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Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01738074
Recruitment Status : Unknown
Verified November 2012 by Center for Disease Control and Prevention, Henan Province.
Recruitment status was:  Active, not recruiting
First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Randomized Double-blind Placebo Control Design Biological: trivalent rotavirus genetic reassortment vaccine Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10020 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : August 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

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

Primary Outcome Measures :
  1. Antibody titer differences in serum [ Time Frame: 4 weeks after full vaccination ]
  2. Incidence differences of rotavirus diarrhea [ Time Frame: 2 years after full vaccination. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 13 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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Responsible Party: Center for Disease Control and Prevention, Henan Province Identifier: NCT01738074    
Other Study ID Numbers: HNCDC-001
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012
Keywords provided by Center for Disease Control and Prevention, Henan Province:
trivalent genetic reassortment vaccine
Phase three clinical trials
Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs