A pneumococcal conjugate vaccine (PCV) probe study to define the role of under-fives in within-household transmission of Streptococcus pneumoniae to infants in high disease burden settings (PNEUMOCOCOON)

iverpool School of Tropical Medicine0 个研究点目标入组 2,588 人开始时间: 2023年2月9日最近更新: 2023年2月20日

试验速览

暂无简介。

•All participants:
•1. Adult participants (>18 years old) with written informed consent and children with parental/legal guardian’s written informed consent
•2. Residence in Blantyre District
•1. <32 weeks gestation
•2. Household contacts 12-59 months old (HHC)
•3. 18-45 years old
•1. 12-59 months old at time of entry into the study
•2. Record of PCV13 infant immunisation
•3. Lives in the same household as study mothers
•1. <14 days old at recruitment

•Mothers and household contacts 12-59 months old (HHC):
•1. Ongoing antibiotic treatment
•2. Ongoing TB treatment including isoniazid prophylaxis
•3. Immunosuppressive illnesses e.g., HIV infection
•4. Immunosuppressive treatment e.g., steroids
•5. Women with prior PCV vaccination
•6. Women with the following comorbidities: a hypertensive disorder (including pre-eclampsia and eclampsia), diabetes (including gestational diabetes), a previous history of preterm delivery, incompetent cervix/cervical cerclage placement, or multiple gestations (twins or more babies)
•7. Residence in a PAVE 2+1 catchment area
•1. Previous severe adverse reaction to PCV13 or the pentavalent vaccine
•2. Known hypersensitivity to any components of the Prevnar 13 or the pentavalent combination vaccine, or a severe reaction to a previous dose of either vaccines or any of their constituents.
•3. <2 or >4 doses of PCV
•1. Preterm birth (<37 weeks)
•2. Congenital abnormalities of the upper airways

发起方

iverpool School of Tropical Medicine