Clinical trial NCT03843632: Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-02-18
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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

Primary outcomes:
measure: Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
timeFrame: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
measure: Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
timeFrame: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
measure: VZV Antibody Seroconversion Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
timeFrame: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
measure: GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline
timeFrame: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
measure: 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
timeFrame: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
measure: 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
timeFrame: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
Secondary outcomes:
measure: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1
timeFrame: Up to approximately 5 days post-Vaccination 1
measure: Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2
timeFrame: Up to approximately 5 days post-Vaccination 2 (up to approximately 48 days)
measure: Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1
timeFrame: Up to approximately 42 days post-Vaccination 1
measure: Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2
timeFrame: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
measure: Percentage of Participants With Elevated Temperature Post-Vaccination 1
timeFrame: Up to 28 days post-Vaccination 1
measure: Percentage of Participants With Elevated Temperature Post-Vaccination 2
timeFrame: Up to 28 days post-Vaccination 2 (up to approximately 71 days)
measure: Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1
timeFrame: Up to approximately 42 days post-Vaccination 1
measure: Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2
timeFrame: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
measure: Percentage of Participants With Systemic AEs Post-Vaccination 1
timeFrame: Up to approximately 42 days post-Vaccination 1
measure: Percentage of Participants With Systemic AEs Post-Vaccination 2
timeFrame: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
measure: Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2
timeFrame: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
measure: Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2
timeFrame: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
measure: Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2
timeFrame: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 5816)
city: Saint Petersburg
country: Russian Federation
facility: Research Institute of Children Infections ( Site 5801)
city: Saint Petersburg
country: Russian Federation
facility: SPb Pasteur RI of Epidemiology and Microbiology ( Site 5817)
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University ( Site 5814)
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University ( Site 5815)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.