A clinical trial to determine if the investigational MnB vaccine works when 2 or 3 doses of the vaccine is given to adolescents.

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2009-014493-18-ES
• Date of registration: 25/06/2010
• Prospective Registration: Yes
• Primary sponsor: PFIZER S.L.U.
• Public title: A clinical trial to determine if the investigational MnB vaccine works when 2 or 3 doses of the vaccine is given to adolescents.
• Scientific title: A Phase 2, Randomized, Placebo-Controlled, Single-blind Trial to Assess the Safety, Tolerability, and Immunogenicity of rLP2086 Vaccine When Administered in Either 2- or 3-Dose Regimens in Healthy Subjects Aged more or equal 11 to <19 Years
• Date of first enrolment: 23/08/2010
• Target sample size: 1714
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014493-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: yes; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 5
• 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, Spain, Sweden

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
Subject eligibility should be reviewed and documented by an appropriately qualified member
of the investigator’s study team before subjects are included in the study.
1. Evidence of a personally signed and dated informed consent document indicating that
the parent/legally acceptable representative and/or subject has been informed of all
pertinent aspects of the study.
2. Parent/legally acceptable representative and/or subjects who are willing and able to
comply with scheduled visits, treatment plan, laboratory tests, and other study
procedures.
3. Male or female subject aged =11 and <19 years at the time of enrollment.
4. Available for the entire study period and can be reached by telephone.
5. Healthy subject as determined by medical history, physical examination, and
judgment of the investigator.
6. All male and female subjects must agree to practice a form of effective contraception,
such as barrier contraception (ie, condom plus spermicide, a female condom,
diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral
contraceptives or sexual abstinence prior to entering into the study, for the duration of
the vaccination period and for 28 days after the last study vaccination. For
Germany: The phrase sexual abstinence is not applicable, with the understanding that
all male and all female subjects of childbearing potential must practice an effective
form of contraception during the study.
7. Negative urine pregnancy test for female subjects.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1524
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
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. Previous vaccination with any meningococcal serogroup B vaccine.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component
3. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
4. A known or suspected disease of the immune system or those receiving
immunosuppressive therapy.
5. History of culture-proven disease caused by Neisseria meningitidis or Neisseria
gonorrhoeae.
6. Significant neurological disorder or history of seizure (excluding simple febrile
seizure).
7. Receipt of any blood products, including immunoglobulin within 6 months before the
first study vaccination.
8. Current chronic use of systemic antibiotics.
9. Participation in other studies during study participation. Participation in purely
observational studies is acceptable.
10. Received any investigational drugs, vaccines or devices within 28 days before
administration of the first study vaccination.
11. Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
12. 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.
13. Subjects who are investigational site staff members or subjects who are Pfizer
employees directly involved in the conduct of the trial.
14. Subject is a direct descendant (e.g., child, grandchild or other family member) of study site or Pfizer personnel.
15. Subject is pregnant or breastfeeding.


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

Health Condition(s) or Problem(s) studied

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

Healthy volunteers (prevention of bacterial meningitis).
MedDRA version: 14.1 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Product Name: MnB rLP2086
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: MnB rLP2086 subfamilia A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 120-
INN or Proposed INN: MnB rLP2086 subfamilia B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

Main Objective: - To assess the immune response as measured by serum bactericidal assay performed with
MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the
third vaccination with rLP2086 vaccine, administered according to a 0- 1- and 6-month
schedule (group 1).
- To assess the immune response as measured by serum bactericidal assay performed with
MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the
third vaccination with rLP2086 vaccine, administered according to a 0- 2- and 6-month
schedule (group 2).

Timepoint(s) of evaluation of this end point: One month after the third dose of rLP2086 (Groups 1 and 2).

Primary end point(s): The primary endpoint for the co-primary objectives are the proportion of sujects achieving an rLP2086-specific SBA titer > or = to 1:4, for each of the 4 primary strains, measured 1 month after the third vaccination with rLP2086 vaccine (or measured at month 7) (in groups 1 an 2, respectively)

Secondary Objective: - To assess the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the second vaccination with rLP2086 vaccine, administered according to a 0-, , and 6-month schedule (group 3).
- To describe the immune response as measured by serum bactericidal assay performed
with MnB strains expressing LP2086 subfamily A and B proteins, throughout the study
(all groups).

Secondary Outcome(s)

Secondary end point(s): The endpoint for the first of the secondary objectives is the proportion of subjects achieving an rLP2086-specific SBA titer =1:4 for each of the 4 primary strains, measured 1 month after the second vaccination with rLP2086 vaccine (or measured at month 7) in group 3.
The testing strategy for the above hypothesis testing endpoints is described in Section 11.5.
Additional secondary endpoints for descriptive purposes include the following:
1.SBA titers for each of the 4 primary strains at each blood sampling time point;
2.Proportion of subjects achieving an rLP2086-specific SBA titer =1:4, for each of the 4 primary strains, at each blood sampling time point;
3.Proportion of subjects achieving a 4-fold rise on rLP2086-specific SBA titer from baseline (day 1) to each blood sampling time point;
4.Proportions of subjects achieving rLP2086-specific SBA titers =1:8 at each blood sampling time point;
5.Proportions of subjects achieving rLP2086-specific SBA titers =1:16 at each blood sampling time point;
6.Proportions of subjects achieving rLP2086-specific SBA titers =1:32 at each blood sampling time point;
7.Proportions of subjects achieving rLP2086-specific SBA titers =1:64 at each blood sampling time point;
8.Proportions of subjects achieving rLP2086-specific SBA titers =1:128 at each blood sampling time point;
9.Fold-rise for the following:
•Fold-rise from baseline to month 7;
•Fold-rise from baseline to month 3;
•Fold-rise from baseline to month 2.

Timepoint(s) of evaluation of this end point: One month after the second dose of rLP2086 (group 3) and at other time points detailed in E.5.2.

Secondary ID(s)

2009-014493-18-SE

B1971012(6108A1-2003-EU)

Source(s) of Monetary Support

Pfizer Inc.

Ethics review

Status: Approved
Approval date: 16/08/2010
Contact:

Results

• Results available: Yes
• Date Posted: 01/08/2015
• Date Completed: 18/09/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-014493-18/results