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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

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 42 days after vaccination 1 and up to 42 days after vaccination 2

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 1Eligibility criteria met