Comparison of immunogenicity of Monovalent oral polio vaccine (mOPVI) administered at short intervals with Monovalent (mOPVI) and Bivalent (bOPV1,3) oral polio vaccine given at standard intervals in healthy infants in Pakistan: a randomized trial

Department of Paediatrics and Child Health, Aga Khan University0 个研究点目标入组 800 人开始时间: 2011年8月4日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Infants born healthy (> 2.5 kg birth weight, immediate cry, no neonatal IMCI danger signs) at the study sites (home or health facility births assisted by study-Trained Birth Attendants/other health personnel) and not planning to travel away during entire the study period (birth-102 days).

•High-risk newborns will be excluded, as well as newborns requiring hospitalization, birth weight below 2.5 kg, cry >2 minutes, and with any neonatal IMNCI danger signs, residence >30 km from study site, or family is planning to be absent during the birth - 102 day study period. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family - e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study. Subjects will be re-screened for eligibility at the 6 week visit before randomization to study arms. Infants with illness requiring hospitalization, weight <2.5 kg, family planning to be away during the next 10 weeks, or unwilling to have another blood draw will be excluded from randomization. The families of babies with exclusion criteria will be informed about immediate treatment options if their baby is sick (hospital referral and in case of refusal centre-based outpatient care), need for receipt of routine immunizations, and reassured about long term continued assessment and primary level care at the PHC.

发起方

Department of Paediatrics and Child Health, Aga Khan University