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)

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM); Pediatric Research Center Universitas Sebelas Maret (PRC UNS)
No Registry
INA-1M7KY9N
Tanggal Input Registry : 02-11-2020

30-10-2020
To assess the efficacy of three doses of Rotavirus RV3 vaccine (Bio Farma) against severe acute rotavirus gastroenteritis, up to 18 months of age.
1. To assess the efficacy of three doses of Rotavirus RV3 vaccine (Bio Farma) compared with placebo and the outcomes reported in the Indonesian efficacy study (IIb) of the RV3-BB vaccine produced by MCRI, in regards to: (i) Rotavirus gastroenteritis of any severity, (ii) All-cause gastroenteritis. 2. To assess serum immune response (sIgA) 28 days after the third dose of Rotavirus RV3 vaccine (Bio Farma) administered in a neonatal schedule. 3. To compare Rotavirus RV3 vaccine (Bio Farma) to the outcomes reported in the Indonesian efficacy study (IIb) of the RV3-BB vaccine produced by MCRI, in regards to: (i) Serum immune response (sIgA) 28 days after the third dose of Rotavirus RV3 vaccine (Bio Farma), (ii) The incidence of stool excretion of RV3 on days 3 to 5 following each dose of Rotavirus RV3 vaccine (Bio Farma), (iii) Cumulative serum immune response (cumulative sIgA following dose 1/ dose 2/ dose 3) of Rotavirus RV3 vaccine (Bio Farma). 4. To compare Rotavirus RV3 vaccine (Bio Farma) to placebo with respect to: (i) Serum immune response (sIgA) 28 days after the third dose of Rotavirus RV3 vaccine (Bio Farma) or placebo, (ii) The incidence of stool excretion of RV3 on days 3 to 5 following each dose of Rotavirus RV3 vaccine (Bio Farma) or placebo, (iii) Cumulative serum immune response (cumulative sIgA after dose 1/dose 2/dose 3) of Rotavirus RV3 vaccine (Bio Farma) or placebo. 5. To evaluate lot-to-lot consistency using 3 batches of Rotavirus RV3 vaccine (Bio Farma) by assessment of serum immune response (sIgA) 28 days after the third dose of vaccine. 6. To describe the safety, tolerability and reactogenicity of Rotavirus RV3 Vaccine (Bio Farma) compared to placebo, between batches and co-administration with EPI vaccine, with respect to: (i) Solicited and unsolicited adverse events, from randomisation to 28 days following last dose, (ii) Serious adverse events, from randomisation to 28 days following last dose, (iii) Comparison number and percentage of subject with adverse event and Serious Adverse Events (SAE) compare to placebo, between batches, and co-administration with EPI vaccine, (iv) ALT/AST 28 days following dose 1 [in a subset of 200 immunogenicity participants]. 7. To describe the serum immune response after the first dose of Rotavirus RV3 Vaccine (Bio Farma) [subset of 200 immunogenicity participants] as follows: (i) To describe the proportion of participants with a serum immune response (sIgA) 28 days following the first dose of Rotavirus RV3 Vaccine (Bio Farma), (ii) To compare the serum immune response (sIgA) after 1 dose of Rotavirus RV3 vaccine (Bio Farma) or placebo. 8. To describe the serum immune response after the second dose of Rotavirus RV3 vaccine (Bio Farma) [subset of 200 immunogenicity participants] as follows: (i) To describe the proportion of participants with a serum immune response (sIgA) 28 days following the second dose of Rotavirus RV3 Vaccine (Bio Farma), (ii) To compare the serum immune response (sIgA) and cumulative serum immune response after 2 doses of Rotavirus RV3 vaccine (Bio Farma) or placebo. 9. To assess immune interference between Rotavirus RV3 Vaccine (Bio Farma) co-administered with EPI vaccines compared to placebo [subset of 200 immunogenicity participants]: (i) To assess immunogenicity of Oral Polio vaccine co-administered with Rotavirus RV3 Vaccine (Bio Farma), (ii) To assess immunogenicity of Rotavirus RV3 vaccine (Bio Farma) co-administered with Oral Polio vaccine. 10. To describe the Geometric mean titre (GMT) of serum IgA 28 days after each dose of Rotavirus RV3 vaccine (Bio Farma). 11. To describe Serum neutralising antibodies in 80 participants.
 
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)
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)
Eksperimental
Investigational product: Rotavirus RV3 Vaccine (Bio Farma); Control product: Placebo
1400
 

Inclusion Criteria:

1. Neonate 0-5 days 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 with 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 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 who has received immunosuppresive therapy, including immunosuppresive 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 study period.
 
KE/FK/1055/EC/2020; 931/VII/HREC/2019
NA
R-RG.01.06.3.32.10.20.862; B-RG.01.06.3.32.09.20.795
RV 0319
dr. Jarir At-Thobari, PhD; Dr. dr. Titis Widowati, Sp.A(K); dr. Hari Wahyu N., M.Kes., Sp.A(K)