A DURATION OF IMMUNITY STUDY, TO ASSESS PERSISTENCE OF hSBA RESPONSE FOR UP TO 48 MONTHS AFTER COMPLETION OF VACCINATION WITH BIVALENT rLP2086 VACCINE

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2011-005697-31-PL
• Date of registration: 25/09/2012
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: A DURATION OF IMMUNITY STUDY, TO ASSESS PERSISTENCE OF hSBA RESPONSE FOR UP TO 48 MONTHS AFTER COMPLETION OF VACCINATION WITH BIVALENT rLP2086 VACCINE
• Scientific title: A DURATION OF IMMUNITY STUDY, TO ASSESS PERSISTENCE OF hSBA RESPONSE FOR UP TO 48 MONTHS AFTER COMPLETION OF VACCINATION WITH BIVALENT rLP2086 VACCINE
• Date of first enrolment: 23/10/2012
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005697-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic, Denmark, Finland, Germany, Poland, Sweden

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

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 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. Completed primary Pfizer Sponsored MnB study meaning subjects who completed their originally intended number of scheduled vaccinations of rLP2086 vaccine,
subjects who completed the blood draw following the last vaccination and subjects who completed the 6 months follow-up telephone call in the ‘primary’ study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 720
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects presenting with any of the following will not be included in the study:
1. Subjects who are investigational site staff members or or subjects who are Pfizer employees directly involved in the conduct of the trial.
2. With the exception of the primary rLP2086 vaccine study, 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. Other 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 Neisseria 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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Meningococcal type B Bacterial Meningitis
MedDRA version: 15.0 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Product Name: N meningitidis Serogroup B Bivalent Recombinant Lipoprotein [rLP2086; subfamilyA&B; E coli] Vaccine
Product Code: MnB rLP2086 (PF-05212366)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: MnB rLP2086 Subfamily A
CAS Number: N/a
Current Sponsor code: N/a
Other descriptive name: N/a
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 120-
INN or Proposed INN: MnB rLP2086 Subfamily B
CAS Number: N/a
Current Sponsor code: N/a
Other descriptive name: N/a
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Blood draws for serology assessment at 6, 12, 18, 24, 36, and 48 months after the last dose (second or the third dose) of vaccine in the ‘primary’ study (defined as phase 2 and 3 B197 studies).

Main Objective: To describe the immunogenicity of rLP2086 vaccine as determined by hSBA-titers to primary test strains at approximately 6, 12, 18, 24, 36, and 48 months after the last dose (second or the third dose) of vaccine in the ‘primary’ study (a previously conducted Pfizer study using the final formulation and dose of rLP2086 vaccine).

Exploratory Objective:
To describe the immunogenicity of rLP2086 vaccine as determined by hSBA-titers to secondary test strains at approximately 6, 12 , 18, 24, 36, and 48 months after the last dose (2- or 3-dose regimen) of vaccine in the ‘primary’ study.

Primary end point(s): hSBA will be performed for the 4 primary test strains. hSBAs on additional secondary test strains may be performed.
• Proportion of subjects with hSBA titers = lower limit of quantitation (LLOQ), at each blood draw visit
• Proportion of subjects with hSBA titers =1:4, =1:8, =1:16 , =1:32, =1:64,and =1:128
at each blood draw visit
• hSBA geometric mean titers (GMTs) at each blood draw visit

Secondary Objective: There are no Secondary Objectives for this Study.

Secondary Outcome(s)

Secondary end point(s): Not Applicable in this case.

Timepoint(s) of evaluation of this end point: Not Applicable in this case.

Secondary ID(s)

2011-005697-31-CZ

B1971033

Source(s) of Monetary Support

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

Ethics review

Status: Approved
Approval date: 13/09/2012
Contact:

Results

• Results available: Yes
• Date Posted: 21/07/2018
• Date Completed: 05/01/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005697-31/results