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

PT Bio Farma

Status and phase: Completed; Phase 1

Conditions: Safety Issues

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03462108

RV 0117

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 patients

Sex: All

Ages: 1 minute to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Adults:

• 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.

Inclusion Criteria for Children:

• 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.

Inclusion Criteria for Neonates:

• 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 for Adults:

• 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.

Exclusion Criteria for Children:

• 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

Exclusion Criteria for Neonates:

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

Rotavirus (Bio Farma) Vaccine-Adult

Experimental group

Description:

1 doses of 1 ml of Rotavirus vaccine per oral

Treatment:

Biological: Rotavirus (Bio Farma) Vaccine

Rotavirus (Bio Farma) Vaccine-Children

Experimental group

Description:

1 doses of 1 ml of Rotavirus vaccine per oral

Treatment:

Biological: Rotavirus (Bio Farma) Vaccine

Rotavirus (Bio Farma) Vaccine-Neonates

Experimental group

Description:

3 doses of 1 ml of Rotavirus vaccine per oral

Treatment:

Biological: Rotavirus (Bio Farma) Vaccine

Placebo-Neonates

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo