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Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)

Primary Purpose

Varicella

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VARIVAX® PE34 Process
VARIVAX® 2016 Commercial Process
M-M-R II®
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

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 for varicella, herpes zoster, measles, mumps, and rubella

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 receive them during the course of the study
  • History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX® or M-M-R II®
  • Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems
  • Received salicylates within 14 days prior to study vaccination
  • Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination
  • Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination
  • History of seizure disorder, including febrile seizure
  • Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination
  • History of thrombocytopenia
  • Born to a human immunodeficiency virus (HIV)-infected mother
  • Has a diagnosis of active untreated tuberculosis
  • Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.

Sites / Locations

  • Alabama Clinical Therapeutics ( Site 0018)
  • Children's Clinic of Jonesboro, PA ( Site 0030)
  • Southland Clinical Research Center ( Site 0017)
  • Premier Health Research Center, LLC ( Site 0044)
  • California Research Foundation ( Site 0003)
  • IMMUNOe Research Centers ( Site 0046)
  • Children's Research at Altamonte Pediatric Associates ( Site 0040)
  • University of South Florida ( Site 0042)
  • Advanced Clinical Research ( Site 0038)
  • Heartland Research Associates, LLC ( Site 0029)
  • Heartland Research Associates, LLC ( Site 0015)
  • Cotton O'Neil Research Center ( Site 0014)
  • Kentucky Pediatric/Adult Research Inc ( Site 0012)
  • University of Louisville: Pediatric Clinical Trials Unit ( Site 0025)
  • ACC Pediatric Research ( Site 0041)
  • The Center For Pharmaceutical Research PC ( Site 0011)
  • Child Health Care Associates ( Site 0045)
  • Blue Ridge Pediatric & Adolescent Medicine ( Site 0001)
  • Ford, Simpson, Lively & Rice Pediatrics, PLLC ( Site 0037)
  • Senders Pediatrics ( Site 0034)
  • Ohio Pediatric Research Association ( Site 0035)
  • Kid's Way Pediatrics ( Site 0047)
  • Palmetto Pediatrics, PA ( Site 0023)
  • Coastal Pediatric Research ( Site 0006)
  • Holston Medical Group Pediatrics ( Site 0024)
  • Benchmark Research ( Site 0005)
  • University of Texas Medical Branch at Galveston ( Site 0032)
  • West Houston Clinical Research Services ( Site 0009)
  • Pediatric Healthcare of Northwest Houston ( Site 0027)
  • Tanner Clinic ( Site 0010)
  • Wee Care Pediatrics-Roy ( Site 0043)
  • J Lewis Research Inc / Foothill Family Clinic ( Site 0016)
  • J Lewis Research Inc/Foothill Family Clinic South ( Site 0004)
  • J Lewis Research Inc/Jordan River Family Medicine ( Site 0019)
  • Wee Care Pediatrics ( Site 0036)
  • Advanced Clinical Research ( Site 0020)
  • Pediatric Research of Charlottesville, LLC ( Site 0039)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®

VARIVAX® 2016 Commercial Process + M-M-R II®

Arm Description

VARIVAX® Passage Extension (PE34) Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91

VARIVAX® 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91

Outcomes

Primary Outcome Measures

Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers <1.25 gpELISA units/mL) at baseline.
Geometric Mean Titer of VZV Antibodies
The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.

Secondary Outcome Measures

Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)
The percentage of participants with fever ≥102.2 °F oral equivalent for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)
The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)
The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1
The percentage of participants with solicited (on a Vaccine Report Card) injection-site erythema, injection-site swelling, or injection-site pain/tenderness was assessed.
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness was assessed.
Percentage of Participants With One or More Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Percentage of Participants With One or More Serious Adverse Events
A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAEs ~180 days after vaccination 2 was reported.
Percentage of Participants With One or More Vaccine-Related Adverse Events
The percentage of participants with one or more vaccine-related adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)
All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 1. The percentage of participants with one or more systemic adverse events (incidence ≥4 participants in one or more of the vaccination groups) was reported.
Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence > 0)
All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 2. The percentage of participants with one or more systemic adverse events was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)
The percentage of participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and postvaccination serology contributing to the per-protocol analysis was assessed. Confidence interval is calculated if there are at least 5 subjects who are seropositive. Antibody titers were assessed using gpELISA.
Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody
Blood samples were taken at pre-vaccination (baseline) and approximately 43 days after vaccination 1 to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The geometric mean fold rise (GMFR) was calculated as GMT post vaccination 1/GMT pre-vaccination (baseline). Confidence interval is calculated if there are at least 5 subjects who are seropositive.
Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody
The percentage of participants with a geometric mean ≥4-fold rise from baseline of ≥1.25gpELISA units/mL in VZV antibody titer at approximately 43 days after vaccination 1 was assessed.
Percentage of Participants With One or More Vaccine-Related Serious Adverse Events
The percentage of participants with one or more vaccine-related serious adverse events up to ~180 days after vaccination 2 was reported. The study investigator determines whether the serious adverse event is related to the vaccine.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
The percentage of participants discontinued from the study due to an adverse event for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence > 0%)
The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence > 0%)
The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)
The percentage of participants with medically-attended AEs up to ~180 days after vaccination 2 that did not meet the definition of serious adverse event (incidence ≥5% in one or more vaccination groups) was reported.

