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Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

NCT01505647 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2017-04-12

Study results available
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Summary

This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process \[ZOSTAVAX™ (AMP)\] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.

Conditions

  • Herpes Zoster
  • Shingles

Interventions

BIOLOGICAL

Zoster Vaccine, Live (AMP)

One approximately 0.65-mL injection subcutaneously on Day 1

BIOLOGICAL

Zoster Vaccine, Live

One approximately 0.65-mL injection subcutaneously on Day 1

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-07-31
Completion
2012-11-30

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01505647 on ClinicalTrials.gov