Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates

NCT ID: NCT03462108

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2019-03-30

Brief Summary

This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.

Detailed Description

To describe the safety of this vaccine after each immunization. To assess preliminary information of immunogenicity following Rotavirus (Bio Farma) vaccine immunization.

Conditions

Safety Issues

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Rotavirus (Bio Farma) Vaccine-Adult

1 doses of 1 ml of Rotavirus vaccine per oral

Group Type: EXPERIMENTAL

Rotavirus (Bio Farma) Vaccine

Intervention Type: BIOLOGICAL

Rotavirus (Bio Farma) Vaccine

Rotavirus (Bio Farma) Vaccine-Children

1 doses of 1 ml of Rotavirus vaccine per oral

Group Type: EXPERIMENTAL

Rotavirus (Bio Farma) Vaccine

Intervention Type: BIOLOGICAL

Rotavirus (Bio Farma) Vaccine

Rotavirus (Bio Farma) Vaccine-Neonates

3 doses of 1 ml of Rotavirus vaccine per oral

Group Type: EXPERIMENTAL

Rotavirus (Bio Farma) Vaccine

Intervention Type: BIOLOGICAL

Rotavirus (Bio Farma) Vaccine

Placebo-Neonates

3 doses of 1 ml of Placebo (contains 30% sucrose in DMEM) per oral

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo contains 30% sucrose in DMEM

Interventions

Rotavirus (Bio Farma) Vaccine

Rotavirus (Bio Farma) Vaccine

Intervention Type: BIOLOGICAL

Placebo

Placebo contains 30% sucrose in DMEM

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy Adults as determined by clinical judgment, including a medical history, physical exam and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator.
• Subjects have been informed properly regarding the study and signed the informed consent form.
• Subject will commit to comply with the instructions of the investigator and the schedule of the trial.

• Healthy Children 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.
• Parents/guardian(s) have been informed properly regarding the study and signed the informed consent form
• Parent/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

• Neonate 0-5 days of age at the time of first dose, with cord blood available
• 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.
• The neonate was born full term (minimum of 36 completed weeks and maximum of 42 completed weeks gestation).
• Neonate birth weight 2500-4000 g inclusive.
• Parents or guardians have been informed properly regarding the study and signed the informed consent form
• Parents or guardians will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria

• Subject concomitantly enrolled or scheduled to be enrolled in another trial
• Any direct relatives relationship with the study team.
• Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
• Known history of allergy to any component of the vaccines
• Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
• Gastroenteritis in the 24 hours preceding enrollment.
• History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
• Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or corticosteroid therapy and other immunosuppresant).
• Subject consuming or expect to consume a probiotics within one week before and after vaccination
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
• Pregnancy & lactation (Adults).
• Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
• Subject planning to move from the study area before the end of study period.

• Subject concomitantly enrolled or scheduled to be enrolled in another trial
• Any direct relatives relationship with the study team
• Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C ) within the 48 hours preceding enrollment
• Known history of allergy to any component of the vaccines
• Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
• Gastroenteritis in the 24 hours preceding enrollment.
• Any clinically significant history of chronic gastrointestinal disease including uncorrected congenital malformation of gastrointestinal tract that would predispose for Intusussception.
• History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
• Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant).
• Subjects consuming or expect to consume a probiotics within one week before and after vaccination.
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
• Individuals who have previously received any rotavirus vaccine.
• Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
• Subject planning to move from the study area before the end of study period

• Subject concomitantly enrolled or scheduled to be enrolled in another trial.
• Any direct relatives relationship with the study team.
• Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
• Subject with known or suspected history of allergy to any component of the vaccines.
• Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) infection.
• Subject with known or suspected major congenital malformations or genetically determined disease.
• Subject with intussusception.
• Subject with a known or suspected disease of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
• Subject with a known or suspected disease of the immune system or those who has received immunosuppresive therapy, including immunosuppresive courses of systemic corticosteroid.
• Subject who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product during the course of study.
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
• Subject immunized with non- EPI vaccines.
• Gastroenteritis in the 24 hours preceding enrollment.
• Subject planning to move from the study area before the end of study period.

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PT Bio Farma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jarir At Thobari

Role: PRINCIPAL_INVESTIGATOR

Pediatric Research Office (PRO), Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran UGM/RSUP Dr. Sardjito

Locations

Gantiwarno Primary Health Center

Klaten, Central Java, Indonesia

Klaten Selatan Primary Health Center

Klaten, Central Java, Indonesia

Ngawen Primary Health Center

Klaten, Central Java, Indonesia

RS Soeradji Tritonegoro

Klaten, Central Java, Indonesia

Countries

Indonesia

Other Identifiers

RV 0117

Identifier Type: -

Identifier Source: org_study_id