rotavirus gastroenteritis
Conditions
Interventions
6-12 weeks old middle dose (3 dose,1 month interval) group:All subjects will receive one dose of Recombinant Trivalent Subunit Rotavirus Vaccine or placebo at Months 0, 1 and 2.
6-12 weeks old high dose (3 dose,1 month interval) group:All subjects will receive one dose of Recombinant Trivalent Subunit Rotavirus Vaccine or placebo at Months 0, 1 and 2.
6-12 weeks old low dose (3 dose,2 month interval) group:All subjects will receive one dose of Recombinant Trivalent Subunit Rotavirus Vaccine or placebo at Months 0, 2 and 4.
6-12 weeks old middle dose (3 dose, 2 month interval) group:All subjects will receive one dose of Recombinant Trivalent Subunit Rotavirus Vaccine or placebo at Months 0, 2 and 4.
6-12 weeks old high dose (3 dose,2 month interval) group:All subjects will receive one dose of Recombinant Trivalent Subunit Rotavirus Vaccine or placebo at Months 0, 2 and 4.
Sponsors
Henan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
0.1 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. Healthy infants and young children aged 6-12 weeks and 7-71 months old; 2. The legal guardian or the entrusted person agrees to participate in the ward and signs the informed consent form, and can comply with the requirements of the clinical trial protocol.
Exclusion criteria
Exclusion criteria: First dose exclusion criteria: 1. Axillary body temperature >37.0? before vaccination; 2. Have received any rotavirus vaccine in the past; 3. Those with a history of intussusception or a history of intussusception or any chronic gastrointestinal disease, including congenital malformations of the gastrointestinal tract that are likely to cause intussusception (such as Meckel's diverticulum); 4. Congenital malformations, developmental disorders, genetic defects, severe malnutrition, etc.; 5. Those under the age of 2 with a history of dystocia, suffocation rescue, and nervous system damage; 6. Premature birth under the age of 2 (delivery before the 37th week of pregnancy), low birth weight (birth weight 39.0?) or acute onset of chronic diseases within 3 days before receiving the study vaccine; 10. Receive immune enhancement (including oral or intravenous immune globulin, but hepatitis B immune globulin is acceptable) or immunosuppressive therapy (continuous oral or intravenous infusion for more than 14 days) within 3 months; 11. Have been vaccinated with live attenuated vaccines within 14 days, and have received other vaccines within 7 days; 12. Suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases; 13. History of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease); 14. Primary and secondary immunocompromised (history of thyroid, pancreas, liver, splenectomy, or treatment due to thyroid disease within the past 12 months); 15. Are currently or plan to participate in other clinical studies in the near future; 16. According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial. Subsequent injection exclusion criteria: 17. Those with severe allergic reaction after the previous dose of vaccine; 18. Serious adverse reactions that are causally related to the previous dose of vaccination; 19. After the first dose of vaccination, those newly discovered or newly occurred who do not meet the inclusion criteria or meet the first dose exclusion criteria will be determined by the investigator whether to continue participating in the study; 20. Other reasons for exclusion considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;anti-Rotavirus IgG seroresponses, Geometric Mean Titer (GMT);anti-Rotavirus IgA seroresponses, Geometric Mean Titer (GMT);anti-Rotavirus neutralising seroresponses, GMT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse event;anti-Rotavirus IgG seroresponses, Geometric Mean Titer (GMT);anti-Rotavirus IgA seroresponses, Geometric Mean Titer (GMT);anti-Rotavirus neutralising seroresponses, GMT; | — |
Countries
China
Contacts
Public ContactWang Yanxia
Henan Provincial Center for Disease Control and Prevention
Outcome results
None listed