Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine
This trial is active, not recruiting.
|Conditions||randomized, double-blind, placebo control design|
|Treatments||trivalent rotavirus genetic reassortment vaccine, placebo|
|Sponsor||Center for Disease Control and Prevention, Henan Province|
|Start date||August 2012|
|End date||June 2014|
|Trial size||10020 participants|
|Trial identifier||NCT01738074, HNCDC-001|
Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, investigator)|
2ml of rotavirus genetic reassortment vaccine by mouth every month for three month
2ml of placebo by mouth every month for three month
Antibody titer differences in serum
time frame: 4 weeks after full vaccination
Incidence differences of rotavirus diarrhea
time frame: 2 years after full vaccination.
Male or female participants from 6 weeks up to 13 weeks old.
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.
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