Healthy volunteers.
Conditions
Interventions
Intervention group: single dose Rahpouyan Fanavar Sadegh (RFS) Co. Rota-virus vaccine
1.5 cc per oral.
Sponsors
Rahpouyan Fanavar Sadegh (RFS) Co.
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Iranian male or female volunteer Age range: 18 - 40 years old Signed informed consent General health based on clinical examination
Exclusion criteria
Exclusion criteria: Administration immunosuppressive treatments 4 weeks before vaccination Taking Immunoglobulin and/or blood products during last 2 weeks History for immune system deficiency History of hypersensitivity to vaccine components (e.g: sucrose, citric acid, gelatin,...) History of anaphylaxis or shock against antibiotics Fever in last 3 days Respiratory infection at vaccination day Pregnancy or intention to pregnancy in females Females in lactating period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited serious adverse events related to study intervention i.e. anaphylactic reactions, severe diarrhea, dehydration, fever, hematochezia bronchiolitis, pneumonitis, urinary infections, seizure, intestinal invagination (severe abdominal pain, vomiting, hematochezia, abdominal distension) , death up to 4 weeks after taking study vaccine. Timepoint: During 4 weeks of study follow up. Method of measurement: Physical examination, lab results and medical history. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute adverse reactions related to oral vaccine intake, up to one week including: fatigue, diarrhea and vomiting, coryza, cough, flatulence and anorexia. Timepoint: During one week follow up after intervention. Method of measurement: Clinical examination and medical history.;Acute diarrhea due to rotavirus till 4 weeks after intervention. Timepoint: During 4 weeks follow up after intervention. Method of measurement: Medical history and Stool exam to detect Rota virus antigens.;Other acute diarrhea after vaccine up to 4 weeks. Timepoint: During 4 weeks follow up after intervention. Method of measurement: Medical history and Stool exam to detect Rota virus antigens.;Other unsolicited adverse events reported up to 4 weeks after intervention. Timepoint: During 4 weeks follow up after intervention. Method of measurement: Clinical examination and medical history.;Change in blood cells indices (CBC). Timepoint: Before intervention, 4 weeks after intervention. Method of measurement: Complete Blood Count (CBC) test.;Change in BUN, Creatinin, SGOT, SGPT during 4 weeks after intervention. Timepoint: Before intervention, 4 weeks after intervention. Method of measurement: Biochemical tests on blood sample. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Ramin Heshmat
Tehran University of Medical Sciences
Outcome results
None listed