Clinical trial NCT04185545: Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates
Official title: Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates, Lot to Lot Consistency and Antigen Interference With Co-Administered EPI Vaccines (Phase III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus Gastroenteritis
Keywords: Rotavirus
Vaccine
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 1400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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

Eligibility criteria: Inclusion Criteria:

1. Neonate 0-5 days (0-144 hours) of age at the time of first dose.
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:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
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.
13. Gastroenteritis in the 24 hours preceding dosing (temporary exclusion criteria).
14. Subject planning to move from the study area before the end of the study period.

Primary outcomes:
measure: Efficacy of three doses against severe acute rotavirus gastroenteritis
timeFrame: 2 weeks after three doses to 18 months of age
Secondary outcomes:
measure: Efficacy of three doses against rotavirus gastroenteritis of any severity and all-cause gastroenteritis
timeFrame: 2 weeks after three doses to 18 months of age
measure: Serum immune response (sIgA) after third dose
timeFrame: 28 days after the third dose
measure: Stool excretion following each dose
timeFrame: 3-5 days after each dose
measure: Cumulative serum immune response
timeFrame: 28 days after each dose
measure: Lot to lot consistency
timeFrame: 28 days after the third dose
measure: Solicited and unsolicited adverse events (AE)
timeFrame: Up to 28 days after the third dose
measure: Serious adverse events (SAE)
timeFrame: Up to 28 days after the third dose
measure: Serum immune response (sIgA) after the first dose
timeFrame: 28 days after the first dose
measure: Serum immune response (sIgA) after the second dose
timeFrame: 28 days after the second dose
measure: Abnormality of ALT and AST levels
timeFrame: 28 days after the first dose
measure: Immune interference
timeFrame: 28 days after non-EPI vaccination
measure: Geometric Mean Titre (GMT)
timeFrame: 28 days after each dose
measure: Serum neutralizing antibodies (SNA) after the third dose
timeFrame: 28 days after the third dose
Other outcomes:
Locations:
city: Surakarta
country: Indonesia
facility: Dr. Moewardi District Hospital
city: Surakarta
country: Indonesia
facility: Gajahan Primary Health Center
city: Surakarta
country: Indonesia
facility: Gambirsari Primary Health Center
city: Surakarta
country: Indonesia
facility: Pajang Primary Health Center
city: Surakarta
country: Indonesia
facility: Sangkrah Primary Health Center
city: Surakarta
country: Indonesia
facility: Sibela Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Bayat Primary Health Center
city: Yogyakarta
country: Indonesia
facility: dr. Soeradji Tirtonegoro General Hospital
city: Yogyakarta
country: Indonesia
facility: Gantiwarno Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Jogonalan 1 Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Jogonalan 2 Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Karanganom Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Kebonarum Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Kebondalem Lor Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Klaten Selatan Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Ngawen Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Pedan Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Prambanan Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Trucuk 1 Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Trucuk 2 Primary Health Center
city: Yogyakarta
country: Indonesia
facility: Wedi Primary Health Center
Study officials:
affiliation: Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM
name: Titis Widowati
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Research Center Universitas Sebelas Maret (PRC UNS)
name: Hari Wahyu N.
role: PRINCIPAL_INVESTIGATOR
References: