ong-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4- to 5 year old Children Previously Vaccinated with a 2-dose or 3-dose Infants series and Toddler dose with VAXELIS® or INFANRIX® hexa

MCM Vaccine B.V.0 个研究点目标入组 760 人开始时间: 2016年2月18日最近更新: 2017年5月22日

适应症

试验速览

暂无简介。

•An individual must fulfill all of the following criteria in order to be eligible for study enrolment:
•1. Healthy child of either gender, who has received a complete 3-dose primary series or a complete 2 dose primary series followed by a toddler dose with VAXELIS® or INFANRIX® hexa as part of the V419-007 or V419-008 study respectively;
•2. Informed consent signed by the subject's parent(s) or legal representative.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 760
•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

•Subjects meeting at least one of the following criteria will be ineligible for study enrolment:
•1. Subject who has received any dose of HB containing vaccine at any time other than study vaccine in V419-007 or V419-008 study;
•2. Subject with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study;
•3. Subject who has received any dose of pertussis containing vaccine after completion of the V419-008 study;
•4. Subject with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study;
•5. Participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure*;
•6. Subject who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion*;
•7. Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008 studies;
•8. Subject with suspected or known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopietic and lymphatic systems since completion of V419-007 or V419-008 studies.

发起方