CompletedPhase 3

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

Indonesia1,400 participantsStarted 2020-10-30

Plain-language 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

Who can participate

Age range1 Minute – 5 Days

SexALL

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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 37.5°C) 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.

What they're measuring

Efficacy of three doses against severe acute rotavirus gastroenteritis

Timeframe: 2 weeks after three doses to 18 months of age

Trial details

NCT IDNCT04185545

SponsorPT Bio Farma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-30

View on ClinicalTrials.gov More Rotavirus Gastroenteritis trials