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

Merck Sharp & Dohme LLC150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Varicella

Interventions

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).

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 5816)

Kazan', Russia

Research Institute of Children Infections ( Site 5801)

Saint Petersburg, Russia

SPb Pasteur RI of Epidemiology and Microbiology ( Site 5817)

Saint Petersburg, Russia

Smolensk State Medical University ( Site 5814)

Smolensk, Russia

Outcomes

Primary Outcomes

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.

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 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.

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 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.

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)

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 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).

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

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.

Time frame: 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).

Time frame: 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.

Time frame: 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).

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

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.

Time frame: 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).

Time frame: 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.

Time frame: 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).

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

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.

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

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.

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

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.

Time frame: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)