A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)

NCT01527383 PHASE2 COMPLETED Results posted

This is a study to evaluate the safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including participants with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and other similar diseases. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at approximately 28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	PHASE2
Status	COMPLETED
Enrolment	354
Start date	Tue Feb 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Feb 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Herpes Zoster

Interventions

• V212
• Placebo