rotavirus gastroenteritis
Conditions
Interventions
18-49 years old low dose group:All subjects will receive one dose of Recombinant Trivalent Subunit Rotavirus Vaccine or placebo at Months 0, 1 and 2.
18-49 years old middle dose group: All subjects will receive one dose of Recombinant Trivalent Subunit Rotavirus Vaccine or placebo at Months 0, 1 and 2.
18-49 years old high dose group: All subjects will receive one dose of Recombinant Trivalent Subunit Rotavirus Vaccine or placebo at Months 0, 1 and 2.
6-17 years old low dose group: All subjects will receive one dose of Recombinant Trivalent Subunit Rotavirus Vaccine or placebo at Months 0, 1 and 2.
6-17 years old middle dose group: All subjects will receive one dose of Recombinant Trivalent Subunit Rotavirus Vaccine or placebo at Months 0, 1 and 2.
6-17 years old high dose 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 middle dose (3 dose,1 month interval) group:All subjects will receive one dose of Recombinant Trivalent
Sponsors
Henan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
0.1 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Healthy people aged 1.6-12 weeks, 7 months-49 years old; 2. I voluntarily and/or the legal guardian or the entrusted person agrees to the ward to participate and sign the informed consent, 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. 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); 3. Congenital malformations, developmental disorders, genetic defects, severe malnutrition, etc.; 4. Those with a history of convulsions, epilepsy, convulsions, cerebral palsy, and a history of mental illness or family history; 5. Those who have a history of severe allergy to vaccination, or are allergic to any component of the research vaccine; 6. Various acute diseases (such as fever>39.0?) or acute onset of chronic diseases within 3 days before receiving the study vaccine; 7. 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; 8. Have been vaccinated with live attenuated vaccines within 14 days, and have received other vaccines within 7 days; 9. Suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases; 10. History of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease); 11. Primary and secondary immunocompromised (history of thyroid, pancreas, liver, splenectomy, or treatment due to thyroid disease within the past 12 months); 12. Currently or planning to participate in other clinical studies; 13. According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial. In addition to the general exclusion criteria, specific populations should follow the following exclusion criteria: 14. Women of childbearing age who are pregnant (positive urine pregnancy test), are breastfeeding, or have a pregnancy plan during the study; 15. Adults aged 18-49 with hypertension that cannot be controlled by drugs (on-site measurement: systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg); 16. Those aged 6-49 with clinically significant abnormalities in blood biochemistry, blood routine, and urine routine before vaccination; 17. Children aged 71 months and under have previously received any rotavirus vaccine; 18. Infants and young children under the age of 2 with a history of dystocia, suffocation rescue, and nervous system damage; 19. Premature birth (delivery before the 37th week of pregnancy) and low birth weight (birth weight <2500g) for infants and young children under the age of 2. Subsequent injection exclusion criteria: 20. Those with severe allergic reaction after the previous dose of vaccine; 21. Serious adverse reactions that are causally related to the previous dose of vaccination; 22. 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; 23. Other reasons for exclusion considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Blood chemistry;Blood routine;Urine routine;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;anti-Rotavirus IgG seroresponses, Geometric Mean Titer (GMT);anti-Rotavirus IgA seroresponses, Geometric Mean Titer (GMT);anti-Rotavirus neutralising seroresponses, GMT;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