A Phase Ⅲ Clinical Trial for Efficacy, Immunogenicity, Safety and Immune Persistence of Oral Recombinant Helicobacter Pylori Vaccine in Chinese Children Aged From 6-15 Years Old.

NCT02302170 Phase 3 COMPLETED

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.

Details

Lead sponsor	Jiangsu Province Centers for Disease Control and Prevention
Phase	Phase 3
Status	COMPLETED
Enrolment	4464
Start date	2004-12
Completion	2008-09

Conditions

• H. Pylori Infection

Interventions

• H. pylori vaccine
• placebo

Primary outcomes

• The occurrence of Helicobacter pylori infection in participants one year after three-dose vaccinations. — one year after the third dose

Countries

China