gastroenteritis caused by rotavirus
Conditions
Interventions
Experimental group:vaccine
Control group:placebo
Sponsors
Hebei Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 6 to 12 weeks (birth weight >=2500g, gestational age 37-42 weeks) when receiving the first dose of live rotavirus vaccine/placebo; 2. The guardian gives informed consent and signs the informed consent, and is able to comply with the requirements of the test protocol.
Exclusion criteria
Exclusion criteria: 1. History of congenital gastrointestinal diseases, previous rotavirus gastroenteritis, chronic diarrhea, stunting or abdominal surgery; 2. A history of intussusception, including congenital gastrointestinal malformations prone to intussusception (e.g., Meckel's diverticulum); 3. Known or suspected immune dysfunction, including severe combined immunodeficiency disease (SCID); 4. The subject has acute disease, severe chronic disease or is in the acute phase of chronic disease; 5. Subject has uncontrollable epilepsy, encephalopathy, epileptic seizure or other progressive neurological disease; 6. Known history of drug allergy; 7. Previous vaccination against any rotavirus; 8. There is clinical evidence of active gastrointestinal disease. Note: Infants with gastroesophageal reflux disease [GERD] can also participate in this study if GERD can be well controlled with or without medication; 9. Infants who have received intramuscular, oral or intravenous corticosteroids since birth. Note: The use of topical, ophthalmic or inhaled steroids is permitted. 10. Family history of congenital or inherited immune deficiency; 11. Previous blood transfusion or use of blood products, including immunoglobulin (except hepatitis B immunoglobulin); 12. Participate in another intervention study within 14 days prior to dose 1 of the study vaccine or at any time expected during the study; 13. Use of investigational or non-registered drugs other than the investigational vaccine within 30 days prior to the first dose of the investigational vaccine or at any time planned during the study; 14. Members (such as family members, babysitters, etc.) living with the subject have immune deficiency, such as malignant diseases, immunosuppressive diseases, primary immune deficiency diseases, or are receiving immunosuppressive treatment; 15. Any situation that the investigator considers may affect the evaluation of the study purpose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Protective effect against rotavirus diarrhea; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events/reactions;IgA titer for rotavirus; | — |
Countries
China
Contacts
Public ContactZhao Yuliang
Hebei Center for Disease Control and Prevention
Outcome results
None listed