Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Varicella

Treatments: Biological: VARIVAX™

Study type: Interventional

Funder types: Industry

Identifiers

NCT03843632

V210-058 (Other Identifier)

2019-003903-36 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study was to evaluate the immunogenicity and safety of VARIVAX™ vaccine in healthy Russian children, adolescents, and adults. No formal hypothesis was tested.

Enrollment: 150 patients

Sex: All

Ages: 12 months to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• has a negative clinical history for varicella and herpes zoster
• females of reproductive potential have a negative pregnancy test prior to each study vaccination
• females of reproductive potential remain abstinent or use 2 acceptable methods of birth control during study until 3 months following last study vaccination
• females not of reproductive potential do not require a pregnancy test or use of contraceptives
• legal representative of adult or parent of children understands risks involved with, consent to participate in, and comply with the study procedures

Exclusion criteria

• has a history of allergy or anaphylactic reaction to neomycin, gelatin, or any component of VARIVAX^TM
• has received any form of varicella or herpes zoster vaccine at any time prior to study, or anticipates receiving any during study
• has received immune globulin, a blood transfusion or blood derived products within prior 5 months or plans to do so during study
• has received aspirin or any aspirin-containing products within prior 14 days
• has been exposed to varicella or herpes zoster in the prior 4 weeks involving playmate, hospital or continuous household contact, or had contact with a newborn whose mother had chickenpox 5 days before or 2 days after delivery
• has, or lives with a person who has, any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity including those resulting from corticosteroid use or other immunosuppressive therapy
• has received glucocorticosteroids for more than 5 consecutive days within prior 3 months, or any dose of glucocorticoids within prior 7 days, or expects to use glucocorticosteroids during the study
• was vaccinated with licensed non-live or live vaccine within prior 30 days or expects vaccination during 42 day follow-up postvaccination period
• had a fever within 72 hours prior to study vaccination
• has participated in another trial within prior 30 days, is currently participating in another trial, or plans to participate in another trial during the planned study period for this trial
• is pregnant or nursing

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

VARIVAX™

Experimental group

Description:

All participants will receive one dose subcutaneous (SC) VARIVAX™ on Day 1. Adult participants and adolescent participants 13 years and older will also receive a second SC dose VARIVAX™ on Day 43.

Treatment:

Biological: VARIVAX™