VaricellaPhase 3NCT03843632

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

A Phase 3 study testing VARIVAX™ in people with Varicella, run by Merck Sharp & Dohme LLC at 5 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 months to 75 yearsHealthy volunteers can take part
Conditions the study is for: Varicella
What is being tested?: VARIVAX™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 5 sitesRussia
Study dates: 1 Mar 2019to 19 Jun 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months to 75 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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 locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Russia5 sites

Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 5816)
Kazan', 420140
Research Institute of Children Infections ( Site 5801)
Saint Petersburg, 197022
SPb Pasteur RI of Epidemiology and Microbiology ( Site 5817)
Saint Petersburg, 197101
Smolensk State Medical University ( Site 5814)
Smolensk, 214019
Smolensk State Medical University ( Site 5815)
Smolensk, 214019

Other trials in Russia

About this study

Official title: An Open-Label, Multicenter, Single-arm Study to Evaluate the Immunogenicity of VARIVAX™ in Healthy Russian Individuals 12 Months of Age and Older

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.

Conditions: Varicella
Being tested: VARIVAX™
Medical subject headings: Chickenpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VARIVAX™Biological
VARIVAX™ administered by SC injection as 0.5 mL Varicella Virus Vaccine Live in sterile suspension on Day 1 (all participants) and Day 43 (adult and adolescent participants).

Study groups in NCT03843632
Study group	Role	What they receive
VARIVAX™	Experimental	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. Receives: Biological: VARIVAX™

What is being measured

The primary outcome is the main question the study is designed to answer.

Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
VZV antibody titers were measured using a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The VZV antibody response rate was defined as the percentage of participants with a post-vaccination VZV antibody titer ≥5 gpELISA units/mL for participants whose baseline VZV antibody titer was <1.25 gpELISA units/mL. VZV antibody response rate was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
Measured: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
Measured: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
VZV Antibody Seroconversion Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
VZV antibody levels were measured using a gpELISA. The VZW antibody seroconversion rate was defined as the percentage of participants with VZV antibodies ≥1.25 gpELISA units/mL in participants with a baseline VZV antibody titer <1.25 gpELISA units/mL. VZW antibody seroconversion was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
Measured: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline
GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, confidence intervals (CIs) were only calculated when there were at least 5 participants who were seropositive in a treatment group.
Measured: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline
GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the GMFR was calculated as the ratio of the VZV GMT at 6 weeks post last vaccination to the VZV GMT at Day 1 (baseline). The GMFR from Day 1 was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group.
Measured: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
Percentage of Participants With ≥4-Fold Rise in Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination Among Participants Who Were Seropositive at Baseline
GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the percentage of participants with a ≥4-fold rise in VZV antibody titer from Day 1 (baseline) to post-vaccination was assessed and reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents). Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group.
Measured: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)

Secondary outcomes (13)

Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs, which included erythema, pain, and swelling, were recorded on a Vaccine Report Card (VRC). The percentage of participants who experienced solicited injection-site AEs after Vaccination 1 (up to approximately 5 days post-vaccination) was summarized for all study arms.
Measured: Up to approximately 5 days post-Vaccination 1
Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs, which included erythema, pain, and swelling, were recorded on a VRC. The percentage of participants who experienced solicited injection-site AEs after Vaccination 2 (up to approximately 5 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents).
Measured: Up to approximately 5 days post-Vaccination 2 (up to approximately 48 days)
Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited injection-site AEs were recorded on a VRC. The percentage of participants who experienced unsolicited injection-site AEs after Vaccination 1 (up to approximately 42 days post-vaccination) was summarized for all study arms.
Measured: Up to approximately 42 days post-Vaccination 1
Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited injection-site AEs were recorded on a VRC. The percentage of participants who experienced unsolicited injection-site AEs after Vaccination 2 (up to approximately 42 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents).
Measured: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
Percentage of Participants With Elevated Temperature Post-Vaccination 1
The participant's temperature was taken in the evening after Vaccination 1 and daily through Day 28, and was recorded on a VRC. An elevated temperature was defined as ≥39.0 °C (102.2 °F). The percentage of participants with elevated temperature after Vaccination 1 (up to approximately 28 days post-vaccination) was summarized for all study arms.
Measured: Up to 28 days post-Vaccination 1
Percentage of Participants With Elevated Temperature Post-Vaccination 2
The participant's temperature was taken in the evening after Vaccination 2 and daily through Day 28, and was recorded on a VRC. An elevated temperature was defined as ≥39.0 °C (102.2 °F). The percentage of participants with elevated temperature after Vaccination 2 (up to approximately 28 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents).
Measured: Up to 28 days post-Vaccination 2 (up to approximately 71 days)
Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1
The development of varicella-like and herpes zoster-like rashes was recorded on a VRC. The percentage of participants who experienced varicella-like and herpes zoster-like rashes after Vaccination 1 (up to approximately 42 days post-vaccination) was summarized for all study arms.
Measured: Up to approximately 42 days post-Vaccination 1
Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2
The development of varicella-like and herpes zoster-like rashes was recorded on a VRC. The percentage of participants who experienced varicella-like and herpes zoster-like rashes after Vaccination 2 (up to approximately 42 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents).
Measured: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
Percentage of Participants With Systemic AEs Post-Vaccination 1
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A systemic AE was defined as any non-injection-site AE. Systemic AEs were recorded on a VRC. The percentage of participants who experienced a systemic AE after Vaccination 1 (up to approximately 42 days post-vaccination) was summarized for all study arms.
Measured: Up to approximately 42 days post-Vaccination 1
Percentage of Participants With Systemic AEs Post-Vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A systemic AE was defined as any non-injection-site AE. Systemic AEs were recorded on a VRC. The percentage of participants who experienced a systemic AE after Vaccination 2 (up to approximately 42 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents).
Measured: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or another important medical event. The percentage of participants who experienced one or more SAEs after either vaccination (up to approximately 42 days post-vaccination) was summarized for all study arms.
Measured: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A vaccine-related SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or another important medical event, that was considered at least possibly related to the study vaccine. The percentage of participants who experienced one or more vaccine-related SAEs after either vaccination (up to approximately 42 days post-vaccination) was summarized for all study arms.
Measured: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A vaccine-related SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or another important medical event, that was considered at least possibly related to the study vaccine. The percentage of participants who experienced a vaccine-related SAE that resulted in death after either vaccination (up to approximately 42 days post-vaccination) was summarized for all study arms.
Measured: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201919 Jun 2020

