A Phase Ⅲ Clinical Trial With Oral Recombinant Helicobacter Pylori Vaccine in Chinese Children (NCT02302170) | Clinical Trial Compass
CompletedPhase 3
A Phase Ⅲ Clinical Trial With Oral Recombinant Helicobacter Pylori Vaccine in Chinese Children
China4,464 participantsStarted 2004-12
Plain-language 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 infection is a risk factor for the development of gastritis, peptic ulcer, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer.
The phaseⅠand Ⅱclinical trial of oral recombinant Helicobacter pylori vaccine had completed in Jiangsu Province in China. The data from phaseⅠand Ⅱclinical trial suggested that the oral recombinant Helicobacter pylori vaccine had a clinically acceptable safety and good immunogenicity for health adults and children. To further explore the safety and immunogenicity profile of this vaccine, a phase Ⅲ clinical trial was conducted.
Who can participate
Age range
6 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
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 interfer…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The occurrence of Helicobacter pylori infection in participants one year after three-dose vaccinations.
Timeframe: one year after the third dose
Trial details
NCT IDNCT02302170
SponsorJiangsu Province Centers for Disease Control and Prevention