NCT00617812

Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Shantha Biotechnics Limited · Industry
• Sex: All
• Age: 6 Weeks – 8 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Haemophilus Influenzae Type B

Interventions

Type	Name	Description
BIOLOGICAL	Shan5	Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2008-02-18
• Last updated: 2009-06-25

Locations

4 sites across 1 country: India