Status:
RECRUITING
Phase II Clinical Trial of the Inactivated Rotavirus Vaccine
Lead Sponsor:
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Henan Center for Disease Control and Prevention
Conditions:
Rotavirus Infections
Diarrhea
Eligibility:
All Genders
2-71 years
Phase:
PHASE2
Brief Summary
This study is a randomized, double-blinded, placebo-controlled phase 2 clinical trial to evaluate the immunogenicity and safety of Inactivated Rotavirus Vaccine (IRV) in children (aged 2-71 months). P...
Detailed Description
This is a randomized, double-blinded, placebo-controlled phase 2 clinical trial to evaluate immunogenicity and safety of IRV performed in 600 subjects (aged 2-71 months). Then, 300 toddlers (aged 7-71...
Eligibility Criteria
Inclusion
- Age Requirement: Infants and toddlers aged 2 to 71 months at the time of enrollment.
- Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
- No Previous Rotavirus Vaccination: Infants and toddlers enrolled in the study should not have received any rotavirus vaccines before enrollment.
Exclusion
- First Dose Exclusion Criteria
- Subjects meeting any of the following exclusion criteria will be not eligible for enrollment:
- Temperature Requirement: Axillary body temperature prior to vaccination is up to 37.3°C or more.
- Allergic History: Subjects have a history of allergies to any component of the investigational vaccine (e.g., aluminum hydroxide), any history of vaccine allergies, suspected allergies, or any other severe adverse reactions.
- Vaccine History: Subjects received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines or COVID-19 vaccines within 14 days (including the 14th day) prior to vaccination.
- Health Conditions: Subjects have known congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions.
- Immune-Related Diseases: Subjects have compromised primary or secondary immune function, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune diseases.
- Gastrointestinal Conditions: Subjects have a history of intussusception or chronic gastrointestinal diseases.
- Neurological and Mental Health: Subjects have a history of seizures, convulsions, cerebral palsy, epilepsy, mental illness, or a family history of such conditions.
- Acute Illness: Subjects have experienced acute illnesses (e.g., fever) within 3 days prior to vaccination with the investigational vaccine.
- Immune Therapy: Subjects have received immune-enhancing or immune-suppressing therapy within the last 3 months (continuous oral or intravenous administration for more than 14 days) prior to vaccination.
- Coagulation Abnormalities: Subjects have a history of coagulation disorders (e.g., coagulation factor deficiency, coagulation disorders).
- Organ Removal History: Subjects have a history of organ removal (e.g., thyroid, pancreas, liver, spleen) or have asplenia syndrome.
- Participation in Other Clinical Studies: Subjects are currently or have plans to participate in other clinical studies before enrollment.
- Special Conditions for Children Aged 24 Months and Below: For such children, additional exclusion criteria include difficult birth, resuscitation after suffocation, a history of neurological damage, premature birth (delivery before the 37th week of gestation), and low birth weight (less than 2500 grams).
- Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study.
- Contraindication of the second and third doses of vaccine
- Severe Adverse Reactions: Subjects experienced severe adverse reactions after receiving the previous vaccine dose.
- No Longer Meeting Inclusion Criteria or Meeting First Dose
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 17 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06080906
Start Date
October 20 2023
End Date
June 17 2025
Last Update
January 3 2024
Active Locations (1)
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1
Tongxu Center for Disease Prevention and Control
Kaifeng, Henan, China