Effectiveness of an eleven-valent pneumococcal (type 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) conjugate vaccine against pneumonia in Philippine children: A double-blind, placebo-controlled, randomised, multicentre, effectiveness study

ARIVAC Consortium (Finland)0 个研究点目标入组 12,190 人开始时间: 2006年1月25日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•For the effectiveness study and the nested immunogenicity study:
•1. Any child who comes for routine vaccination to a barangay health station in the 48 barangays in the six municipalities of Bohol, the Philippines (i.e. Baclayon, Balilihan, Cortes, Dauis, Panglao and Tagbilaran)
•2. Considered to be in good health on the basis of medical history and observation taken at the barangay health station
•3. At least 6 weeks of age and not older than 6 months of age
•4. Having at least one parent or other legal representative giving their informed consent attested by signature
•For the effectiveness study:
•Is a resident of any of the barangays within the catchment of the 45 barangay health stations of the six municipalities for at least the past 3 months with his/her family, or intends to stay permanently
•For the nested immunogenicity, safety and carriage study:
•Is a resident of any of the barangays within the catchment of the three chosen barangay health stations (i.e. Dampas-Tagbilaran, Danao and Main Health Center-Panglao) for at least the past 3 months with his/her family, or intends to stay permanently

•For the effectiveness study and the nested immunogenicity study:
•Any child who:
•1. Has received the first dose of diphtheria, tetanus, pertussis (DTP) vaccine
•2. Has acute febrile illness (rectal temperature >/= 38.5°C) at the time of inclusion
•3. Is suspected to have a neurological disease (a contraindication to the DTP vaccine)
•4. Has history of hospitalization for and/or treatment for immune suppression
•5. Is enrolled or scheduled to be enrolled in another clinical trial

发起方

ARIVAC Consortium (Finland)