Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates
NCT ID: NCT04185545
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1400 participants
INTERVENTIONAL
2020-10-30
2023-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 1
3 oral doses of RV3 vaccine (Bio Farma) batch 1; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Rotavirus RV3 Vaccine (Bio Farma)
Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains \> 5x10\^6 fcfu/mL rotavirus vaccine strain RV3
Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 2
3 oral doses of RV3 vaccine (Bio Farma) batch 2; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Rotavirus RV3 Vaccine (Bio Farma)
Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains \> 5x10\^6 fcfu/mL rotavirus vaccine strain RV3
Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 3
3 oral doses of RV3 vaccine (Bio Farma) batch 3; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Rotavirus RV3 Vaccine (Bio Farma)
Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains \> 5x10\^6 fcfu/mL rotavirus vaccine strain RV3
Immunogenicity Group - Placebo
3 oral doses of Placebo; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Placebo
Each 1 mL dose of placebo contains 30% of sucrose in DMEM
Other Efficacy Group - RV3 Vaccine (Bio Farma)
3 oral doses of RV3 vaccine (Bio Farma) administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Rotavirus RV3 Vaccine (Bio Farma)
Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains \> 5x10\^6 fcfu/mL rotavirus vaccine strain RV3
Other Efficacy Group - Placebo
3 oral doses of Placebo administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Placebo
Each 1 mL dose of placebo contains 30% of sucrose in DMEM
Interventions
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Rotavirus RV3 Vaccine (Bio Farma)
Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains \> 5x10\^6 fcfu/mL rotavirus vaccine strain RV3
Placebo
Each 1 mL dose of placebo contains 30% of sucrose in DMEM
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. The neonate was born full term (minimum of 37 completed weeks and maximum of 42 completed weeks gestation).
4. Neonate birth weight 2500-4000 g inclusive.
5. Parent or guardian has been informed properly regarding the study and signed the informed consent form.
6. Parent or guardian commits to comply with the instructions of the investigator and the schedule of the trial.
Exclusion Criteria
2. The subject has direct relatives relationship with the study team.
3. 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.
4. Subject with a known or suspected history of allergy to any component of the vaccines (based on anamnesis).
5. Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) or Hepatitis B infection.
6. Subject with known or suspected major congenital malformations or genetically determined disease.
7. Subject with intussusception.
8. Subject with a known or suspected disease of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
9. Subject with a known or suspected disease of the immune system or those who have received immunosuppressive therapy, including immunosuppressive courses of systemic corticosteroid.
10. 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.
11. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
12. Subject immunized with non-EPI vaccines.
14. Subject planning to move from the study area before the end of the study period.
1 Minute
5 Days
ALL
Yes
Sponsors
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PT Bio Farma
INDUSTRY
Responsible Party
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Principal Investigators
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Titis Widowati
Role: PRINCIPAL_INVESTIGATOR
Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM
Hari Wahyu N.
Role: PRINCIPAL_INVESTIGATOR
Pediatric Research Center Universitas Sebelas Maret (PRC UNS)
Locations
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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
Countries
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Other Identifiers
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RV 0319
Identifier Type: -
Identifier Source: org_study_id