Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
- Conditions
- Safety Issues
- Interventions
- Biological: Rotavirus (Bio Farma) VaccineOther: Placebo
- Registration Number
- NCT03462108
- Lead Sponsor
- PT Bio Farma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rotavirus (Bio Farma) Vaccine-Neonates Rotavirus (Bio Farma) Vaccine 3 doses of 1 ml of Rotavirus vaccine per oral Rotavirus (Bio Farma) Vaccine-Adult Rotavirus (Bio Farma) Vaccine 1 doses of 1 ml of Rotavirus vaccine per oral Rotavirus (Bio Farma) Vaccine-Children Rotavirus (Bio Farma) Vaccine 1 doses of 1 ml of Rotavirus vaccine per oral Placebo-Neonates Placebo 3 doses of 1 ml of Placebo (contains 30% sucrose in DMEM) per oral
- Primary Outcome Measures
Name Time Method Solicited symptoms after each immunization 0-7 days Number of subjects with solicited systemic and gastrointestinal symptoms in the day 0-7 following each dose of investigational product
- Secondary Outcome Measures
Name Time Method Serious adverse events of Rotavirus (Bio Farma) vaccine 28 days Number and percentage of subjects with Serious Adverse Events (SAE) within 28 days after each dose of investigational product
Adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group 28 days Number and percentage of subject with adverse event (AE) within 28 days after each dose of investigational product compare to placebo (in neonates group)
Serious adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group 28 days Number and percentage of subject with Serious Adverse Events (SAE) within 28 days after each dose of investigational product compare to placebo (in neonates group)
Serum neutralizing antibody (SNA) following immunization 4-6 weeks after last immunization Serum neutralizing antibody (SNA) before and after last immunization
Adverse events of Rotavirus (Bio Farma) vaccine 28 days Number and percentage of subjects with unsolicited Adverse Events (AE) in the day 0-28 following each dose of investigational product
Number of subject who has abnormality value of routine hematology and biochemical evaluation that probably related to the vaccination 7 days Deviation in routine hematology and biochemical evaluation
Excretion of rotavirus in stools in neonates group 3-7 days Number of neonates with rotavirus excretion in stools
Number of subjects with >=3 times increasing antibody from baseline to post investigational product dosing 4-6 weeks after last immunization Subjects with \>=3 times increasing antibody from baseline to post investigational product dosing
Serum anti-rotavirus immunoglobulin (Ig)A following immunization 4-6 weeks after last immunization Serum anti-rotavirus immunoglobulin (Ig)A before and after last immunization
Geometric Mean Titer (GMT) following immunization 4-6 weeks after last immunization Geometric mean titer (GMT) before and after last immunization
Trial Locations
- Locations (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