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A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.

Last updated on February 21, 2019

FOR MORE INFORMATION
Study Location
Espoo Vaccine Research Clinic
Espoo, , 02100 Finland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Vaccine, rLP2086, Repevax, N Meningitidis Serogroup B, Meningitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
11-18 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 indicating that
the parent/legally acceptable representative and/or subject has been informed of all
pertinent aspects of the study.

- Parent/legally acceptable representative and/or subjects who are willing and able to
comply with scheduled visits, laboratory tests, and other study procedures.

- Male or female subject aged ≥11 and

- 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 of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and
oral poliomyelitis virus (OPV)/IPV vaccines per country-specific recommendations
applicable at the time of receipt.

- All male and female subjects must agree to practice a form of effective contraception,
such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm,
cervical cap or intrauterine device), implants, injectables, combined oral
contraceptives or sexual abstinence prior to entering into the study, for the duration
of the vaccination period and for 28 days after the last study vaccination. For
Germany: The phrase sexual abstinence is not applicable, with the understanding that
all male and all female subjects of childbearing potential must practice an effective
form of contraception during the study.

- Negative urine pregnancy test for female subjects.

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, pertussis, or poliomyelitis virus vaccine
within 5 years of the first study vaccination.

- A previous anaphylactic reaction to any vaccine or vaccine-related component.

- Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis
virus vaccine.

- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

- A known or suspected disease of the immune system or those receiving immunosuppressive
therapy.

- History of culture-proven disease caused by Neisseria meningitidis or Neisseria
gonorrhoeae.

- 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.

- Participation in other studies during study participation. Participation in purely
observational studies is acceptable.

- Received any investigational drugs, vaccines or devices within 28 days before
administration of the first study vaccination.

- Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

- 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.

- Subjects who are investigational site staff members or subjects who are Pfizer
employees directly involved in the conduct of the trial.

- Subject is a direct descendant (eg, child, grandchild or other family member) of study
site or Pfizer personnel.

- Subject is pregnant or breastfeeding.

NCT01323270
Pfizer
Completed
A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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