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Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Center for Disease Control and Prevention, Henan Province.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01738074
First Posted: November 30, 2012
Last Update Posted: November 30, 2012
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.
Information provided by (Responsible Party):
Center for Disease Control and Prevention, Henan Province
  Purpose
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 Intervention Phase
Randomized Double-blind Placebo Control Design Biological: trivalent rotavirus genetic reassortment vaccine Biological: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention

Further study details as provided by Center for Disease Control and Prevention, Henan Province:

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

Enrollment: 10020
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Center for Disease Control and Prevention, Henan Province
ClinicalTrials.gov Identifier: NCT01738074     History of Changes
Other Study ID Numbers: HNCDC-001
First Submitted: November 20, 2012
First Posted: November 30, 2012
Last Update Posted: November 30, 2012
Last Verified: November 2012

Keywords provided by Center for Disease Control and Prevention, Henan Province:
rotavirus
trivalent genetic reassortment vaccine
Phase three clinical trials

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs