Acute gastroenteritis
Conditions
Interventions
Experimental group 1:Experimental vaccine 1,Commercial scale batch 1
Experimental group 2 :Experimental vaccine 2,Commercial scale batch 2
Experimental group3 :Experimental vaccine 3,Commercial scale batch 3
Experimental group 4 :Experimental vaccine 4, Batch of pilot plant
Sponsors
Hebei Provincial Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Enrollment age is 6-12 weeks old (2500g <= birth weight , 37 weeks <= gestational age <= 42 weeks); 2) The guardian shall provide informed consent and sign an informed consent form, be able to comply with the requirements of the trial protocol, and provide legal identification materials of the subject and guardian; 3) Not receiving non live vaccines within 7 days and not receiving live vaccines within 14 days; 4) On the day of enrollment, the body temperature was <= 37.0 ? (axillary temperature).
Exclusion criteria
Exclusion criteria: First dose exclusion criteria: 1) Babies born during abnormal labor processes such as difficult delivery, instrumental assisted delivery, and anterograde cesarean section (excluding voluntary cesarean section) with severe complications such as intracranial hemorrhage, gastrointestinal bleeding, and respiratory dysfunction, or with a history of asphyxia and neurological damage, currently suffering from pathological jaundice and perianal abscess; 2) Previously received any rotavirus vaccine; 3) Have a history of congenital gastrointestinal diseases, a history of rotavirus gastroenteritis, chronic diarrhea, gastrointestinal dysplasia, or abdominal surgery; 4) Individuals who have suffered from gastrointestinal diseases within the past week and are deemed unsuitable for enrollment by the researchers; 5) Having a history of intussusception, including congenital gastrointestinal abnormalities that can easily cause intussusception (such as Meckel's diverticulum); 6) Has a history of severe allergies to any medication, food, or vaccination, such as urticaria, allergic shock, allergic laryngeal edema, allergic dyspnea, severe eczema, allergic purpura, and thrombocytopenic purpura; 7) People suffering from infectious diseases, such as tuberculosis, viral hepatitis and/or human immunodeficiency virus HIV infection; 8) Suffering from serious congenital malformations, severe developmental disorders, severe genetic diseases (such as severe thalassemia), severe malnutrition, etc. that may interfere with the progress or completion of the study; 9) Has been diagnosed with congenital or acquired immunodeficiency, or has received treatment with immunosuppressants and other immunomodulatory drugs, such as systemic glucocorticoid therapy for more than 2 weeks in a month prior to vaccination, such as prednisone or similar drugs>5mg/day (note: local and inhaled/nebulized steroids can be used); 10) Have a history of convulsions, epilepsy, encephalopathy (including but not limited to congenital brain hypoplasia, brain trauma, brain tumors, cerebral hemorrhage, cerebral infarction, etc.), and a history of mental illness or family history; 11) Suffering from acute illness or being in an acute phase of chronic illness within 3 days; 12) Previously, high fever (axillary temperature >= 39.5 ° C) occurred 48 hours after vaccination, with or without seizures; Encephalopathy or epilepsy within 7 days after vaccination; 13) Have received blood or blood related products or immunoglobulin (hepatitis B immunoglobulin is acceptable); 14) The subject's guardian plans to move before the end of the study or leave the local area for a long time during the scheduled visit period; 15) The researchers believe that the subjects may have other conditions that could interfere with the evaluation of the research objectives. Exclusion criteria for dose 2/3: 1) Newly discovered or occurring cases that meet the first exclusion criteria prior to subsequent dose vaccination; 2) Acute allergic reactions of grade 3 or higher related to vaccination after the previous dose of vaccine administration; 3) Other serious adverse events: decide to terminate the trial vaccine administration based on their treatment needs; 4) Any other reasons for terminating the trial vaccine administration as assessed by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMC and seropositivity conversion rate of IgA antibodies against various rotavirus serotypes and total IgA antibodies at 28 days post-full-course vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| GMI of IgA antibodies against various rotavirus serotypes and total IgA antibodies at 28 days post-full-course vaccination; | — |
Countries
China
Contacts
Public ContactZhiwei Wu
Hebei Provincial Center for Disease Prevention and Control
Outcome results
None listed