Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

NCT01738074 Phase 3 UNKNOWN

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

Details

Lead sponsor	Center for Disease Control and Prevention, Henan Province
Phase	Phase 3
Status	UNKNOWN
Enrolment	10020
Start date	2012-08
Completion	2014-12

Conditions

• Randomized
• Double-blind
• Placebo Control Design

Interventions

• trivalent rotavirus genetic reassortment vaccine
• Placebo

Primary outcomes

• Antibody titer differences in serum — 4 weeks after full vaccination
• Incidence differences of rotavirus diarrhea — 2 years after full vaccination.