Clinical Trials Register

Summary
EudraCT Number:	2011-005697-31
Sponsor's Protocol Code Number:	B1971033
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:	2012-03-12
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

2011-005697-31

A.3

Full title of the trial

A PHASE III STUDY, TO ASSESS THE PERSISTENCE OF hSBA RESPONSE UP TO 48 MONTHS AFTER COMPLETION OF A PRIMARY SERIES OF BIVALENT rLP2086, AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT rLP2086.

KLINICKÉ HODNOCENÍ FÁZE 3 POSUZUJÍCÍ PŘETRVÁVÁNÍ ODPOVĚDI hSBA PO DOBU AŽ 48 MĚSÍCŮ OD DOKONČENÍ PRIMÁRNÍHO CYKLU OČKOVÁNÍ BIVALENTNÍ VAKCÍNOU rLP2086 A BEZPEČNOST, TOLERANCI A IMUNOGENITU POSILOVACÍ DÁVKY BIVALENTNÍ VAKCÍNY rLP2086

A.3.1

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

A study to find out how long a person continues to have antibodies against Meningococcal B disease following vaccination

A.4.1

Sponsor's protocol code number

B1971033

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	Pfizer Inc., 235 East 42nd Street, New York, NY 10017
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	+1 800 7181021
B.5.5	Fax number	+1 303 7391119
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	N meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 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.3.10	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Meningococcal type B Bacterial Meningitis

E.1.1.1

Medical condition in easily understood language

Meningococcal type B Bacterial 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	20.1
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

Stage 1:
To describe the immunogenicity of bivalent rLP2086 as determined by hSBA titers to 4 primary test strains at approximately 6, 12, 18, 24, 36, and 48 months after the last dose (second or third dose) of bivalent rLP2086 or saline in the primary study (ie, a previously conducted Pfizer study using the final formulation and dose of bivalent rLP2086).

Booster Stage:
To describe the immune response as measured by hSBA titers to 4 primary test strains 1 month after the last dose (second or third dose) of bivalent rLP2086 in the primary study, before the booster vaccination, and 1 month, 12 months, and 26 months after a single booster dose of bivalent rLP2086.

Primary Safety Objective (Booster Stage):
Please refer to the Protocol Section 2.1.2.

Exploratory Objectives for Stage 1 and Booster Stage):
Please refer to the Protocol Section 2.1.3

E.2.2

Secondary objectives of the trial

There are no Secondary Objectives for this Study.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet the following Stage 1 inclusion criteria to be eligible for enrollment into Stage 1 of the study. The criteria listed for the Booster Stage are required, in addition to Stage 1 inclusion criteria, in order to be eligible to continue into the booster stage of the
study.

Stage 1:
1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.

2. Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.

3. Subjects who completed a primary study and received all the scheduled injections within the originally planned schedule, either with bivalent rLP2086 (either 2 or 3 doses) or with investigational product in cases where subject vaccine assignment is blinded at the time of consent for Study B1971033.

4. Subjects who completed the blood draw following the last vaccination and subjects who completed the 6-month follow-up telephone call in the primary study.

Booster Stage Visits 7 to 10:
1. Evidence of a personally signed and dated ICD indicating that the subject or subject’s parent(s)/legal guardian has been informed of all pertinent aspects for Visits 7 to 10 of the booster stage of the study.

2. Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.

3. Subject is confirmed as having received bivalent rLP2086 in the primary vaccination study.

4. Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw.

5. Subject is available for the entire period of the booster stage and the subject or subject’s parent(s)/legal guardian can be reached by telephone.

6. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of
contraception through Visit 10 of the booster stage. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.

8. Negative urine pregnancy test for all female subjects on the day of
the booster dose.

Booster Stage Visit 11:
1. For subject participating in Visit 11, evidence of a personally signed and dated ICD indicating that the subject or subject's parent(s)/legal guardian has been informed of all pertinent aspects of Visit 11.
2.Subject continue to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.
3.Subject must have received 2 or 3 doses of bivalent rLP2086 in the primary study on a 0-,2-, and 6-months or a 0- and 6-month schedule.
4. Subject must have completed booster vaccination at Visit 7.

E.4

Principal exclusion criteria

The exclusion criteria listed for Stage 1 must not met for enrollment in Stage 1 of the study. In order to be eligible for enrollment into the booster stage of the study, the exclusion criteria listed for the booster stage must not to be met, in addition to not meeting any of the
exclusion criteria for Stage 1.

Criteria are listed for Stage 1 and the booster stage of the study.

Stage 1:
1. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.

2. With the exception of the primary study of bivalent rLP2086, participation in other studies within the 1-month (30-day) period before study Visit 1 and/or during study participation. Participation in purely observational studies is permitted.

3. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation 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.

4. History of culture-proven disease caused by N meningitidis or Neisseria gonorrhoeae.

5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate blood draw.

6. Receipt of any blood products, including gamma globulin, in the period from 6 months before any study visit.

7. Vaccination with any licensed or experimental meningococcal serogroup B vaccine since being enrolled in the primary Pfizer-sponsored MnB study (other than study vaccines permitted in the primary study).

8. Subjects who were not compliant with primary study eligibility criteria while enrolled in the primary study.

Booster Stage:
1. Subjects who are scheduled to receive 1 or more doses of a human papillomavirus (HPV) vaccine as part of a 3-dose series during the 28 days after the booster vaccination.

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

3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.

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

5. A known or suspected defect 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, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the
United States with terminal complement deficiency are excluded from participation in this study. Please refer to the study reference manual (SRM) for additional details.

6. Significant neurological disorder or history of seizure (excluding simple febrile seizure).

7. Current chronic use of systemic antibiotics.

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

9. Received any investigational vaccines, drugs, or devices within 28 days before administration of the booster vaccination.

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

11. Pregnant female subjects, breastfeeding female subjects, male subjects with partners who are currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol through Visit 10 of the study.

E.5 End points

E.5.1

Primary end point(s)

The 4 primary test strains for hSBA testing are PMB80 (A22 variant), PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44). The lower limit of quantitation (LLOQ) for PMB80 (A22) is an hSBA titer equal to 1:16. The LLOQ for the other 3 primary test strains is an hSBA titer equal to 1:8.

hSBA assays using the 4 primary test strains will be conducted using sera obtained at Visits 1 to 6 from all subjects entered into stage 1, including subjects who did not receive bivalent rLP2086 in the primary study (B1971015 Group 2).

Stage 1:
Proportion of subjects with hSBA titers ≥ LLOQ for each of the 4 primary strains at each blood draw visit in Stage 1 (Visits 1-6).

Booster Stage
- Proportions of subjects with hSBA titers ≥ LLOQ for each of the 4 primary strains at 1 month following the last vaccination received in the primary study, before the booster vaccination (Visit 6), and 1 month, 12 months, and 26 months (Visit 8, 10, and 11) following booster vaccination.

Safety Endpoints (Booster Stage):
- Percentages of subjects reporting local reactions via the electronic diary (e-diary) by type (pain at the injection site, redness, and swelling) and by severity after a booster vaccination of bivalent rLP2086.

- Percentages of subjects reporting systemic events via the e-diary by type (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain) and by severity after a booster vaccination of bivalent rLP2086.

- Percentage of subjects reporting the use of antipyretic medication via the e-diary after a booster vaccination of bivalent rLP2086.

- Percentages of subjects with at least 1 AE occurring during the following time periods:
- From Visit 7 to Visit 8

- Percentages of subjects with at least 1 SAE during the following periods:
- From Visit 7 to Visit 8
- From Visit 8 to Visit 9
- From Visit 7 to Visit 9

- Percentages of subjects with at least 1 NDCMC occurring during the following time periods:
- From the 6-month safety telephone call in the primary study to Visit 6 (Stage 1)
- From Visit 7 to Visit 8
- From Visit 8 to Visit 10
- From Visit 7 to Visit 10 -From Visit 8 to Visit 11 (only subjects proceeding to Visit 11) -From Visit 7 to Visit 11 (only subjects proceeding to Visit 11)

- Percentages of subjects with at least 1 medically attended event occurring during the following time periods:
- From Visit 7 to Visit 8
- From Visit 8 to Visit 9
- From Visit 7 to Visit 9

- Percentage of subjects reporting at least 1 immediate AE after receiving the booster dose of bivalent rLP2086.

- Number of days subjects miss school or work because of AEs from Visit 7 through Visit 9.

For the Exploratory Endpoints for Stage 1 and Booster Stage:
Please refer to Protocol Section 2.2.4.

E.5.1.1

Timepoint(s) of evaluation of this end point

Blood draws for serology assessment at 6, 12, 18, 24, 36, and 48 months after last dose of bivalent rLP2086, or after last injection of
investigational product in primary study

E.5.2

Secondary end point(s)

Not Applicable in this case.

E.5.2.1

Timepoint(s) of evaluation of this end point

Not Applicable in this case.

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

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

Duration of immunity.

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

E.8.1.1

Randomised

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

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

E.8.4

The trial involves multiple sites in the Member State concerned

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

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

As per Protocol.

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:

1128

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:

204

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

924

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-12.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

800

F.4.2.2

In the whole clinical trial

1200

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)

None as not applicable in this case.

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

2012-04-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-01-05

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