First posted18 Feb 2019
Study start1 Mar 2019
Primary completion19 Jun 2020
Study completion19 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for VaricellaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03843632
Sponsor's protocol ID: V210-058
Other IDs: V210-058, 2019-003903-36, 2019
Status last verified: Mar 2021
First submitted: 14 Feb 2019
Last updated: 6 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Paradis EM, Tikhonov O, Cao X, Kharit SM, Fokin A, Platt HL, Wittke F, Jotterand V. Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX) in healthy infants, children, and adolescents. Hum Vaccin Immunother. 2021 Nov 2;17(11):4183-4189. doi: 10.1080/21645515.2021.1975451. Epub 2021 Oct 26.
PubMed 34702124
Paradis EM, Tikhonov O, Cao X, Kharit SM, Fokin A, Platt HL, Banniettis N. Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX) in healthy adults. Hum Vaccin Immunother. 2021 Nov 2;17(11):4177-4182. doi: 10.1080/21645515.2021.1957414. Epub 2021 Sep 2.
PubMed 34473594

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter, Single-arm Study to Evaluate the Immunogenicity of VARIVAX™ in Healthy Russian Individuals 12 Months of Age and Older
ClinicalTrials.gov ID: NCT03843632
Acronym / sponsor ID: V210-058
Conditions: Varicella
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Mar 2019 (actual)
Primary completion: 19 Jun 2020 (actual)
Study completion: 19 Jun 2020 (actual)
First posted: 18 Feb 2019 (actual)
Results: Posted 6 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
VARIVAX™	Experimental	Biological: VARIVAX™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.

Who may qualify

Ages: 12 months to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VARIVAX™VARIVAX™ administered by SC injection as 0.5 mL Varicella Virus Vaccine Live in sterile suspension on Day 1 (all participants) and Day 43 (adult and adolescent participants).	Biological	VARIVAX™

Primary outcome

Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
Time frame: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
VZV antibody titers were measured using a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The VZV antibody response rate was defined as the percentage of participants with a post-vaccination VZV antibody titer ≥5 gpELISA units/mL for participants whose baseline VZV antibody titer was <1.25 gpELISA units/mL. VZV antibody response rate was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
Time frame: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
VZV Antibody Seroconversion Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
Time frame: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
VZV antibody levels were measured using a gpELISA. The VZW antibody seroconversion rate was defined as the percentage of participants with VZV antibodies ≥1.25 gpELISA units/mL in participants with a baseline VZV antibody titer <1.25 gpELISA units/mL. VZW antibody seroconversion was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline
Time frame: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, confidence intervals (CIs) were only calculated when there were at least 5 participants who were seropositive in a treatment group.
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline
Time frame: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the GMFR was calculated as the ratio of the VZV GMT at 6 weeks post last vaccination to the VZV GMT at Day 1 (baseline). The GMFR from Day 1 was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group.
Percentage of Participants With ≥4-Fold Rise in Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination Among Participants Who Were Seropositive at Baseline
Time frame: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the percentage of participants with a ≥4-fold rise in VZV antibody titer from Day 1 (baseline) to post-vaccination was assessed and reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents). Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group.

