Efficacy Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates

  • STATUS
    Recruiting
  • End date
    Jan 29, 2023
  • participants needed
    1400
  • sponsor
    PT Bio Farma
Updated on 29 August 2021

Summary

This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines

Description

This study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity following three doses of rotavirus RV3 vaccine (Bio Farma) administered as a neonatal schedule

Details
Condition Rotavirus Gastroenteritis
Treatment Placebo, Rotavirus RV3 Vaccine (Bio Farma)
Clinical Study IdentifierNCT04185545
SponsorPT Bio Farma
Last Modified on29 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Neonate 0-5 days (0-144 hours) of age at the time of first dose
Neonate is in good health as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator
The neonate was born full term (minimum of 37 completed weeks and maximum of 42 completed weeks gestation)
Neonate birth weight 2500-4000 g inclusive
Parent or guardian has been informed properly regarding the study and signed the informed consent form
Parent or guardian commits to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria

Subject concomitantly enrolled or scheduled to be enrolled in another trial
The subject has direct relatives relationship with the study team
The subject has evolving mild, moderate or severe illness, especially infectious diseases or fever (body temperature 37.5C) within the 48 hours preceding enrollment
Subject with a known or suspected history of allergy to any component of the vaccines (based on anamnesis)
Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) or Hepatitis B infection
Subject with known or suspected major congenital malformations or genetically determined disease
Subject with intussusception
Subject with a known or suspected disease of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy
Subject with a known or suspected disease of the immune system or those who have received immunosuppressive therapy, including immunosuppressive courses of systemic corticosteroid
Subject who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product is anticipated during the course of study
Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
Subject immunized with non-EPI vaccines
Gastroenteritis in the 24 hours preceding dosing (temporary exclusion criteria)
Subject planning to move from the study area before the end of the study period
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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