Trial of Simplified Pneumococcal Vaccination in Vietnam II: The Herd Immunity Approach

Murdoch Childrens Research Institute1 个研究点分布在 1 个国家目标入组 2,501 人开始时间: 2017年3月8日最近更新: 2024年11月27日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Murdoch Childrens Research Institute
入组人数: 2,501
试验地点: 1
主要终点: Carriage of Vaccine Type pneumococci

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a single-blind, open-label, randomised controlled trial with five groups. There are four different Pneumococcal Conjugate Vaccine (PCV) schedules to be evaluated.

详细描述

This is a single-blind, open-label, randomised controlled trial with five groups. There are four different PCV schedules to be evaluated: a 0+1 schedule of PCV10 at 12 months of age (Group V), a 0+1 schedule of PCV13 at 12 months of age (Group W), a 1+1 schedule of PCV10 at 2 and 12 months of age (Group X), and a 1+1 schedule of PCV13 at 2 and 12 months of age (Group Y); along with a control group that receives a dose of PCV10 at 24 months of age (Group Z). Additionally, all participants will receive four doses of Infanrix-hexa at 2, 3, 4 and 18 months of age.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Single (Outcomes Assessor)

盲法说明

This is a single-blind, open-label, randomised trial, with laboratory staff blinded to study group allocation as all the outcome measures that address the study objectives are laboratory based. Laboratory samples will be labelled with a unique trial identification number that does not identify the study group. Given the different timing of the vaccine schedules in the different study arms, the study nurses, vaccine administrators and participants will not be blinded to the study group allocation of each infant.

入排标准

年龄范围: 8 Weeks 至 10 Weeks（Child）
性别: All
接受健康志愿者: 是

入选标准

•Aged between 2 months and 2 months plus 2 weeks;
•No significant maternal or perinatal history;
•Born at or after 36 weeks gestation;
•Written and signed informed consent from parent/legal guardian;
•Lives within approximately 30 minutes of the commune health centre;
•Family anticipates living in the study area for the next 22 months

排除标准

•Known allergy to any component of the vaccine;
•Allergic reaction or anaphylactic reaction to any previous vaccine;
•Known immunodeficiency disorder;
•Known HIV-infected mother;
•Known thrombocytopenia or coagulation disorder;
•Administration or planned administration of any immunoglobulin or blood product since birth;
•Severe birth defect requiring ongoing medical care;
•Chronic or progressive disease;
•Seizure disorder;
•History of severe illness;
•Receipt of any 2 month vaccines through the Expanded Programme of Immunization (EPI) program;
•Family plans on giving the infant Quinvaxem (DTP-Hib-HBV).
•Additionally, enrolment will be deferred and infants asked to return to the health centre one week later for reassessment if they have at least one of the following deferral criteria:
•Axillary temperature ≥37.5°C or ≤35.5°C;
•Acute infection, especially bacterial;
•Oral administration of corticoid therapy in past 14 days; or
•Any of the following symptoms that interfere with normal activities: crying more than usual, sleeping more than usual, or loss of appetite.