An Open-Label, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Adolescents Who Previously Received MenACWY-CRM Conjugate Vaccine or Menactra

ovartis Vaccines and Diagnostics Inc.0 个研究点目标入组 825 人开始时间: 2014年11月25日最近更新: 2014年12月1日

适应症

试验速览

暂无简介。

•Healthy naive male and female individuals were recruited from the local communities and
•were age-matched with those who previously participated in V59P13 study.
•Healthy follow-on male and female subjects who previously completed the V59P13 study
•protocol and were 11 through 18 years of age inclusive at the time of the enrollment into
•the V59P13 study were recruited into this extension study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 825
•F.1.2 Adults (18-64 years) no
•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

•Naive individuals not eligible to be enrolled in the study were those:
•? Who were unwilling or unable to give written informed assent or consent to participate in the study;
•? Who had a previous or suspected disease caused by N meningitidis;
•? Who had household contact with and/or intimate exposure to an individual with
•culture-proven N meningitidis infection within 60 days prior to enrollment;
•? Who had previously been immunized with a meningococcal vaccine or
•vaccine containing meningococcal antigen(s) (licensed or investigational)
•(Exception: Receipt of Outer Membrane Particle (OMP)-containing Hemophilus influenza B (Hib) vaccines was permitted);
•? Who had prior military service;
•? Who had received any investigational agents or vaccines within 90 days prior to
•enrollment or who expected to receive an investigational agent or vaccine prior to the
•completion of the study;
•? Who had received any licensed vaccines within one month prior to enrollment
•(Exception: Influenza vaccine may have been administered up to 15 days prior to
•enrollment);
•? Who had received a live viral vaccine within 60 days prior to enrollment;

发起方

ovartis Vaccines and Diagnostics Inc.