Safety Issues
Conditions
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.
Interventions
BIOLOGICALRotavirus (Bio Farma) Vaccine
Rotavirus (Bio Farma) Vaccine
OTHERPlacebo
Placebo contains 30% sucrose in DMEM
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The study for the neonates is double-blind, randomized study. While, the study for the adults and childrens is open-labeled study
Intervention model description
* Adults and Children Group: Experimental, open labeled, prospective intervention study * Neonates Group: Experimental, randomized, double blind, prospective intervention study
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) following immunization | 4-6 weeks after last immunization | Geometric mean titer (GMT) 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 |
| 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) |
| Serum neutralizing antibody (SNA) following immunization | 4-6 weeks after last immunization | Serum neutralizing antibody (SNA) before and after last immunization |
| 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 |
| 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) |
Countries
Indonesia
Outcome results
None listed