Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

Center for Disease Control and Prevention, Henan Province

Status and phase

Unknown

Phase 3

Conditions

Placebo Control Design

Randomized

Double-blind

Treatments

Biological: Placebo

Biological: trivalent rotavirus genetic reassortment vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT01738074

HNCDC-001

Details and patient eligibility

About

Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.

Enrollment

10,020 patients

Sex

All

Ages

6 to 13 weeks old

Volunteers

Accepts Healthy Volunteers

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.