Back to results

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

Primary Purpose

Varicella

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

VARIVAX™ VEP

VARIVAX™ 2007 Process

M-M-R™ II

About this trial

This is an interventional prevention trial for Varicella

Eligibility Criteria

12 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VARIVAX™ VEP

VARIVAX™ 2007 Process

Arm Description

Outcomes

Primary Outcome Measures

Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL

Secondary Outcome Measures

Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)

Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms

Percent of participants with injection-site reactions

Full Information

NCT ID

NCT01626794

First Posted

June 8, 2012

Last Updated

January 26, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01626794

Brief Title

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

Official Title

A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX Made With the Varicella Enhanced Process (VEP)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Withdrawn

Study Start Date

July 2014 (undefined)

Primary Completion Date

October 2015 (Anticipated)

Study Completion Date

October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Varicella

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VARIVAX™ VEP

Arm Type

Experimental

Arm Title

VARIVAX™ 2007 Process

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

VARIVAX™ VEP

Intervention Description

Two 0.5 mL subcutaneous doses administered on Days 1 and 91

Intervention Type

Biological

Intervention Name(s)

VARIVAX™ 2007 Process

Intervention Description

Two 0.5 mL subcutaneous doses administered on Days 1 and 91

Intervention Type

Biological

Intervention Name(s)

M-M-R™ II

Intervention Description

Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process

Primary Outcome Measure Information:

Title

Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL

Time Frame

Six weeks (43 days) after vaccination 1

Secondary Outcome Measure Information:

Title

Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)

Time Frame

Days 1 to 42 after each vaccination

Title

Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms

Time Frame

Days 1 to 42 after each vaccination

Title

Percent of participants with injection-site reactions

Time Frame

Days 1 to 5 after each vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

23 Months

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs