Rotavirus Gastroenteritis
Conditions
Keywords
Rotavirus, Vaccine
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
Interventions
BIOLOGICALRotavirus 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
OTHERPlacebo
Each 1 mL dose of placebo contains 30% of sucrose in DMEM
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 5 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of three doses against severe acute rotavirus gastroenteritis | 2 weeks after three doses to 18 months of age | Episodes of severe rotavirus gastroenteritis (defined as a modified Vesikari score ≥ 11 and rotavirus antigen detected in stool by ELISA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of three doses against rotavirus gastroenteritis of any severity and all-cause gastroenteritis | 2 weeks after three doses to 18 months of age | Episodes of rotavirus gastroenteritis of any severity (based on modified Vesikari score and rotavirus antigen detected in stool by ELISA) and all-cause gastroenteritis |
| Serum immune response (sIgA) after third dose | 28 days after the third dose | Percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the third dose |
| Stool excretion following each dose | 3-5 days after each dose | Detectable RV3 excretion in stool (by PCR) any day from day 3 to day 5 following each dose |
| Lot to lot consistency | 28 days after the third dose | Percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the third dose |
| Solicited and unsolicited adverse events (AE) | Up to 28 days after the third dose | Number of solicited and unsolicited Adverse Events (AE), from randomization to 28 days following last dose |
| Serious adverse events (SAE) | Up to 28 days after the third dose | Number of Serious Adverse Events (SAE), from randomization to 28 days following last dose |
| Cumulative serum immune response | 28 days after each dose | Cumulative serum anti-rotavirus IgA (sIgA) following each dose |
| Serum immune response (sIgA) after the second dose | 28 days after the second dose | Percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the second dose |
| Abnormality of ALT and AST levels | 28 days after the first dose | Abnormality of ALT and AST levels measured 28 days following first dose, assessed as probably or definitely related to the dosing |
| Immune interference | 28 days after non-EPI vaccination | Percentage of subjects with reciprocal titre ≥ 1:8 against poliovirus strains 1-3 measured 28 days after bOPV4+ IPV and Pentabio 3 vaccination |
| Geometric Mean Titre (GMT) | 28 days after each dose | Geometric Mean Titre (GMT) of serum IgA 28 days after each dose |
| Serum neutralizing antibodies (SNA) after the third dose | 28 days after the third dose | Percentage of subjects with positive SNA (≥ 100), two-fold and three-fold increasing antibodies from baseline to 28 days after the third dose |
| Serum immune response (sIgA) after the first dose | 28 days after the first dose | Percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the first dose |
Countries
Indonesia
Outcome results
None listed