infant diarrhea caused by rotavirus
Conditions
Interventions
Adult:Oral the hexavalent bovine rotavirus (BRV) vaccine vs placebo control
toddlers:Oral the hexavalent bovine rotavirus (BRV) vaccine vs placebo control
infants:Oral the hexavalent bovine rotavirus (BRV) vaccine vs placebo control
Sponsors
Hebei Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult =18 years old and toddlers children from 2 to 6 years old, who may have rotavirus vaccine immunization history and have no vaccine administration contraindications. Infant from 6 to 12 weeks old without rotavirus vaccine immunization history or vaccine administration contraindications; The guardian or the subject himself/herself informed consent and signed the informed consent; The subject, guardian and their family can are able to comply with the requirements of clinical trial protocol; The infant has no history of immunoglobulin administration after birth, and no vaccination with vaccine within 14 days; Auxillary temperature <=37.0 degree C.
Exclusion criteria
Exclusion criteria: The subject or his/her family has the history of allergy, convulsion, epilepsy, andor mental disease; The subject has the history of intussusception or any chronic gastrointestinal disease, including congenital malformations which cause intussusception (e.g.: Meckel diverticulum); The subject is allergic to any component of the test study vaccine, or has history of servere allergy to any vaccine; The subject has immune deficiency, or is having immunosuppressive therapy; The subject has acute febrile disease or contagious infectious disease; the subject is suffering from diarrhea or vomiting and other gastrointestinal disease; the subject had gastroenteritis or any other acute infectious disease in the past 7 days, and is being treated with antibiotics or antiviral therapy; The subject has a history of abnormal labor or asphyxia rescue, congenital malformation, developmental disorders or severe chronic disease (e.g., Down syndromes, diabetes, sickle cell anemia or neurologic disease, Guillain-Barrés syndrome); The subject is treated with any other test study drugs within 14 days; The subject had a fever (auxillary temperature =38.0?) in the past 3 days; There is significant abnormal result in the blood routine test and hepatonephric test before the immunization of adult groups and toddler children groups; The subject is known to or suspected to have the following disease: respiratory disease, acute infection or active period of chronic disease, cardiovascular disease, hepatonephric disease, skin disease, sever indigestion or gastrointestinal disease; Any situation considered by the investigator that may impact the test study evaluation; Woman of childbearing age who is pregnant or intends to get pregnant in the near future.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;immunogenicity; | — |
Countries
China
Contacts
Public ContactZhao Yuliang
Hebei Center for Disease Control and Prevention
Outcome results
None listed