NCT01661738

Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 002

Phase II Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (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 II 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	Group ACYW135 Meningococcal Polysaccharide Vaccine	360 subjects were divided into three groups (120 subjects in each group), children (2\~6 years of age), early youth (7\~15 years of age) and adult (16\~30 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-05-01
• Completion: 2006-06-01
• First posted: 2012-08-09
• Last updated: 2012-08-09