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

    Summary
    EudraCT number
    		 2019-003903-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Jun 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 Mar 2021
    First version publication date
    20 Dec 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    V210-058
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03843632
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the immunogenicity of VARIVAX™ vaccine in healthy Russian children, adolescents, and adults. No formal hypothesis was tested.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 150
    Worldwide total number of subjects
    150
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    64
    Adolescents (12-17 years)
    36
    Adults (18-64 years)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study enrolled healthy Russians aged 12 months and older. Additional inclusion criteria applied.

    Pre-assignment
    Screening details
    		 150 participants were enrolled and received VARIVAX™ on study. Adults and Adolescents received 2 vaccinations on study and children received 1 vaccination.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VARIVAX Adults (18 to 75 years)
    Arm description
    		 Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VARIVAX™
    Investigational medicinal product code
    Other name
    Varicella Virus Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. Adult participants and adolescent participants 13 to 17 years of age also received a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.

    Arm title
    		 VARIVAX™ Adolescents 13 to 17 years of age
    Arm description
    		 Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VARIVAX™
    Investigational medicinal product code
    Other name
    Varicella Virus Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. Adult participants and adolescent participants 13 to 17 years of age also received a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.

    Arm title
    		 VARIVAX™ Children 7 to 12 years of age
    Arm description
    		 Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VARIVAX
    Investigational medicinal product code
    Other name
    Varicella Virus Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.

    Arm title
    		 VARIVAX™ Children 12 months to 6 years of age
    Arm description
    		 Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VARIVAX
    Investigational medicinal product code
    Other name
    Varicella Virus Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.

    Number of subjects in period 1
    		VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Started
    50
    30
    33
    37
    Vaccination 1
    50
    30
    33
    37
    Vaccination 2
    49
    30
    0 [1]
    0 [2]
    Completed
    49
    30
    33
    37
    Not completed
    1
    0
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only adults and adolescents 13 to 17 years of age received Vaccination 2.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only adults and adolescents 13 to 17 years of age received Vaccination 2.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VARIVAX Adults (18 to 75 years)
    Reporting group description
    		 Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.

    Reporting group title
    VARIVAX™ Adolescents 13 to 17 years of age
    Reporting group description
    		 Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.

    Reporting group title
    VARIVAX™ Children 7 to 12 years of age
    Reporting group description
    		 Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.

    Reporting group title
    VARIVAX™ Children 12 months to 6 years of age
    Reporting group description
    		 Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.

    Reporting group values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age Total
    Number of subjects
    		 50 30 33 37 100
    Age Categorical
    Units: Participants
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.7 ± 6.0 15.1 ± 1.5 9.6 ± 1.6 3.2 ± 1.6 -
    Gender Categorical
    Units: Participants
        Female
    		 36 16 14 18 84
        Male
    		 14 14 19 19 66
    Race
    Units: Subjects
        White
    		 50 30 33 37 150
    Ethnicity
    Units: Subjects
        Hispanic Or Latino
    		 1 0 0 0 1
        Not Hispanic Or Latino
    		 48 30 33 37 148
        Not Reported
    		 1 0 0 0 1
    Serostatus for Varicella-Zoster Virus (VZV)
    Units: Subjects
        VZV Seronegative
    		 26 18 22 34 100
        VZV Seropositive
    		 24 12 11 3 50

    End points

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    End points reporting groups
    Reporting group title
    VARIVAX Adults (18 to 75 years)
    Reporting group description
    		 Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.

    Reporting group title
    VARIVAX™ Adolescents 13 to 17 years of age
    Reporting group description
    		 Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.

    Reporting group title
    VARIVAX™ Children 7 to 12 years of age
    Reporting group description
    		 Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.

    Reporting group title
    VARIVAX™ Children 12 months to 6 years of age
    Reporting group description
    		 Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.

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

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    End point title
    		 Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline [1]
    End point description
    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. 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.
    End point type
    Primary
    End point 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)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no between-group statistical analyses for this endpoint.
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    26
    18
    22
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    100 (86.8 to 100.0)
    100 (81.5 to 100.0)
    95.5 (77.2 to 99.9)
    100.0 (89.7 to 100.0)
    No statistical analyses for this end point

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

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    End point title
    		 Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline [2]
    End point description
    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. 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.
    End point type
    Primary
    End point 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)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no between-group statistical analyses for this endpoint.
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    26
    18
    22
    34
    Units: gpELISA units/mL
        geometric mean (confidence interval 95%)
    70.7 (47.9 to 104.2)
    78.6 (46.5 to 133.0)
    11.3 (7.3 to 17.5)
    13.9 (11.2 to 17.2)
    No statistical analyses for this end point

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

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    End point title
    		 VZV Antibody Seroconversion Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline [3]
    End point description
    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. 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.
    End point type
    Primary
    End point 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)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no between-group statistical analyses for this endpoint.
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    26
    18
    22
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    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)
    No statistical analyses for this end point

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

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    End point title
    		 GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline [4]
    End point description
    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. Confidence intervals (CIs) were only calculated when there were at least 5 participants who were seropositive in a treatment group; missing CIs indicated by “9999”. 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.
    End point type
    Primary
    End point timeframe
    Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no between-group statistical analyses for this endpoint.
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    23
    12
    11
    3
    Units: gpELISA units/mL
    geometric mean (confidence interval 95%)
        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 (-9999 to 9999)
        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 (-9999 to 9999)
    No statistical analyses for this end point

    Primary: 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

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    End point title
    		 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 [5]
    End point description
    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. CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group; missing CIs indicated by “9999”. 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.
    End point type
    Primary
    End point timeframe
    Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no between-group statistical analyses for this endpoint.
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    23
    12
    11
    3
    Units: Ratio
        geometric mean (confidence interval 95%)
    3.0 (2.0 to 4.8)
    11.3 (4.6 to 27.5)
    5.0 (2.6 to 9.7)
    11.2 (-9999 to 9999)
    No statistical analyses for this end point

    Primary: 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

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    End point title
    		 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 [6]
    End point description
    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). CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group; missing CIs indicated by “9999”. 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.
    End point type
    Primary
    End point timeframe
    Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no between-group statistical analyses for this endpoint.
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    23
    12
    11
    3
    Units: Percentage of participants
        number (confidence interval 95%)
    60.9 (38.5 to 80.3)
    66.7 (34.9 to 90.1)
    54.5 (23.4 to 83.3)
    100.0 (-9999 to 9999)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1

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    End point title
    		 Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1
    End point description
    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. All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 days post-Vaccination 1
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    50
    30
    33
    37
    Units: Percentage of participants
    number (not applicable)
        Injection-site erythema
    16.0
    3.3
    3.0
    0.0
        Injection-site pain
    40.0
    23.3
    30.3
    13.5
        Injection-site swelling
    10.0
    0.0
    3.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2

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    End point title
    		 Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2
    End point description
    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). All allocated participants who received two doses of study vaccine (adults and adolescents) and who had some safety follow-up data after the respective vaccination were analyzed. The two children study arms did not receive a second vaccination and were excluded from this analysis
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 days post-Vaccination 2 (up to approximately 46 days)
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    49
    30
    0 [7]
    0 [8]
    Units: Percentage of participants
    number (not applicable)
        Injection-site erythema
    18.4
    0
        Injection-site pain
    49.0
    23.3
        Injection-site swelling
    8.2
    3.3
    Notes
    [7] - Participants who did not receive a 2nd dose were excluded from analysis.
    [8] - Participants who did not receive a 2nd dose were excluded from analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1

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    End point title
    		 Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1
    End point description
    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. All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to approximately 42 days post-Vaccination 1
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    50
    30
    33
    37
    Units: Percentage of participants
        number (not applicable)
    2.0
    3.3
    0.0
    5.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2

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    End point title
    		 Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2
    End point description
    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). All allocated participants who received two doses of study vaccine (adults and adolescents) and who had some safety follow-up data after the respective vaccination were analyzed. The two children study arms did not receive a second vaccination and were excluded from this analysis.
    End point type
    Secondary
    End point timeframe
    Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    49
    30
    0 [9]
    0 [10]
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    Notes
    [9] - Participants who did not receive a 2nd dose were excluded from analysis.
    [10] - Participants who did not receive a 2nd dose were excluded from analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Elevated Temperature Post-Vaccination 1

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    End point title
    		 Percentage of Participants With Elevated Temperature Post-Vaccination 1
    End point description
    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. All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 28 days post-Vaccination 1
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    50
    30
    33
    37
    Units: Percentage of participants
        number (not applicable)
    2.0
    0.0
    3.0
    8.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Elevated Temperature Post-Vaccination 2

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    End point title
    		 Percentage of Participants With Elevated Temperature Post-Vaccination 2
    End point description
    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). All allocated participants who received two doses of study vaccine (adults and adolescents) and who had some safety follow-up data after the respective vaccination were analyzed. The two children study arms did not receive a second vaccination and were excluded from this analysis.
    End point type
    Secondary
    End point timeframe
    Up to 28 days post-Vaccination 2 (up to approximately 71 days)
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    49
    30
    0 [11]
    0 [12]
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    Notes
    [11] - Participants who did not receive a 2nd dose were excluded from analysis.
    [12] - Participants who did not receive a 2nd dose were excluded from analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1

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    End point title
    		 Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1
    End point description
    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. All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to approximately 42 days post-Vaccination 1
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    50
    30
    33
    37
    Units: Percentage of participants
    number (not applicable)
        Varicella-like rash
    6.0
    0.0
    6.1
    2.7
        Herpes zoster-like rash
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2

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    End point title
    		 Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2
    End point description
    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 receiving a second vaccination (adults and adolescents). All allocated participants who received two doses of study vaccine (adults and adolescents) and who had some safety follow-up data after the respective vaccination were analyzed. The two children study arms did not receive a second vaccination and were excluded from this analysis.
    End point type
    Secondary
    End point timeframe
    Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    49
    30
    0 [13]
    0 [14]
    Units: Percentage of participants
        number (not applicable)
    2.0
    0.0
    Notes
    [13] - Participants who did not receive a 2nd dose were excluded from analysis.
    [14] - Participants who did not receive a 2nd dose were excluded from analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Systemic AEs Post-Vaccination 1

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    End point title
    		 Percentage of Participants With Systemic AEs Post-Vaccination 1
    End point description
    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. All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to approximately 42 days post-Vaccination 1
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    50
    30
    33
    37
    Units: Percentage of participants
        number (not applicable)
    38.0
    23.3
    36.4
    43.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Systemic AEs Post-Vaccination 2

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    End point title
    		 Percentage of Participants With Systemic AEs Post-Vaccination 2
    End point description
    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). All allocated participants who received two doses of study vaccine (adults and adolescents) and who had some safety follow-up data after the respective vaccination were analyzed. The two children study arms did not receive a second vaccination and were excluded from this analysis.
    End point type
    Secondary
    End point timeframe
    Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    49
    30
    0 [15]
    0 [16]
    Units: Percentage of participants
        number (not applicable)
    28.6
    26.7
    Notes
    [15] - Participants who did not receive a 2nd dose were excluded from analysis.
    [16] - Participants who did not receive a 2nd dose were excluded from analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2

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    End point title
    		 Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2
    End point description
    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. All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    50
    30
    33
    37
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    3.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2

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    End point title
    		 Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2
    End point description
    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. All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    50
    30
    33
    37
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2

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    End point title
    		 Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2
    End point description
    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. All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
    End point values
    		 VARIVAX Adults (18 to 75 years) VARIVAX™ Adolescents 13 to 17 years of age VARIVAX™ Children 7 to 12 years of age VARIVAX™ Children 12 months to 6 years of age
    Number of subjects analysed
    50
    30
    33
    37
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)
    Adverse event reporting additional description
    Serious and Non-serious AE tables include all allocated participants who received at least 1 dose of study vaccination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    VARIVAX Adults (18 to 75 years)
    Reporting group description
    		 Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.

