Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates

PT Bio Farma

Status and phase: Completed; Phase 3

Conditions: Rotavirus Gastroenteritis

Treatments: Biological: Rotavirus RV3 Vaccine (Bio Farma); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04185545

RV 0319

Details and patient eligibility

About

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

Full 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

Enrollment: 1,400 patients

Sex: All

Ages: 1 minute to 5 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,400 participants in 6 patient groups, including a placebo group

Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 1

Experimental group

Description:

3 oral doses of RV3 vaccine (Bio Farma) batch 1; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.

Treatment:

Biological: Rotavirus RV3 Vaccine (Bio Farma)

Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 2

Experimental group

Description:

3 oral doses of RV3 vaccine (Bio Farma) batch 2; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.

Treatment:

Biological: Rotavirus RV3 Vaccine (Bio Farma)

Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 3

Experimental group

Description:

3 oral doses of RV3 vaccine (Bio Farma) batch 3; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.

Treatment:

Biological: Rotavirus RV3 Vaccine (Bio Farma)

Immunogenicity Group - Placebo

Placebo Comparator group

Description:

3 oral doses of Placebo; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.

Treatment:

Other: Placebo

Other Efficacy Group - RV3 Vaccine (Bio Farma)

Experimental group

Description:

3 oral doses of RV3 vaccine (Bio Farma) administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.

Treatment:

Biological: Rotavirus RV3 Vaccine (Bio Farma)

Other Efficacy Group - Placebo

Placebo Comparator group

Description:

3 oral doses of Placebo administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.

Treatment:

Other: Placebo