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Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

NCT ID: NCT01738074

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

10020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-12-31

Brief Summary

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Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.

Detailed Description

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Conditions

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Randomized Double-blind Placebo Control Design

Keywords

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rotavirus trivalent genetic reassortment vaccine Phase three clinical trials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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trivalent rotavirus genetic reassortment vaccine

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

Group Type EXPERIMENTAL

trivalent rotavirus genetic reassortment vaccine

Intervention Type BIOLOGICAL

Placebo

2ml of placebo by mouth every month for three month

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Interventions

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trivalent rotavirus genetic reassortment vaccine

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

13 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Disease Control and Prevention, Henan Province

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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HNCDC-001

Identifier Type: -

Identifier Source: org_study_id