A Phase 2a, Randomized, Controlled, Observer Blind, Age De-Escalation, Multicenter and Multinational Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants

ovartis Vaccine Institute for Global Health0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
•2. Residence in the study area.
•3. Males and females of age >=18 to <=45 years
•4. Individuals who, after the nature of the study has been explained to them, have given written informed consent according to local regulatory requirements
•5. Females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team)

•1.Individuals who have a previously ascertained or suspected disease caused by S. Typhi
•2.Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi
•3.Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion.
•4.Non residence in the study area or intent to move out within 3 months
•5.Previous inclusion of three family members in the study (i.e., subjects belonging to the same family. Biological father, mother, child, and brothers and sisters may be included up to a maximum of three members from the same family).
•6.Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines
•7.Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
•8.Individuals with history of substance or alcohol abuse within the past 2 years.
•9.Women who are pregnant or breast-feeding or of childbearing age who are not willing to participate in family planning consultations (organized by the site study team)
•10.Females with history of stillbirth, neonatal loss, or previous infant with anomaly

发起方

ovartis Vaccine Institute for Global Health