Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine
Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60µg, 120µg, and 200µg in Healthy Adolescents Aged 11 to 18 Years
Investigator: Associate Professor Peter Richmond
The purpose of this study is to collect information about how safe the Meningococcal B (rLP2086) vaccine is in healthy adolescents aged 11-18 years of age.
This Meningococcal B vaccine is new but has been used in
previous studies in adults and children. In this study, some of the
ingredients in the vaccine have changed so that the vaccine can be
made more easily.
This is the second time the vaccine will be administered to adolescents and this study will evaluate the immune response of adolescents to the vaccine and examine the safety of the vaccine.
Stage 1: The aim of this study was to evaluate the safety, tolerability and immune response of the investigational Meningococcal B vaccine in adolescents aged 11 - 18 years. In order to evaluate the Meningococcal B vaccine some adolescents/young adults will be given a placebo vaccine.
The Meningococcal B vaccine was evaluated at three dose levels. The Vaccine Trials Group enrolled 77 participants in stage 1.
Stage 2: Participation in Stage 2 will last up to 3 ½ years. Subjects who received specific dose levels and placebo were invited to participate in stage 2. Stage 2 aims to continue to evaluate the vaccine's ability to produce long term protection to Meningococcus B disease. Vaccine Trials Group enrolled 33 participants in stage 2.
Funder of project: Wyeth Australia Pty Ltd / Pfizer Australia and New Zealand