Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Center for Disease Control and Prevention, Henan Province
ClinicalTrials.gov Identifier:
NCT01738074
First received: November 20, 2012
Last updated: November 28, 2012
Last verified: November 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
  • Incidence differences of rotavirus diarrhea [ Time Frame: 2 years after full vaccination. ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   6 Weeks to 13 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Center for Disease Control and Prevention, Henan Province
ClinicalTrials.gov Identifier: NCT01738074     History of Changes
Other Study ID Numbers: HNCDC-001
Study First Received: November 20, 2012
Last Updated: November 28, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 14, 2014