Clareo Health | A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
10–12
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study.
Parent /legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
Male or female subject aged greater than or equal to 10 and \<13 years at the time of enrollment.
Available for the entire study period and can be reached by telephone.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Has received full series (5-dose series is preferred, 4-dose catch up series is allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per country specific recommendations applicable at the time of receipt.
Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study.
You may not be if
Previous vaccination with any meningococcal serogroup B vaccine.
Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the first study vaccination.
Previous vaccination with any MCV4 vaccine.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with MCV4 and/or Tdap vaccine.
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.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
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. Subjects with terminal complement deficiency may not be included.
History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
Current chronic use of systemic antibiotics.
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
