A Clinical Study Comparing Safety and Immunogenicity of bOPV of Bilthoven Biologicals

Phase 3 Completed 1120 enrolled Bilthoven Biologicals Serum Institute of India Pvt. Ltd. · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. This study will also assess lot-to-lot consistency among three lots of BBio bOPV.

Timeline

Start: 2016-06-08
Primary completion: 2018-02-14
Completion: 2018-02-14

Publications

Background Zaman K, Kingma R, Yunus M, van Straaten I, Mekkes D, Bouwstra X, Gunale B, Kulkarni PS. Safety, immunogenicity and lot-to-lot consistency of a new Bivalent Oral Polio Vaccine (bOPV) in healthy Infants: Results of a Phase III, observer blind, randomized, controlled clinical study. Vaccine. 2019 Jul 18;37(31):4275-4280. doi: 10.1016/j.vaccine.2019.06.048. Epub 2019 Jun 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BBio bOPV	Vaccine	0.1 ml	Oral
Comparator	bOPV	Vaccine	0.1 ml	Oral

Indications

No indication recorded.