Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)

Merck Sharp & Dohme LLC598 enrolled

Overview

This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.

This treatment has been approved for sale to the public.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

598

Conditions

Varicella

Interventions

Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)BIOLOGICAL

VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart

Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)BIOLOGICAL

VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart

Measles, Mumps, and Rubella Virus Vaccine Live (MMR)BIOLOGICAL

M-M-R II in two 0.5 mL doses by injection \~6 weeks apart

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 23 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is in good health based on medical history * Subject has no history of measles, mumps, rubella, chickenpox, or shingles Exclusion Criteria: * Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination * Subject has history of immune disorders * Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start * Subject has received an inactivated vaccine within 14 days of first dose of study vaccine * Subject has received a live vaccine within 30 days of first dose of study vaccine * Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine * Subject has had a fever within 72 hours of study start

Outcomes

Primary Outcomes

Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).

Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer \< 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.

Time frame: 6 weeks following first vaccination

Data from ClinicalTrials.gov

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