A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When… (NCT01323270) | Clinical Trial Compass
CompletedPhase 2
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.
Finland753 participantsStarted 2011-03-18
Plain-language summary
This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how it is tolerated when given together with Repevax. The study will be done in healthy adolescents.
Who can participate
Age range11 Years – 18 Years
SexALL
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Inclusion Criteria:
* 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 \<19 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 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 pregn…
What they're measuring
1
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen
Timeframe: 1 month after Vaccination 1
2
Percentage of Participants With at Least One Adverse Event (AE)
Timeframe: Vaccination 1 up to 1 month after Vaccination 3