Rotavirus gastroenteritis
Conditions
Interventions
Low dose test group:Vaccination with low-dose experimental vaccine
High dose test group:Vaccination with high-dose experimental vaccine
control group:Vaccination with positive control vaccine
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1. Healthy infants aged 6-12 weeks; 2. The guardian is able to understand and voluntarily sign the informed consent form; 3. Willing and able to comply with all follow-up plans, sample collection, vaccination, and other research procedures; 4. Provide legal identification documents;
Exclusion criteria
Exclusion criteria: 1. Previously received rotavirus vaccine; 2. Previous rotavirus infection; 3. Fetal age at birth<37 weeks or = 42 weeks; 4. History of difficult childbirth, suffocation rescue, and neurological damage at birth; 5. Known allergies to vaccines or vaccine ingredients, such as urticaria, dyspnea, angioedema, etc; 6. Those who currently suffer from diarrhea, vomiting, and other digestive system diseases, have experienced acute attacks of gastroenteritis or any other acute or chronic disease within 7 days before vaccination, and are currently receiving antibiotic or antiviral treatment; 7. History of intussusception or chronic gastrointestinal diseases, including congenital gastrointestinal malformations that are prone to causing intussusception (such as Meckel diverticulum); 8. Congenital malformation or developmental disorder, genetic defect disease, severe malnutrition, malignant tumor or serious chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurological disease, Guillain Barre syndrome, etc.); 9. Existence of autoimmune diseases, immunodeficiency diseases (including but not limited to splenomegaly, functional splenomegaly, HIV infection); 10. Members who reside with the participants are in a state of immunodeficiency/immunosuppression or are currently/will soon receive immunosuppressive therapy, cytotoxic therapy, etc; 11. There are abnormalities in coagulation function (such as coagulation factor deficiency and platelet abnormalities); 12. Have received immunosuppressive therapy (prednisone = 2mg/kg/day, or its equivalent) or other immunomodulatory therapy, cytotoxic therapy for = 14 days since birth, or plan to receive such therapy during the study period; 13. Suffering from/having suffered from serious neurological disorders (epilepsy, seizures (excluding febrile seizures) or seizures) or mental illnesses, or having a related family history; 14. Use immunoglobulin or other blood products after birth, or plan to receive such treatment during the study period (except for hepatitis B immunoglobulin); 15. Have previously received other investigational drugs or vaccines, or plan to receive such drugs or vaccines during the study period; 16. Have received attenuated live vaccines within the past 14 days or subunit or inactivated vaccines, as well as other craft vaccines within the past 7 days; 17. Within the past 3 days, there has been an axillary temperature = 38.0 ?; 18. For those who have a fever on the day of planned vaccination with the experimental vaccine, the axillary temperature before vaccination should be above 37.0 ?; 19. Currently or planning to participate in clinical trials of other vaccines or drugs; 20. According to the researcher's judgment, participants have any other factors that are not suitable for participating in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive conversion rate of IgA antibodies against rotavirus of the anti epidemic vaccine type in serum 28 days after full immunization;Incidence of adverse events/reactions within 42 days after the first dose to the last dose of vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive rate of serum anti vaccine type rotavirus IgA antibodies 12 months after full immunization with the first dose, and incidence of adverse events/reactions within 42 days after GMC to the last;Within 14 days after each dose of vaccination on the 12th day after full immunization, the detoxification rate and duration of rotavirus vaccine strains in feces were measured in months;Within 14 days after each dose of vaccination, the incidence of rotavirus vaccine strain reassortment and atavism in feces; | — |
Countries
China
Contacts
Public ContactYeqing Tong
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed