CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 354 enrolled
Drug / intervention
V212 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01527383
NCT01527383Phase 2Completed
CompareCT.gov

A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients With Autoimmune Disease

Merck Sharp & Dohme LLC·interventional·Posted Feb 7, 2012·Updated Jan 14, 2019

In Brief

A Phase 2 clinical trial evaluating V212 and Placebo for Herpes Zoster. Completed, enrolled 354 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2012
Enrollment StartFeb 21, 2012
Primary CompletionFeb 26, 2013
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 14.4 years ago

Interventions

V212biological

V212 viral antigen for HZ

Placebobiological

Placebo comparator to V212 vaccine