Immunogenicity of Monovalent Type 2 Oral Poliovirus Vaccine

Phase 4 Completed 760 enrolled Centers for Disease Control and Prevention International Centre for Diarrhoeal Disease Research, Bangladesh · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

This is an open-label phase IV, randomized controlled trial of mOPV2 alone and mOPV2 along with IPV. This trial will assess the impact on type 2 immunogenicity by reducing the interval between mOPV2 doses. The trial will also evaluate any difference in immunogenicity when the first dose of mOPV2, in a two dose schedule with a four week interval, is administered simultaneously with IPV.

Timeline

Start: 2015-12
Primary completion: 2016-02
Completion: 2016-02

Publications

Zaman K, Estivariz CF, Morales M, Yunus M, Snider CJ, Gary HE Jr, Weldon WC, Oberste MS, Wassilak SG, Pallansch MA, Anand A. Immunogenicity of type 2 monovalent oral and inactivated poliovirus vaccines for type 2 poliovirus outbreak response: an open-label, randomised controlled trial. Lancet Infect Dis. 2018 Jun;18(6):657-665. doi: 10.1016/S1473-3099(18)30113-0. Epub 2018 Mar 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Monovalent Oral Polio Vaccine Type 2 (mOPV2)	Vaccine	0.1 ml	Oral
Comparator	inactivated polio vaccine	Vaccine	0.5 ml	Intramuscular

Immunogenicity of Monovalent Type 2 Oral Poliovirus Vaccine

Summary

Timeline

Publications

Drugs

Indications