A Lot-to-Lot Consistency Study to Evaluate Safety, Tolerability, and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Healthy Adults (V212-014)

August 11, 2015 updated by: Merck Sharp & Dohme LLC

A Phase III, Double-Blind, Lot-To-Lot Consistency Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults

The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety, tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Afebrile (<=100.4 °F [<=38.0 °C]) oral or equivalent on Day 1 before the first vaccination
  • Any underlying chronic illness that is not in stable condition
  • History of varicella, antibodies to VZV, or residence (for >=30 years) in a country with endemic VZV infection
  • Female participants of childbearing potential must have a negative pregnancy test. A female not of reproductive potential has reached natural menopause, or is 6-weeks postsurgical bilateral oophorectomy and/or hysterectomy or bilateral tubal ligation
  • Male, or female of childbearing potential who agrees to remain abstinent or use 2 acceptable methods of birth control from 2 weeks before enrollment to 6 months after the last study vaccination

Exclusion Criteria:

  • History of allergic reaction to any vaccine component, or an anaphylactic/anaphylactoid reaction to neomycin (not including contact dermatitis to neomycin)
  • Prior history of herpes zoster
  • History of receipt or expects to receive any varicella or zoster vaccine during the study period
  • Is pregnant or breastfeeding, or expects to conceive from 2 weeks before enrollment to 6 months after the last study vaccination
  • Has received a live virus vaccine or is scheduled to receive any live virus vaccine from 4 weeks before the first dose of study vaccination and throughout the study
  • Has received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days before to 7 days after any study vaccination
  • Received immunoglobulin or any blood products or is scheduled to receive them from 5 months before the first dose of study vaccination and throughout the study
  • Has participated in an investigational drug or vaccine study within 30 days before enrollment
  • Has any acute illness or significant underlying illness that may interfere with interpretation of the study
  • Receiving immunosuppressive therapy (including systemic corticosteroid doses exceeding physiological replacement doses within 14 days prior to the first vaccination), except topical, ophthalmic, or inhaled corticosteroids or intra-articular or soft-tissue injections of steroids
  • Has known or suspected immune dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: V212 Lot 1
Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
Biological: V212 Lot 1
Inactivated Varicella Zoster Virus vaccine
Experimental: V212 Lot 2
Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
Biological: V212 Lot 2
Inactivated Varicella Zoster Virus vaccine
Experimental: V212 Lot 3
Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
Biological: V212 Lot 3
Inactivated Varicella Zoster Virus vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean Titer of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers
Time Frame: 28 days postdose 4
28 days postdose 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with a Serious Adverse Experience
Time Frame: Up to 28 days postdose 4
Up to 28 days postdose 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V212-014
  • 2014-001030-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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