděná za účelem popisu imunogenicity, bezpečnosti a snášenlivosti meningokokové vakcíny séroskupiny B (Neisseria Meningitidis) z bivalentního rekombinantního lipoproteinu 2086 (bivalentní rLP2086) podané zdravým batolatům ve věku 12 až < 18 měsíců nebo 18 až < 24 měsíců, a bezpečnosti a imunogenicity posilovací dávky bivalentní rLP2086

A.3.1

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

A study to find out if a vaccine designed to protect against a disease (group B meningococcal meningitis) is safe and protects toddlers aged 12 <18months or 18 < 24 months.

A.4.1

Sponsor's protocol code number

B1971035

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/093/2013

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, 235 East 42nd Street, New York, NY 10017
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	0018007181021
B.5.5	Fax number	0013037391119
B.5.6	E-mail	ClinicalTrials.gov.CallCenter@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	Yes
D.2.1.1.1	Trade name	Trumenba suspension for injection in pre-filled syringe
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Ltd
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	Bivalent rLP2086 vaccine
D.3.2	Product code	PF-05212366
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.3.9.4	EV Substance Code	SUB31503
D.3.10	Strength
D.3.10.1	Concentration unit	µg/µl microgram(s)/microlitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	60 to 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.3.9.4	EV Substance Code	SUB31504
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	60 to 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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	VAQTA Paediatric
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur MSD Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	Yes
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	N/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	Inactivated Hepatitis A virus (strain CR 326F)
D.3.9.4	EV Substance Code	SUB42087
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	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

Invasive meningococcal disease (IMD) caused by Neisseria meningitidis
serogroup B

E.1.1.1

Medical condition in easily understood language

Group B meningococcal disease (e.g. meningitis)

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10027249
E.1.2	Term	Meningitis meningococcal
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

•To describe the immune response as measured by hSBA performed with 4 primary MnB strains, 2 expressing an LP2086 subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after the third vaccination with bivalent rLP2086 vaccine, in healthy toddlers aged 12 to <18 months at study entry.

•To describe the immune response as measured by hSBA performed with 4 primary MnB strains, 2 expressing an LP2086 subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after the third vaccination with bivalent rLP2086 vaccine, in healthy toddlers aged 18 to <24 months at study entry.
See protocol for Primary Safety Objective.

E.2.2

Secondary objectives of the trial

To describe the immune response as measured by hSBA performed with 4 primary MnB test strains, 2 expressing an LP2086 subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after the third vaccination with bivalent rLP2086 vaccine, in healthy toddlers aged 12 to < 24 months at study entry (i.e., both age strata combined).

To describe the immune response as measured by hSBA performed with 4 primary MnB test strains, 2 expressing an LP2086 subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after the second vaccination, and 6, 12, 24, 36, and 48 months after the third vaccination in healthy toddlers aged 12 to <18 months and 18 to <24 months at study entry, and in both age strata combined.
See protocol for Secondary Safety Objective.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

1.Evidence of a personally signed and dated informed consent document (ICD) indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study (a parent(s)/legal guardian must be over 18 years old to consent for the child to be considered for inclusion in this study).

2.Subject must have received all vaccinations in the relevant national immunization program (NIP) for his or her age group.

3.Male or female subject aged:

•12 to <15 months or 18 to <24 months during sentinel-cohort enrollment.

•12 to <24 months during expanded-cohort enrollment

4.Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.

5.Subject’s parent(s)/legal guardian is willing and able to comply with the child’s scheduled visits, vaccination regimen, laboratory tests, and other study procedures.

6.Subject is available for the entire study period and his or her parent(s)/legal guardian can be reached by telephone.

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.Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.

3.Contraindication to vaccination with any HAV vaccine or known latex allergy.

4.Receiving any allergen immunotherapy.

5.A previous anaphylactic reaction to any vaccine or vaccine-related component.

6.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

7.A known or suspected disorder of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B-cell function or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included. Please refer to the study reference manual (SRM) for additional details.

8.History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.

9.Significant neurologic disorder or history of seizure (excluding simple febrile seizure).

10.Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.

11.Current chronic use of systemic antibiotics.

12.Current participation in another investigational study. Participation in purely observational studies is acceptable.

13.Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.

14.Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

15.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.

16.Subjects who are children of investigational site staff members or relatives of those site staff members or subjects who are children of Pfizer employees directly involved in the conduct of the study.

E.5 End points

E.5.1

Primary end point(s)

• Proportions of subjects achieving an hSBA titer ≥the lower limit of quantation (LLOQ) 1 month after the third vaccination, for each of the 4 primary MnB test strains in healthy toddlers aged 12 to <18 months at study entry.

• Proportions of subjects achieving an hSBA titer ≥ LLOQ 1 month after the third vaccination, for each of the 4 primary MnB test strains in healthy toddlers aged 18 to <24 months at study entry.

E.5.1.1

Timepoint(s) of evaluation of this end point

Time points for Primary End Points are included in Section E.5.1 of this form.

E.5.2

Secondary end point(s)

The following endpoints will be applied to results In healthy subjects aged 12 months to <24 months (i.e., both age strata combined) at study entry:
• Proportion of subjects with hSBA titer ≥LLOQ for each of the 4 primary MnB test strains 1 month after the third vaccination with bivalent rLP2086.
• Proportions of subjects with hSBA titers ≥ LLOQ, ≥1:4, ≥1:8, ≥1:16, ≥
1:32, ≥1:64, and ≥1:128 for each of the 4 primary strains 1 month after the third vaccination, before the booster vaccination (Visit 12), and 1 month following booster vaccination (Visit 13).
• hSBA GMTs for each of the 4 MnB primary strains 1 month after the third vaccination, before the booster vaccination (Visit 12), and 1 month following booster vaccination (Visit 13).The following endpoints will be applied to results in healthy subjects aged 12 to <18 months or 18 to <24 months at study entry and in both age strata combined:
• Proportions of subjects with hSBA titers ≥ LLOQ for each of the 4 primary MnB test strains 1 month after the second vaccination with bivalent rLP2086 and 6, 12, and 24 months after the third vaccination with bivalent rLP2086.
•Proportions of subjects with hSBA titers ≥ LLOQ, ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for each of the 4 primary MnB strains 1 month after thesecond vaccination and 1, 6, 12, and 24 months after the third vaccination.
• hSBA GMTs for each of the 4 primary test strains 1 month after the second vaccination and 1, 6, 12, and 24 months after the third vaccination.

E.5.2.1

Timepoint(s) of evaluation of this end point

Timepoints for the Secondary end points are inlcuded in Section E.5.2 of this form.

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

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

Immunogenicity & Tolerability

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

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

Observer Blinded (Stage 1); Open-Label (Stage 2)

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Czech Republic

Poland

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

In a Member State of the EU it is defined as the time at which it is deemed that a sufficient number of subjects have been recruited and completed the study as stated in the regulatory application and ethics application in the Member State. Poor recruitment by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.

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

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:

396

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

396

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

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

Yes

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

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

Subjects will be aged 12 to <18 Months or 18 to <24 Months. Voluntary, written study-specific informed consent will be obtained from the subjects parent(s)/legal guardian who must be, at the time of consent, at least 18 years of age.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

312

F.4.2.2

In the whole clinical trial

396

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)

N/A

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

2015-05-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-03-17

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