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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

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
Radiant Research, Inc.
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines, Meningococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-12 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01461980
Pfizer
Completed
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

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[email protected]

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