Full Information

First Posted
August 1, 2017
Last Updated
January 12, 2021
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03239873
Brief Title
Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
Official Title
A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process Administered Concomitantly With M-M-R™ II
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX® 2016 commercial process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process, and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.

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 ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®
Arm Type
Experimental
Arm Description
VARIVAX® Passage Extension (PE34) Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91
Arm Title
VARIVAX® 2016 Commercial Process + M-M-R II®
Arm Type
Active Comparator
Arm Description
VARIVAX® 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91
Intervention Type
Biological
Intervention Name(s)
VARIVAX® PE34 Process
Intervention Description
Varicella virus vaccine live manufactured with a new passage extension process (PE34)
Intervention Type
Biological
Intervention Name(s)
VARIVAX® 2016 Commercial Process
Intervention Description
Varicella virus vaccine live manufactured with the 2016 commercial process
Intervention Type
Biological
Intervention Name(s)
M-M-R II®
Intervention Description
Measles, Mumps, and Rubella virus vaccine live
Primary Outcome Measure Information:
Title
Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Description
The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers <1.25 gpELISA units/mL) at baseline.
Time Frame
6 weeks (43 days) after vaccination 1
Title
Geometric Mean Titer of VZV Antibodies
Description
The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.
Time Frame
6 weeks (43 days) after vaccination 1
Secondary Outcome Measure Information:
Title
Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)
Description
The percentage of participants with fever ≥102.2 °F oral equivalent for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Time Frame
Up to 42 days after vaccination 1; Up to 42 days after vaccination 2
Title
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)
Description
The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Time Frame
Up to 42 days after vaccination 1
Title
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)
Description
The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Time Frame
Up to 42 days after vaccination 2
Title
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1
Description
The percentage of participants with solicited (on a Vaccine Report Card) injection-site erythema, injection-site swelling, or injection-site pain/tenderness was assessed.
Time Frame
Up to 5 days after vaccination 1
Title
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
Description
The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness was assessed.
Time Frame
Up to 5 days after vaccination 2
Title
Percentage of Participants With One or More Adverse Events
Description
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Time Frame
Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
Title
Percentage of Participants With One or More Serious Adverse Events
Description
A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAEs ~180 days after vaccination 2 was reported.
Time Frame
Up to ~180 days after vaccination 2 (Up to ~285 days)
Title
Percentage of Participants With One or More Vaccine-Related Adverse Events
Description
The percentage of participants with one or more vaccine-related adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Time Frame
Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
Title
Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)
Description
All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 1. The percentage of participants with one or more systemic adverse events (incidence ≥4 participants in one or more of the vaccination groups) was reported.
Time Frame
Up to 42 days after vaccination 1
Title
Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence > 0)
Description
All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 2. The percentage of participants with one or more systemic adverse events was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Time Frame
Up to 42 days after vaccination 2
Title
Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)
Description
The percentage of participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and postvaccination serology contributing to the per-protocol analysis was assessed. Confidence interval is calculated if there are at least 5 subjects who are seropositive. Antibody titers were assessed using gpELISA.
Time Frame
6 weeks (~43 days) after vaccination 1
Title
Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody
Description
Blood samples were taken at pre-vaccination (baseline) and approximately 43 days after vaccination 1 to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The geometric mean fold rise (GMFR) was calculated as GMT post vaccination 1/GMT pre-vaccination (baseline). Confidence interval is calculated if there are at least 5 subjects who are seropositive.
Time Frame
Baseline and 6 weeks (~43 days) after vaccination 1
Title
Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody
Description
The percentage of participants with a geometric mean ≥4-fold rise from baseline of ≥1.25gpELISA units/mL in VZV antibody titer at approximately 43 days after vaccination 1 was assessed.
Time Frame
Baseline and 6 weeks (~43 days) after vaccination 1
Title
Percentage of Participants With One or More Vaccine-Related Serious Adverse Events
Description
The percentage of participants with one or more vaccine-related serious adverse events up to ~180 days after vaccination 2 was reported. The study investigator determines whether the serious adverse event is related to the vaccine.
Time Frame
Up to ~180 days after vaccination 2
Title
