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

Phase 1

Conditions: Healthy volunteers (prevention of bacterial meningitis).
MedDRA version: 14.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2009-014493-18-ES

Lead Sponsor: PFIZER S.L.U.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1712

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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