Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine
Phase 3
- Conditions
- RandomizedDouble-blindPlacebo Control Design
- Registration Number
- NCT01738074
- Lead Sponsor
- Center for Disease Control and Prevention, Henan Province
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10020
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Antibody titer differences in serum 4 weeks after full vaccination Incidence differences of rotavirus diarrhea 2 years after full vaccination.
- Secondary Outcome Measures
Name Time Method