A study to measure pretection (antibody response) and safety against representative strains causing a high proportion of disease (Meningococcal Group B) in healthy subject aged between 12 and <19 years.
- Conditions
- Test the safety and immunogenicity of Bexsero used as a vaccine for Neisseria meningitidisMedDRA version: 18.0Level: PTClassification code 10027249Term: Meningitis meningococcalSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-003822-42-DK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Subject eligibility should be reviewed and documented by an appropriate 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/assent
document indicating that the subject (and a legally acceptable
representative/parent(s)/legal guardian, if applicable) has been
informed of all pertinent aspects of the study.
2. Subjects (and legally acceptable representative/parent(s)/legal
guardian, if applicable) who are willing and able to comply with
scheduled visits, treatment plan, laboratory tests, and other study
procedures.
3. Male or female subjects aged 12 years to <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. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study (through the persistence blood draw visit at Month 7).
7.Negative urine pregnancy test for all female subjects who are
biologically capable of having children.
Are the trial subjects under 18? yes
Number of subjects for this age range: 102
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
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. Previous vaccination with any meningococcal serogroup B vaccine.
2. Subjects who have received any non-live vaccine (or intramuscular/sublingual allergen immunotherapy) within the previous 14 days or live vaccine within the previous 28 days of study vaccination.
3. Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
4. A previous anaphylactic reaction to any vaccine or vaccine-related component, including kanamycin and latex.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6. 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. Additional details will be
provided in the study reference manual (SRM).
7. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
8. Significant neurological disorder or history of seizure (excluding
simple febrile seizure).
9. Receipt of any blood products, including immunoglobulin, within 6
months before the first study vaccination.
10. Current chronic use of systemic antibiotics.
11. Participation in other studies involving investigational vaccines,
drugs, or devices within 28 days before the current study begins and during study participation. Participation in purely observational studies is acceptable.
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. Pregnant female subjects, breastfeeding female subjects, male subjects with partners currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the
duration of the study (through the persistence blood draw visit at Month 7).
14. 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.
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