A Phase III, observer-blind, randomized, active controlled study

PATH0 个研究点目标入组 6,000 人开始时间: 2010年2月5日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1-Age 1 to 29 years of age (both included)
•2-Written informed consent obtained from the subject (for subjects ¿18 years of age) / parents or guardian (for subjects < 18 years of age)
•3-Written informed assent obtained from the subject (for subjects ¿ 10 years and < 18 years of age as appropriate within the site participating community)
•4-Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator
•5-Subject / parents or guardian capable and willing to come / bring their child or to receive home visits for them / their child for all follow-up visits
•6-Residence in the study area
•7-Fully vaccinated according to the local EPI schedule (for subjects 1 to 2 years of age)

•1-History of allergic disease or known hypersensitivity to any component of the two study vaccines and/or following administration of vaccines included in the local program of immunization
•2-Administration of any other vaccine within 30 days prior to administration of study vaccines or planned vaccination during the first 28 days after the study vaccination
•3-Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines
•4-Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever (axillary temperature ¿ 38°C)) is a temporary exclusion.
•5-Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study
•6-Non residence in the study area or intent to move out within 3 months
•7-Pregnancy or lactation. A negative pregnancy test will be required before vaccination for all women of childbearing potential, i.e. postmenarcheal and /or married women
•8-Previous inclusion of five family members in the study, i.e. subjects belonging to the same family (biological father, mother, child, and brothers and sisters) may be included up to a maximum of five members from the same family

发起方