This trial is active, not recruiting.

Conditions randomized, double-blind, placebo control design
Treatments trivalent rotavirus genetic reassortment vaccine, placebo
Phase phase 3
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
2ml of rotavirus genetic reassortment vaccine by mouth every month for three month
trivalent rotavirus genetic reassortment vaccine
(Placebo Comparator)
2ml of placebo by mouth every month for three month

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.

Eligibility Criteria

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.

Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Center for Disease Control and Prevention, Henan Province.