Test the safety and immunogenicity of Bexsero used as a vaccine for Neisseria meningitidis MedDRA version: 18.0 Level: PT Classification code 10027249 Term: Meningitis meningococcal System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Bexsero suspension for injection in pre-filled syringe Meningococcal Group B Vaccine.
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Recombinant N
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Immunogenicity Objective • To describe the immune response, relative to baseline status, following receipt of Bexsero as measured by hSBA performed with a panel of MnB test strains assessed 1 month after the second vaccination with Bexsero vaccine. Primary Safety Objective • To describe local reactions and systemic events following receipt of Bexsero vaccine.;Secondary Objective: Not applicable;Primary end point(s): Primary Immunogenicity Endpoint • Proportion of subjects achieving at least a 4-fold increase in hSBA titer from baseline to 1 month after the second vaccination with Bexsero vaccine for each strain included in the panel of MnB test strains. Primary Safety Endpoints • Percentage of subjects reporting local reactions (pain, redness, and swelling). • Percentage of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at any injection site, and joint pain). • Percentage of subjects reporting the use of antipyretic medication after each vaccination visit.;Timepoint(s) of evaluation of this end point: 1 month after the second vaccination with Bexsero vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: 1 month after the second vaccination with Bexsero vaccine. | — |
Countries
Denmark
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed