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: 24 June 2013
• Main ID: EUCTR2009-014493-18-FI
• Date of registration: 02/08/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc 235 East 42nd Street, New York, NY10017
• 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 Bivalent rLP2086 Vaccine When Administered in Either 2- or 3-Dose Regimens in Healthy Subjects Aged =11 to <19 Years
• Date of first enrolment: 01/10/2010
• 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

Countries of recruitment

Czech Republic, Denmark, Finland, Germany, Poland, Spain, 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:
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 (ICD) 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
Product Code: Not Applicable
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-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

Primary end point(s): The primary endpoint for the first co-primary objectives are the proportion of subjects achieving hSBA titer = lower limit of quantitation (LLOQ), for each of the 4 primary strains, measured 1 month after the third vaccination with bivalent rLP2086 vaccine (as measured at visit 6) among group 1 subjects.

The primary endpoint for the second co-primary objectives are the
proportion of subjects achieving hSBA titer = LLOQ, for each of the 4 primary strains, measured 1 month after the third vaccination with bivalent rLP2086 vaccine (visit 6) among group 2 subjects.).

Main Objective: Co-Primary Objectives:

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 bivalent rLP2086 vaccine among group 1 subjects.

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 bivalent rLP2086 vaccine among group 2 subjects.

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 bivalent rLP2086 vaccine among group 3 subjects.

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).

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

Secondary Outcome(s)

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

Secondary end point(s): The endpoint for the first of the secondary objectives is the
proportion of subjects achieving hSBA titer = LLOQ, for each of the 4 primary strains, measured 1 month after the second vaccination with bivalent rLP2086 vaccine among group 3 subjects.

The testing strategy for the above hypothesis testing endpoints is described in Section 9.5.
Additional secondary endpoints for descriptive purposes include the following:
1.hSBA geometric mean titers (GMT) for each of the 4 primary strains at each blood sampling time point;
2.Proportion of subjects with hSBA titer = LLOQ, for each of the 4 primary strains, at each blood sampling time point;
3. Proportions of subjects with hSBA titers =1:4, =1:8, =1:16, =1:32, =1:64, = 1:128 at each blood sampling time point.

Secondary ID(s)

B1971012(6108A1-2003-EU)

2009-014493-18-SE

Source(s) of Monetary Support

Pfizer Inc