Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
A Prospective Intervention Phase I Study in Three Age De-escalating Group to Assess the Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
1 other identifier
interventional
100
1 country
4
Brief Summary
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2018
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2017
CompletedFirst Posted
Study publicly available on registry
March 12, 2018
CompletedStudy Start
First participant enrolled
April 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedApril 3, 2019
April 1, 2018
11 months
September 29, 2017
April 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Solicited symptoms after each immunization
Number of subjects with solicited systemic and gastrointestinal symptoms in the day 0-7 following each dose of investigational product
0-7 days
Secondary Outcomes (10)
Adverse events of Rotavirus (Bio Farma) vaccine
28 days
Serious adverse events of Rotavirus (Bio Farma) vaccine
28 days
Adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group
28 days
Serious adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group
28 days
Number of subject who has abnormality value of routine hematology and biochemical evaluation that probably related to the vaccination
7 days
- +5 more secondary outcomes
Study Arms (4)
Rotavirus (Bio Farma) Vaccine-Adult
EXPERIMENTAL1 doses of 1 ml of Rotavirus vaccine per oral
Rotavirus (Bio Farma) Vaccine-Children
EXPERIMENTAL1 doses of 1 ml of Rotavirus vaccine per oral
Rotavirus (Bio Farma) Vaccine-Neonates
EXPERIMENTAL3 doses of 1 ml of Rotavirus vaccine per oral
Placebo-Neonates
PLACEBO COMPARATOR3 doses of 1 ml of Placebo (contains 30% sucrose in DMEM) per oral
Interventions
Rotavirus (Bio Farma) Vaccine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PT Bio Farmalead
Study Sites (4)
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jarir At Thobari
Pediatric Research Office (PRO), Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran UGM/RSUP Dr. Sardjito
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The study for the neonates is double-blind, randomized study. While, the study for the adults and childrens is open-labeled study
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2017
First Posted
March 12, 2018
Study Start
April 9, 2018
Primary Completion
February 18, 2019
Study Completion
March 30, 2019
Last Updated
April 3, 2019
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share