Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A

NCT00920218 ↗

Phase 2 Completed 121 enrolled GlaxoSmithKline

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.

Timeline

Start: 2009-07-14
Primary completion: 2011-04-26
Completion: 2012-03-21

Outcome

Met primary endpoint

registry analysis (superiority test); GSK 1437173A F1 Group; p <0.0001; Fold increase over Control 32.31 (76.16% CI 20.65 to 50.54); Dunnett for multiple comparisons NCT00920218 ↗

registry analysis (superiority test); GSK 1437173A F1 Group; p <0.0001; Fold increase over Control 74.41 (76.16% CI 33.12 to 167.17); Dunnett for multiple comparisons NCT00920218 ↗

Publications

Stadtmauer EA, Sullivan KM, Marty FM, Dadwal SS, Papanicolaou GA, Shea TC, Mossad SB, Andreadis C, Young JA, Buadi FK, El Idrissi M, Heineman TC, Berkowitz EM. A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood. 2014 Nov 6;124(19):2921-9. doi: 10.1182/blood-2014-04-573048. Epub 2014 Sep 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Shingrix	Vaccine	50 ug	Intramuscular