NCT01661725

Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001

Phase I Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (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 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 I clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine. The safety end points were the presence of any systemic, local and adverse reaction.

Conditions

• Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Group ACYW135 Meningococcal Polysaccharide Vaccine	60 subjects were divided into three groups (20 subjects 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

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-04-01
• Completion: 2006-05-01
• First posted: 2012-08-09
• Last updated: 2012-08-09