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
Description
The percentage of participants discontinued from the study due to an adverse event for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Time Frame
Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
Title
Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence > 0%)
Description
The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Time Frame
Up to 42 days after vaccination 1
Title
Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence > 0%)
Description
The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Time Frame
Up to 42 days after vaccination 2
Title
Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)
Description
The percentage of participants with medically-attended AEs up to ~180 days after vaccination 2 that did not meet the definition of serious adverse event (incidence ≥5% in one or more vaccination groups) was reported.
Time Frame
Up to ~180 days after vaccination 2 (Up to ~285 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella 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 receive them during the course of the study History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX® or M-M-R II® Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems Received salicylates within 14 days prior to study vaccination Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination History of seizure disorder, including febrile seizure Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination History of thrombocytopenia Born to a human immunodeficiency virus (HIV)-infected mother Has a diagnosis of active untreated tuberculosis Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics ( Site 0018)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Children's Clinic of Jonesboro, PA ( Site 0030)
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Southland Clinical Research Center ( Site 0017)
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Premier Health Research Center, LLC ( Site 0044)
City
Downey
State/Province
California
ZIP/Postal Code
90240
Country
United States
Facility Name
California Research Foundation ( Site 0003)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
IMMUNOe Research Centers ( Site 0046)
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80233
Country
United States
Facility Name
Children's Research at Altamonte Pediatric Associates ( Site 0040)
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
University of South Florida ( Site 0042)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Advanced Clinical Research ( Site 0038)
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Heartland Research Associates, LLC ( Site 0029)
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Heartland Research Associates, LLC ( Site 0015)
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cotton O'Neil Research Center ( Site 0014)
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
Kentucky Pediatric/Adult Research Inc ( Site 0012)
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
University of Louisville: Pediatric Clinical Trials Unit ( Site 0025)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
ACC Pediatric Research ( Site 0041)
City
Haughton
State/Province
Louisiana
ZIP/Postal Code
71037
Country
United States
Facility Name
The Center For Pharmaceutical Research PC ( Site 0011)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Child Health Care Associates ( Site 0045)
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Blue Ridge Pediatric & Adolescent Medicine ( Site 0001)
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
Ford, Simpson, Lively & Rice Pediatrics, PLLC ( Site 0037)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Senders Pediatrics ( Site 0034)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Ohio Pediatric Research Association ( Site 0035)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Kid's Way Pediatrics ( Site 0047)
City
Hermitage
State/Province
Pennsylvania
ZIP/Postal Code
16148
Country
United States
Facility Name
Palmetto Pediatrics, PA ( Site 0023)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Coastal Pediatric Research ( Site 0006)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Holston Medical Group Pediatrics ( Site 0024)
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Benchmark Research ( Site 0005)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
University of Texas Medical Branch at Galveston ( Site 0032)
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
West Houston Clinical Research Services ( Site 0009)
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Pediatric Healthcare of Northwest Houston ( Site 0027)
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Tanner Clinic ( Site 0010)
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Wee Care Pediatrics-Roy ( Site 0043)
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
J Lewis Research Inc / Foothill Family Clinic ( Site 0016)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J Lewis Research Inc/Foothill Family Clinic South ( Site 0004)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
J Lewis Research Inc/Jordan River Family Medicine ( Site 0019)
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Wee Care Pediatrics ( Site 0036)
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
Facility Name
Advanced Clinical Research ( Site 0020)
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Pediatric Research of Charlottesville, LLC ( Site 0039)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
32429738
Citation
Silas PE, Zissman EN, Gardner J, Helian S, Lee AW, Platt HL. A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R II). Hum Vaccin Immunother. 2020 Nov 1;16(11):2634-2640. doi: 10.1080/21645515.2020.1743122. Epub 2020 May 19.
Results Reference
result

Learn more about this trial

Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)

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