NCT01738074UnknownPhase 3
Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine
Center for Disease Control and Prevention, Henan Province0 sites10,020 target enrollmentStarted: August 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 10,020
- Primary Endpoint
- Antibody titer differences in serum
Study Overview
Brief Summary
Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 6 Weeks to 13 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •6 to 13 weeks aged healthy baby;
- •Guardian volunteer to participate in the study and sign informed consent;
- •have use thermometer as required and the ability to fill in the diary table;
- •Subjects guardian can abide by the requirements of clinical research scheme;
- •The past has not been vaccinated rotavirus vaccine;
- •Normal term eutocia, birth weight up to standard;
- •Axillary temperature is 37.0 ℃ or less.
Exclusion Criteria
- •With allergy, convulsion, epilepsy, encephalopathy and spirit history or the family history;
- •Be allergy to any ingredients in the vaccine;
- •Known immunology function damage or low person;
- •Immunosuppressant therapy Accepter;
- •Suffering from congenital malformation and developmental disorder;
- •Known or suspected also suffer from diseases including: digestive system disease, respiratory system disease, acute infection, mother or I have HIV infection, cardiovascular diseases, malignant tumor during treatment, skin disease;
- •Inoculation other vaccine within 7 days.
Outcomes
Primary Outcomes
Antibody titer differences in serum
Time Frame: 4 weeks after full vaccination
Incidence differences of rotavirus diarrhea
Time Frame: 2 years after full vaccination.
Secondary Outcomes
No secondary outcomes reported
Investigators
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