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
Status and phase
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Study type
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Identifiers
Details and patient eligibility
About
This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.
Enrollment
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Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Trial design
2,648 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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