Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates
1 other identifier
interventional
1,400
1 country
21
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2020
Typical duration for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2019
CompletedFirst Posted
Study publicly available on registry
December 4, 2019
CompletedStudy Start
First participant enrolled
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedNovember 29, 2023
November 1, 2023
1.5 years
November 27, 2019
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of three doses against severe acute rotavirus gastroenteritis
Episodes of severe rotavirus gastroenteritis (defined as a modified Vesikari score ≥ 11 and rotavirus antigen detected in stool by ELISA)
2 weeks after three doses to 18 months of age
Secondary Outcomes (13)
Efficacy of three doses against rotavirus gastroenteritis of any severity and all-cause gastroenteritis
2 weeks after three doses to 18 months of age
Serum immune response (sIgA) after third dose
28 days after the third dose
Stool excretion following each dose
3-5 days after each dose
Cumulative serum immune response
28 days after each dose
Lot to lot consistency
28 days after the third dose
- +8 more secondary outcomes
Study Arms (6)
Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 1
EXPERIMENTAL3 oral doses of RV3 vaccine (Bio Farma) batch 1; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 2
EXPERIMENTAL3 oral doses of RV3 vaccine (Bio Farma) batch 2; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 3
EXPERIMENTAL3 oral doses of RV3 vaccine (Bio Farma) batch 3; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Immunogenicity Group - Placebo
PLACEBO COMPARATOR3 oral doses of Placebo; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Other Efficacy Group - RV3 Vaccine (Bio Farma)
EXPERIMENTAL3 oral doses of RV3 vaccine (Bio Farma) administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Other Efficacy Group - Placebo
PLACEBO COMPARATOR3 oral doses of Placebo administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Interventions
Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains \> 5x10\^6 fcfu/mL rotavirus vaccine strain RV3
Each 1 mL dose of placebo contains 30% of sucrose in DMEM
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- Subject planning to move from the study area before the end of the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PT Bio Farmalead
Study Sites (21)
Dr. Moewardi District Hospital
Surakarta, Indonesia
Gajahan Primary Health Center
Surakarta, Indonesia
Gambirsari Primary Health Center
Surakarta, Indonesia
Pajang Primary Health Center
Surakarta, Indonesia
Sangkrah Primary Health Center
Surakarta, Indonesia
Sibela Primary Health Center
Surakarta, Indonesia
Bayat Primary Health Center
Yogyakarta, Indonesia
dr. Soeradji Tirtonegoro General Hospital
Yogyakarta, Indonesia
Gantiwarno Primary Health Center
Yogyakarta, Indonesia
Jogonalan 1 Primary Health Center
Yogyakarta, Indonesia
Jogonalan 2 Primary Health Center
Yogyakarta, Indonesia
Karanganom Primary Health Center
Yogyakarta, Indonesia
Kebonarum Primary Health Center
Yogyakarta, Indonesia
Kebondalem Lor Primary Health Center
Yogyakarta, Indonesia
Klaten Selatan Primary Health Center
Yogyakarta, Indonesia
Ngawen Primary Health Center
Yogyakarta, Indonesia
Pedan Primary Health Center
Yogyakarta, Indonesia
Prambanan Primary Health Center
Yogyakarta, Indonesia
Trucuk 1 Primary Health Center
Yogyakarta, Indonesia
Trucuk 2 Primary Health Center
Yogyakarta, Indonesia
Wedi Primary Health Center
Yogyakarta, Indonesia
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Titis Widowati
Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM
- PRINCIPAL INVESTIGATOR
Hari Wahyu N.
Pediatric Research Center Universitas Sebelas Maret (PRC UNS)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2019
First Posted
December 4, 2019
Study Start
October 30, 2020
Primary Completion
April 30, 2022
Study Completion
May 30, 2023
Last Updated
November 29, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share