Status:
COMPLETED
A Phase Ⅲ Clinical Trial With Oral Recombinant Helicobacter Pylori Vaccine in Chinese Children
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
National Institutes for Food and Drug Control, China
Kangwei Biological Technology
Conditions:
H. Pylori Infection
Eligibility:
All Genders
6-15 years
Phase:
PHASE3
Brief Summary
Helicobacter pylori (H. pylori) is a Gram-negative, microaerophilic bacterium that persistently colonizes the human stomach; more than half the human population is infected worldwide. H. pylori infect...
Detailed Description
Helicobacter pylori (H. pylori) is a Gram-negative, microaerophilic bacterium that persistently colonizes the human stomach; more than half the human population is infected worldwide. H. pylori infect...
Eligibility Criteria
Inclusion
- Healthy children aged from 6-15 years old as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature \<=37.0°C on axillary setting before vaccination
Exclusion
- Exclusion criteria for the first dose
- Subject who has a medical history of stomach illness
- Positive in either serology ELISA test for Helicobacter pylori diagnose kit or 13C urea breath test
- Subject who has suffered from heart, liver, and kidney disease
- Subject who has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine (for example: mannitol)
- Subject who is suffering from thrombocytopenia or other coagulation disorder
- Subject who has a diminished function of the immune system or autoimmune disease
- Subject who is suffering from congenital deformities, developmental disorders or serious chronic diseases
- Family history of seizures or progressive neurological disease
- Severe malnutrition or dysgenopathy, major congenital defects or serious chronic illness, including perinatal brain damage
- Any acute infections in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6 month
- Any prior administration of other research medicines in last 1 month
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- Exclusion criteria for the second and third dose Subjects will not be eligible for the second or third dose if any of following happened after first dose
- Subject who had allergic reaction to the last dose
- Any situation meet the exclusion criteria occurred after the last dose
- Subject who had any serious adverse events related to the vaccination
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
4464 Patients enrolled
Trial Details
Trial ID
NCT02302170
Start Date
December 1 2004
End Date
September 1 2008
Last Update
November 26 2014
Active Locations (1)
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1
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009