Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 002

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Meningitis

Clinical Trial Details

NCT number	NCT01661738
Study type	Interventional
Source	Hualan Biological Engineering, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	May 2006
Completion date	June 2006

View Details

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