Double-blind, Placebo Control Design, Randomized
Conditions
Keywords
rotavirus, trivalent genetic reassortment vaccine, Phase three clinical trials
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.
Interventions
BIOLOGICALtrivalent rotavirus genetic reassortment vaccine
BIOLOGICALPlacebo
Sponsors
Center for Disease Control and Prevention, Henan Province
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 13 Weeks
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody titer differences in serum | 4 weeks after full vaccination |
| Incidence differences of rotavirus diarrhea | 2 years after full vaccination. |
Outcome results
None listed