Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

NCT01738074 | Unknown Phase 3

• 1 other identifier: HNCDC-001
• Study Type: interventional
• Target: 10,020
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Randomized; Double-blind; Placebo Control Design

Keywords

rotavirus; trivalent genetic reassortment vaccine; Phase three clinical trials

Outcome Measures

Primary Outcomes (2)

• Antibody titer differences in serum

  4 weeks after full vaccination

• Incidence differences of rotavirus diarrhea

  2 years after full vaccination.

Study Arms (2)

trivalent rotavirus genetic reassortment vaccine

EXPERIMENTAL

2ml of rotavirus genetic reassortment vaccine by mouth every month for three month

Biological: trivalent rotavirus genetic reassortment vaccine

Placebo

PLACEBO COMPARATOR

2ml of placebo by mouth every month for three month

Biological: Placebo

Interventions

trivalent rotavirus genetic reassortment vaccine BIOLOGICAL

trivalent rotavirus genetic reassortment vaccine

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 6 Weeks - 13 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 30, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 30, 2012

Record last verified: 2012-11