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Vaccine

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

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 days after vaccination 1 and up to 42 days after vaccination 2
Awards & highlights

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.

Eligible Conditions
  • Chickenpox

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 days after vaccination 1 and up to 42 days after vaccination 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Geometric Mean Titer of VZV Antibodies
Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Secondary study objectives
Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®Experimental Treatment2 Interventions
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
Group II: VARIVAX® 2016 Commercial Process + M-M-R II®Active Control2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Measles virus vaccine live attenuated
FDA approved
Varicella zoster vaccine (live/attenuated)
FDA approved

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Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,999 Total Patients Enrolled
20 Trials studying Chickenpox
19,279 Patients Enrolled for Chickenpox
Merck Sharp & Dohme LLCLead Sponsor
3,956 Previous Clinical Trials
5,174,729 Total Patients Enrolled
23 Trials studying Chickenpox
19,341 Patients Enrolled for Chickenpox
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,841 Previous Clinical Trials
8,079,620 Total Patients Enrolled
7 Trials studying Chickenpox
5,791 Patients Enrolled for Chickenpox
~76 spots leftby Sep 2025
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