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This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
To describe the safety of this vaccine after each immunization. To assess preliminary information of immunogenicity following Rotavirus (Bio Farma) vaccine immunization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotavirus (Bio Farma) Vaccine-Adult | Experimental | 1 doses of 1 ml of Rotavirus vaccine per oral |
|
| Rotavirus (Bio Farma) Vaccine-Children | Experimental | 1 doses of 1 ml of Rotavirus vaccine per oral |
|
| Rotavirus (Bio Farma) Vaccine-Neonates | Experimental | 3 doses of 1 ml of Rotavirus vaccine per oral |
|
| Placebo-Neonates | Placebo Comparator | 3 doses of 1 ml of Placebo (contains 30% sucrose in DMEM) per oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotavirus (Bio Farma) Vaccine | Biological | Rotavirus (Bio Farma) Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of Rotavirus (Bio Farma) vaccine | Number and percentage of subjects with unsolicited Adverse Events (AE) in the day 0-28 following each dose of investigational product | 28 days |
| Serious adverse events of Rotavirus (Bio Farma) vaccine |
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Inclusion Criteria for Adults:
Inclusion Criteria for Children:
Inclusion Criteria for Neonates:
Exclusion Criteria for Adults:
Exclusion Criteria for Children:
Exclusion Criteria for Neonates:
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| Name | Affiliation | Role |
|---|---|---|
| Jarir At Thobari | Pediatric Research Office (PRO), Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran UGM/RSUP Dr. Sardjito | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gantiwarno Primary Health Center | Klaten | Central Java | Indonesia | |||
| Klaten Selatan Primary Health Center |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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The study for the neonates is double-blind, randomized study. While, the study for the adults and childrens is open-labeled study
| Placebo | Other | Placebo contains 30% sucrose in DMEM |
|
Number and percentage of subjects with Serious Adverse Events (SAE) within 28 days after each dose of investigational product
| 28 days |
| Adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group | Number and percentage of subject with adverse event (AE) within 28 days after each dose of investigational product compare to placebo (in neonates group) | 28 days |
| Serious adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group | 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) | 28 days |
| Number of subject who has abnormality value of routine hematology and biochemical evaluation that probably related to the vaccination | Deviation in routine hematology and biochemical evaluation | 7 days |
| Excretion of rotavirus in stools in neonates group | Number of neonates with rotavirus excretion in stools | 3-7 days |
| Number of subjects with >=3 times increasing antibody from baseline to post investigational product dosing | Subjects with >=3 times increasing antibody from baseline to post investigational product dosing | 4-6 weeks after last immunization |
| Serum anti-rotavirus immunoglobulin (Ig)A following immunization | Serum anti-rotavirus immunoglobulin (Ig)A before and after last immunization | 4-6 weeks after last immunization |
| Serum neutralizing antibody (SNA) following immunization | Serum neutralizing antibody (SNA) before and after last immunization | 4-6 weeks after last immunization |
| Geometric Mean Titer (GMT) following immunization | Geometric mean titer (GMT) before and after last immunization | 4-6 weeks after last immunization |
| Klaten |
| Central Java |
| Indonesia |
| Ngawen Primary Health Center | Klaten | Central Java | Indonesia |
| RS Soeradji Tritonegoro | Klaten | Central Java | Indonesia |