13 secondary outcomes

Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1
Time frame: Up to approximately 5 days post-Vaccination 1
Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2
Time frame: Up to approximately 5 days post-Vaccination 2 (up to approximately 48 days)
Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1
Time frame: Up to approximately 42 days post-Vaccination 1
Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2
Time frame: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
Percentage of Participants With Elevated Temperature Post-Vaccination 1
Time frame: Up to 28 days post-Vaccination 1
Percentage of Participants With Elevated Temperature Post-Vaccination 2
Time frame: Up to 28 days post-Vaccination 2 (up to approximately 71 days)
Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1
Time frame: Up to approximately 42 days post-Vaccination 1
Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2
Time frame: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
Percentage of Participants With Systemic AEs Post-Vaccination 1
Time frame: Up to approximately 42 days post-Vaccination 1
Percentage of Participants With Systemic AEs Post-Vaccination 2
Time frame: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2
Time frame: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2
Time frame: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2
Time frame: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)

Results and safety

Results posted to the registry on 6 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VARIVAX Adults (18 to 75 Years)	50	49
VARIVAX™ Adolescents 13 to 17 Years of Age	30	30
VARIVAX™ Children 7 to 12 Years of Age	33	33
VARIVAX™ Children 12 Months to 6 Years of Age	37	37

Primary outcome: Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline

Time frame: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	VARIVAX Adults (18 to 75 Years) n = 26	VARIVAX™ Adolescents 13 to 17 Years of Age n = 18	VARIVAX™ Children 7 to 12 Years of Age n = 22	VARIVAX™ Children 12 Months to 6 Years of Age n = 34
Value	100.0 (86.8 to 100.0)	100.0 (81.5 to 100.0)	95.5 (77.2 to 99.9)	100.0 (89.7 to 100.0)

Population analysed: All allocated participants without deviations from the protocol that would substantially affect the results of the immunogenicity outcome measures (Per-Protocol population) who were seronegative at baseline and who received Vaccination 1 (children) or Vaccination 1 and Vaccination 2 (adults and adolescents) were analyzed.

Primary outcome: Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline

Time frame: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days). Geometric mean (95% Confidence Interval). Unit: gpELISA units/mL

Measure	VARIVAX Adults (18 to 75 Years) n = 26	VARIVAX™ Adolescents 13 to 17 Years of Age n = 18	VARIVAX™ Children 7 to 12 Years of Age n = 22	VARIVAX™ Children 12 Months to 6 Years of Age n = 34
Value	70.7 (47.9)	78.6 (46.5)	11.3 (7.3)	13.9 (11.2)

Primary outcome: VZV Antibody Seroconversion Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline

Measure	VARIVAX Adults (18 to 75 Years) n = 26	VARIVAX™ Adolescents 13 to 17 Years of Age n = 18	VARIVAX™ Children 7 to 12 Years of Age n = 22	VARIVAX™ Children 12 Months to 6 Years of Age n = 34
Value	100.0 (86.8)	100.0 (81.5)	95.5 (77.2)	100.0 (89.7)

Primary outcome: GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline

Time frame: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents). Geometric mean (95% Confidence Interval). Unit: gpELISA units/mL

Measure	VARIVAX Adults (18 to 75 Years) n = 23	VARIVAX™ Adolescents 13 to 17 Years of Age n = 12	VARIVAX™ Children 7 to 12 Years of Age n = 11	VARIVAX™ Children 12 Months to 6 Years of Age n = 3
Day 1 (Baseline)	71.1 (31.4 to 161.2)	13.4 (5.8 to 31.0)	24.8 (7.2 to 85.5)	4.2 (NA to NA)
Post Last Vaccination	216.7 (132.8 to 353.6)	151.7 (92.5 to 248.6)	125.0 (37.9 to 411.7)	47.6 (NA to NA)

Population analysed: All allocated participants without deviations from the protocol that would substantially affect the results of the immunogenicity outcome measures (Per-Protocol population) who were seropositive at baseline and who received Vaccination 1 (children) or Vaccination 1 and Vaccination 2 (adults and adolescents) were analyzed.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days); All-Cause Mortality: Up to approximately 16 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VARIVAX Adults (18 to 75 Years)	0 of 50 (0%)	40 of 50 (80%)	0 of 50
VARIVAX Adolescents (13 to 17 Years)	0 of 30 (0%)	17 of 30 (56.7%)	0 of 30
VARIVAX Children (7 to 12 Years)	1 of 33 (3%)	15 of 33 (45.5%)	0 of 33
VARIVAX Children (12 Months to 6 Years)	0 of 37 (0%)	16 of 37 (43.2%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34702124Paradis EM, Tikhonov O, Cao X, Kharit SM, Fokin A, Platt HL, Wittke F, Jotterand V. Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX) in healthy infants, children, and adolescents. Hum Vaccin Immunother. 2021 Nov 2;17(11):4183-4189. doi: 10.1080/21645515.2021.1975451. Epub 2021 Oct 26.
Derived from this study: PubMed 34473594Paradis EM, Tikhonov O, Cao X, Kharit SM, Fokin A, Platt HL, Banniettis N. Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX) in healthy adults. Hum Vaccin Immunother. 2021 Nov 2;17(11):4177-4182. doi: 10.1080/21645515.2021.1957414. Epub 2021 Sep 2.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VARIVAX™ in people with Varicella, run by Merck Sharp & Dohme LLC at 5 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline (time frame: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03843632, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.