A 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 µg, 120 µg, and 200 µg in Healthy Adolescents Aged 11 to 18 Years

Pfizer Inc0 sites715 target enrollmentFebruary 9, 2009

Overview

No summary available.

Registry

who.int

Start Date

February 9, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male or female subjects between the ages of \=11 and \=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.
•1\. Healthy male or female subjects as determined by medical history and physical examination.
•2\. 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

•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.