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Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine

Hepatitis B Clinical Trial

Official title:
An Open Label Multicentric Study to Evaluate the Immunogenicity and Safety of Indigenously Developed DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine (Shan 5) in Indian Infants.

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00617812
Study type Interventional
Source Shantha Biotechnics Limited
Contact
Status Completed
Phase Phase 4
Start date March 2008
Completion date May 2009
View Details
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