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

• Register: EUCTR
• Last refreshed on: 25 January 2016
• Main ID: EUCTR2011-005697-31-DE
• Date of registration: 16/03/2012
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: A study to find out how long a person continues to have antibodies against Meningococcal B disease following vaccination
• 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: 16/05/2012
• Target sample size: 1200
• 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

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 (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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1128
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
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 directly involved in the conduct of the trial 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 trial.

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. 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 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.


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

Health Condition(s) or Problem(s) studied

Meningococcal type B Bacterial Meningitis
MedDRA version: 17.1 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 last dose of bivalent rLP2086, or after last injection of
investigational product in primary study

Main Objective: To describe the immunogenicity of bivalent rLP2086 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 third dose) of bivalent rLP2086 in the primary study (ie, a previously conducted Pfizer study using the final formulation and dose of bivalent rLP2086).

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

Primary end point(s): Proportion of subjects with hSBA titers = lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit.

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)

B1971033

2011-005697-31-CZ

Source(s) of Monetary Support

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