NCT00877357

Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine

Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Shantha Biotechnics Limited · Industry
• Sex: All
• Age: 6 Weeks – 8 Weeks
• Healthy volunteers: Accepted

Summary

A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Shan 5	Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-12-01
• Completion: 2013-02-01
• First posted: 2009-04-07
• Last updated: 2009-05-06

Locations

1 site across 1 country: India