drugset

drugset / Trial / NCT02094586

A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

NCT02094586 ↗

Phase 3 Completed 3146 enrolled Bavarian Nordic Emergent BioSolutions · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.

Timeline

Start: 2014-05
Primary completion: 2015-02
Completion: 2015-06

Outcome

Met primary endpoint

registry analysis (equivalence test); PXVX0200 Lot A; Geometric Mean Ratio 0.92 (95% CI 0.78 to 1.08) NCT02094586 ↗

registry analysis (equivalence test); PXVX0200 Lot B; Geometric Mean Ratio 1.02 (95% CI 0.87 to 1.20) NCT02094586 ↗

registry analysis (equivalence test); PXVX0200 Lot A; Geometric Mean Ratio 0.94 (95% CI 0.80 to 1.10) NCT02094586 ↗

Publications

Results McCarty JM, Lock MD, Hunt KM, Simon JK, Gurwith M. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. Vaccine. 2018 Feb 1;36(6):833-840. doi: 10.1016/j.vaccine.2017.12.062. Epub 2018 Jan 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PXVX0200	Vaccine	—	Oral

Indications