Status:
COMPLETED
Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Varicella
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03843632
Start Date
March 1 2019
End Date
June 19 2020
Last Update
April 6 2021
Active Locations (5)
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1
Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 5816)
Kazan', Russia, 420140
2
Research Institute of Children Infections ( Site 5801)
Saint Petersburg, Russia, 197022
3
SPb Pasteur RI of Epidemiology and Microbiology ( Site 5817)
Saint Petersburg, Russia, 197101
4
Smolensk State Medical University ( Site 5814)
Smolensk, Russia, 214019