    Reporting group title
    VARIVAX Adolescents (13 to 17 years)
    Reporting group description
    		 Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.

    Reporting group title
    VARIVAX Children (7 to 12 years)
    Reporting group description
    		 Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.

    Reporting group title
    VARIVAX Children (12 months to 6 years)
    Reporting group description
    		 Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.

    Serious adverse events
    		 VARIVAX Adults (18 to 75 years) VARIVAX Adolescents (13 to 17 years) VARIVAX Children (7 to 12 years) VARIVAX Children (12 months to 6 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 30 (0.00%)
    1 / 33 (3.03%)
    0 / 37 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 30 (0.00%)
    1 / 33 (3.03%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 VARIVAX Adults (18 to 75 years) VARIVAX Adolescents (13 to 17 years) VARIVAX Children (7 to 12 years) VARIVAX Children (12 months to 6 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 50 (80.00%)
    17 / 30 (56.67%)
    15 / 33 (45.45%)
    16 / 37 (43.24%)
    Investigations
    Body temperature increased
         subjects affected / exposed
    6 / 50 (12.00%)
    5 / 30 (16.67%)
    2 / 33 (6.06%)
    9 / 37 (24.32%)
         occurrences all number
    11
    10
    2
    13
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 50 (18.00%)
    6 / 30 (20.00%)
    5 / 33 (15.15%)
    0 / 37 (0.00%)
         occurrences all number
    15
    10
    5
    0
    General disorders and administration site conditions
    Injection site haemorrhage
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    2
    Injection site pain
         subjects affected / exposed
    29 / 50 (58.00%)
    10 / 30 (33.33%)
    10 / 33 (30.30%)
    5 / 37 (13.51%)
         occurrences all number
    45
    14
    10
    5
    Injection site erythema
         subjects affected / exposed
    16 / 50 (32.00%)
    1 / 30 (3.33%)
    1 / 33 (3.03%)
    0 / 37 (0.00%)
         occurrences all number
    17
    1
    1
    0
    Injection site swelling
         subjects affected / exposed
    7 / 50 (14.00%)
    1 / 30 (3.33%)
    1 / 33 (3.03%)
    0 / 37 (0.00%)
         occurrences all number
    9
    1
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    6
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash vesicular
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 30 (0.00%)
    2 / 33 (6.06%)
    1 / 37 (2.70%)
         occurrences all number
    4
    0
    2
    1
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 30 (0.00%)
    2 / 33 (6.06%)
    5 / 37 (13.51%)
         occurrences all number
    1
    0
    2
    5
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 50 (2.00%)
    2 / 30 (6.67%)
    1 / 33 (3.03%)
    4 / 37 (10.81%)
         occurrences all number
    1
    2
    1
    6
    Rhinitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Dec 2012
    Amendment 1: The primary reason for the amendment was to change the pregnancy/contraceptive follow-up period text so that it was consistent with the Investigator Brochure and the Product Label.
    18 Apr 2013
    Amendment 2: The primary reasons for this amendment were to update the study design to include the enrollment targets by age groups and specify the primary immunogenicity and safety endpoints of the study; and to add laboratory tests for participants 7 years of age and older.
    03 Oct 2018
    Amendment 3: The primary reasons for this amendment were to edit the title of the study remove “safety” and “tolerability” and to align it with the study’s primary focus of immunogenicity, and make its secondary objective that of safety and tolerability. The study design was also revised to include an adult cohort with a target enrollment of 50 participants. This cohort is referred to as Stage 1. Stage 2 would then enroll children and adolescents and follow sequentially after Stage 1. Additionally, the ages of children and adolescent participants in Stage 2 of the study were specified.
    18 Dec 2018
    Amendment 4: The primary reason for this amendment was to add an exclusion criterion to exclude participants who had (or their parents had) a documented human immunodeficiency virus (HIV) infection, untreated syphilis infection or viral hepatitis infection (Hepatitis B or C).
    30 Jul 2019
    Amendment 5: The primary reason for this amendment was to align the protocol with the current version of the Common Protocol Template (CPT).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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