Ensayo de fase 2, aleatorizado, en simple ciego y controlado con placebo, de la seguridad, la capacidad inmunógena y la tolerabilidad de la vacuna rLP2086 frente al meningococo de serogrupo B (MnB) a dosis de 60 microgramos, 120 microgramos y 200 microgramos en adolescentes sanos de 11 a 18 añosA Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60 micrograms, 120 micrograms, and 200 micrograms in Healthy Adolescents Aged 11 to 18 Years

Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 715 人开始时间: 2009年3月27日最近更新: 2014年6月30日

适应症

试验速览

暂无简介。

•1. Male or female subjects between the ages of equal or greater to 11 and less or equal to 18 years at the time of enrollment.
•2. Healthy male or female subjects as determined by medical history and physical examination.
•3. Negative urine pregnancy test for all female subjects.
•4. All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of hormonal and/or nonhormonal contraception during the 6-month vaccination period and for 30 days after the final vaccination or early discontinuation of the study. A subject is biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
•5. Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Pregnant or breastfeeding women.
•2. Receipt of any vaccination with a serogroup B meningococcal vaccine at any time prior to the administration of the first dose of test article.
•3. History of any invasive meningococcal disease.
•4. A previous anaphylactic or severe vaccine-associated adverse reaction.
•5. A known hypersensitivity to any study vaccine components.
•6. Any clinically significant chronic disease.
•7. A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
•8. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular (IM) injection.
•9. Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
•10. Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
•11. Any major illness/condition that, in the investigators judgment, will substantially increase the risk associated with the subjects participation in and completion of, the study, or could preclude the evaluation of the subjects response.
•12. Subject is a direct descendant (child or grandchild) of the study site personnel.

发起方

Wyeth Research Division of Wyeth Pharmaceuticals Inc.