Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01738074
• Other study ID #: HNCDC-001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 20, 2012
• Last updated: November 28, 2012
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2012
• Source: Center for Disease Control and Prevention, Henan Province
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10020
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 13 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Double-blind
• Placebo Control Design
• Randomized

Intervention

Biological:
• trivalent rotavirus genetic reassortment vaccine

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Center for Disease Control and Prevention, Henan Province

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody titer differences in serum		4 weeks after full vaccination	Yes
Primary	Incidence differences of rotavirus diarrhea		2 years after full vaccination.	Yes