Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

Phase 3

• Conditions: Randomized; Double-blind; Placebo Control Design
• Interventions: Biological: trivalent rotavirus genetic reassortment vaccine; Biological: Placebo

• 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

Study Timeline

• Study Start: 2012-08
• Status Verified: 2012-11
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-28
• Last Update Submitted: 2012-11-28
• Study First Posted: 2012-11-30
• Last Update Posted: 2012-11-30
• Primary Completion: 2014-06
• Study Completion: 2014-12

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

Arm && Interventions

Group	Intervention	Description
trivalent rotavirus genetic reassortment vaccine	trivalent rotavirus genetic reassortment vaccine	2ml of rotavirus genetic reassortment vaccine by mouth every month for three month
Placebo	Placebo	2ml of placebo by mouth every month for three month

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.