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

• Register: EUCTR
• Last refreshed on: 7 May 2018
• Main ID: EUCTR2011-005697-31-FI
• Date of registration: 10/07/2012
• 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 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.
• Date of first enrolment: 15/08/2012
• 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
• 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 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 continues 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-month or a 0- and 6-month schedule.
4. Subject must have completed booster vaccination at Visit 7.
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:
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

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

Health Condition(s) or Problem(s) studied

Meningococcal type B Bacterial Meningitis
MedDRA version: 20.0 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 2086 Vaccine
Product Code: 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)

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 (Visits 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.

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: 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

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)

B1971033

2011-005697-31-CZ

Source(s) of Monetary Support

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