NCT01661751

Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 003

Phase III Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Hualan Biological Engineering, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

The clinical trial was designed to evaluate the safety and immunogenicity against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.

Detailed description

Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase III clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine to evaluate the safety and immunogenicity of the experimental vaccine. The safety end points were the presence of any systemic, local and adverse reaction. Evaluation indicators of immunogenicity were bacteriocin levels of groups A, C, Y and W135 respectively in the serum after the whole vaccination.

Conditions

• Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	ACYW135 Meningococcal Polysaccharide Vaccine	600 subjects were divided into three groups (200 subjects in each group), adult (16\~30 years of age), early youth (7\~15 years of age) and children (2\~6 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
BIOLOGICAL	A+C Meningococcal Polysaccharide Vaccine	300 subjects were divided into three groups (100 subjects in each group), adult (16\~30 years of age), early youth (7\~15 years of age) and children (2\~6 years of age) to receive Group AC Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-05-01
• Completion: 2006-08-01
• First posted: 2012-08-09
• Last updated: 2012-08-09