Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old (NCT06350058) | Clinical Trial Compass
UnknownPhase 1
Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old
China375 participantsStarted 2021-08-03
Plain-language summary
The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.
Who can participate
Age range6 Weeks – 49 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects aged 6-12 weeks, 1-5 years old, 18-49 years old, able to provide legal identification;
* The subjects or the legal guardians of the subject have the ability to understand the research procedure, agree to participate in the study (or the legal guardian of the subject agrees to the child's participation in the study), and signs an informed consent form;
* The subjects or their legals guardian are able to participate in all planned follow-up visits;
* On the day of enrollment, the axillary body temperature was ≤ 37.0 ℃;
* Standards for certain groups of people:
Subjects aged ≥ 1 year: Laboratory test indicators (as specified in the protocol) within the normal range, or those with abnormalities but no clinical significance (evaluated by clinical doctors); Female participants of childbearing age: non pregnant, non lactating, and agreed to take effective contraceptive measures within 8 months after participating in the study.
Exclusion Criteria:
* Previously received any rotavirus vaccine;
* Previous history of acute gastroenteritis caused by rotavirus;
* Have a history of intussusception, congenital abnormalities in the digestive system, chronic diarrhea, and other diseases in the past;
* Have any history of severe allergies to vaccines or drugs in the past, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthurs reaction);
* Suffering from serious congenital malf…
What they're measuring
1
Incidence rate of AE
Timeframe: 0~30 day after vaccination
2
Incidence rate of SAE
Timeframe: From the first dose of vaccination to the 6 months after achieving the entire immunization process