A Study to Evaluate the Immunogenicity, Safety, and Toler... | NCT01626794

Studies
A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)

NCT01626794

Sponsor

Merck Sharp & Dohme LLC

Status

Withdrawn

Last Update Posted

Jan 27, 2015Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Varicella

Interventions

VARIVAX™ VEP
VARIVAX™ 2007 Process
M-M-R™ II

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Oct 2015Estimated

Completion Date

Oct 2015Estimated

First Submitted Date

Jun 8, 2012

First Submission Date that Met QC Criteria

Jun 20, 2012

First Posted Date

Jun 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2015

Last Update Posted Date

Jan 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response rate at 6 weeks after vaccination 1.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VARIVAX™ VEP	Experimental		Biological: VARIVAX™ VEP Biological: M-M-R™ II
VARIVAX™ 2007 Process	Active Comparator		Biological: VARIVAX™ 2007 Process Biological: M-M-R™ II

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VARIVAX™ VEP	Biological	Two 0.5 mL subcutaneous doses administered on Days 1 and 91	VARIVAX™ VEP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL		Six weeks (43 days) after vaccination 1

Secondary Outcomes

Measure	Description	Time Frame
Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)		Days 1 to 42 after each vaccination
Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms		Days 1 to 42 after each vaccination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

negative clinical history of measles, mumps, rubella, varicella, and zoster

Exclusion Criteria:

received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to require them throughout the study
history of allergy or anaphylactoid reaction to neomycin, gelatin, sorbital, egg proteins, chicken proteins, or any components of M-M-R™ II or VARIVAX™
received salicylates within 14 days prior to study vaccination
exposed to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to study vaccination
received any non-live vaccine within 14 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination
received any live vaccine within 30 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination
received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to any study vaccination
fever illness (≥102.2°F [39.0°C]) within 72 hours prior to study vaccination
born to a human immunodeficiency virus (HIV)-infected mother
participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

23 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases