Comparison of immunogenicity and safety between Sabin and Salk inactivated poliovirus vaccine in the combined bivalent oral poliovirus vaccine schedule in infant immunization: A double blind randomized controlled non-inferiority trial

World Health Organization0 个研究点目标入组 460 人开始时间: 2022年6月29日最近更新: 2024年4月15日

试验速览

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•a. Healthy infant as assessed by study physician during the clinic visit for his/her first dose of bivalent Oral Poliovirus Vaccine (bOPV).
•b. Infant between 6-8 weeks of age at first contact.
•c. Weight at enrolment visit greater than or equal to 3.0 kgs.
•d. Children residing nearby at easily accessible distance (approximately around 30 kms distance) so that these parents are able to attend all scheduled study visits and comply with the study procedures for full length of the study.
•e. Parents or primary care givers of these infants who provide written informed consent for their children’s participation in the trial.

•a.Parents and infants who are unable to participate for the full length of the study.
•b.Infant who has previously received a prior dose of polio vaccine
•c.A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
•d.A diagnosis or suspicion of bleeding or a coagulation disorder.
•e.Acute infection or illness at the time of enrolment that would require infant’s admission to a hospital.
•f.Evidence of a chronic medical condition identified by a study medical officer during physical exam.
•g.Known allergy/sensitivity or reaction to polio vaccines.

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