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: | Completed |
---|---|
Conditions: | Vaccines |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 10 - 12 |
Updated: | 12/22/2018 |
Start Date: | September 28, 2011 |
End Date: | May 8, 2014 |
A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Mcv4, Tdap Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged > = 10 To <13 Years
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.
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.
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.
We found this trial at
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Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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University of South Florida The University of South Florida is a high-impact, global research university...
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Chandler, Arizona 85224
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1011 East Jefferson Street
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Charlottesville, Virginia 22902
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Cincinnati, Ohio 45229
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El Reno, Oklahoma 73036
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Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Kaiser Permanente - Sacramento At the Kaiser Permanente South Sacramento Medical Center, you and your...
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