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

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.

Completed

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Key information

Conditions

Varicella Chickenpox DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

12 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This treatment has been approved for sale to the public.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

Time frame: 6 weeks following first vaccination

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jan 14, 2009
Registry last updated: Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed