CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 80 enrolled
Drug / intervention
V212biological
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/NCT01460719
NCT01460719Phase 1Completed
CompareCT.gov

A Phase I, Open-Label, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies Receiving Treatment With Anti-CD20 Monoclonal Antibodies

Merck Sharp & Dohme LLC·interventional·Posted Oct 27, 2011·Updated Mar 11, 2019

In Brief

A Phase 1 clinical trial evaluating V212 for Herpes Zoster. Completed, enrolled 80 participants.

Detailed Summary

An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving anti-CD20 monoclonal antibodies. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at \~28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the geometric mean fold rise in immune response in V212 recipients is \>1.0.

Study Details

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

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 27, 2011
Enrollment StartJan 24, 2012
Primary CompletionSep 25, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.7 years ago

Interventions

V212biological

V212 viral antigen for HZ