Phase 3, Adolescent Large Scale Safety Study
- Conditions
- Bacterial MeningitisMedDRA version: 14.1Level: LLTClassification code 10004049Term: Bacterial meningitisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2009-015198-11-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 7500
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. 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 indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3.Male or female subjects aged ?11 and <26 years at 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.Parent/legal guardian and/or subject must be able and willing to complete all relevant study procedures during study participation.
7.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 female subjects of childbearing potential must practice an effective form of contraception during the study.
8.Negative urine pregnancy test for female subjects.
Are the trial subjects under 18? yes
Number of subjects for this age range: 4103
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3397
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects presenting with any of the following will not be included in the study:
1.Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
2.Subject is a direct descendant (e.g. child, grandchild or other family member) of study site personnel.
3.Previous vaccination with any meningococcal serogroup B vaccine.
4.Subjects who have received prior HAV vaccination.
5.Contraindication to vaccination with any HAV vaccine.
6.A previous anaphylactic reaction to any vaccine or vaccine related component.
7.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
8.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 or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may be included. Please refer to the SRM additional details.
9.History of culture proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
10.Significant neurological disorder or history of seizure (excluding simple febrile seizure).
11.Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
12.Current participation in another investigational study. Participation in purely observational studies is acceptable.
13.Received any investigational drugs or devices within 28 days before administration of the first study vaccination.
14.Any neuroinflammatory and autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
15.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.
16.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 Main Objective: To evaluate the safety profile of rLP2086 vaccine, as measured by adverse events (AEs), during the 6 month vaccination period and 6 month postdose 3 follow up.;Secondary Objective: To describe the immune response induced by the rLP2086 vaccine as measured by serum bactericidal assays using human complement (hSBAs) performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after study vaccinations 2 and 3 in a subset of 255 randomly assigned subjects (170 recipients of 120 ?g rLP2086 vaccine and 85 control subjects).;Primary end point(s): The primary endpoints will be the safety related variables, as measured by adverse events (AEs), and serious adverse events (SAEs).;Timepoint(s) of evaluation of this end point: 14 months after last subject last visit.
- Secondary Outcome Measures
Name Time Method