Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

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

Study Overview

• Status: Unknown
• Conditions: Randomized; Double-blind; Placebo Control Design
• Intervention / Treatment: Biological: Placebo; Biological: trivalent rotavirus genetic reassortment vaccine

• Study Type: Interventional
• Enrollment (Actual): 10020
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trivalent rotavirus genetic reassortment vaccine; 2ml of rotavirus genetic reassortment vaccine by mouth every month for three month	Biological: trivalent rotavirus genetic reassortment vaccine
Placebo Comparator: Placebo; 2ml of placebo by mouth every month for three month	Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Antibody titer differences in serum	4 weeks after full vaccination
Incidence differences of rotavirus diarrhea	2 years after full vaccination.

Collaborators and Investigators

• Sponsor: Center for Disease Control and Prevention, Henan Province

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 28, 2012
• First Posted (Estimate): November 30, 2012

Study Record Updates

• Last Update Posted (Estimate): November 30, 2012
• Last Update Submitted That Met QC Criteria: November 28, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: rotavirus; trivalent genetic reassortment vaccine; Phase three clinical trials
• Other Study ID Numbers: HNCDC-001