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    Clinical Trial Results:
    A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly with M-M-R™ II

    Summary
    EudraCT number
    		 2017-001444-35
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jun 2017
    First version publication date
    17 Jun 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V210-063
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02062502
    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
    13 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study evaluated the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypothesis tested was that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process.
    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
    07 Mar 2014
    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
    United States: 611
    Worldwide total number of subjects
    611
    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)
    611
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study enrolled healthy children 12- to 23-months of age who had not received measles, mumps, rubella, or varicella vaccine.

    Pre-assignment
    Screening details
    		 A total of 654 participants were screened and 611 were enrolled in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VARIVAX™ New Seed Process + M-M-R II™
    Arm description
    		 VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91
    Arm type
    		 Experimental

    Investigational medicinal product name
    VARIVAX™ New Seed Process
    Investigational medicinal product code
    Other name
    Varicella Virus Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.

    Investigational medicinal product name
    M-M-R II™ for Co-administration
    Investigational medicinal product code
    Other name
    Measles, Mumps, and Rubella Virus Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL administered in the left arm by subcutaneous injection on Day 1 and Day 91.

    Arm title
    		 VARIVAX™ 2007 Process + M-M-R II™
    Arm description
    		 VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    VARIVAX™ 2007 Process
    Investigational medicinal product code
    Other name
    Varicella Virus Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL administered in the left arm by subcutaneous injection on Day 1 and Day 91.

    Investigational medicinal product name
    M-M-R II™ for Co-administration
    Investigational medicinal product code
    Other name
    Measles, Mumps, and Rubella Virus Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.

    Number of subjects in period 1
    		VARIVAX™ New Seed Process + M-M-R II™ VARIVAX™ 2007 Process + M-M-R II™
    Started
    306
    305
    Vaccinated Dose 1
    306
    305
    Completed
    263
    270
    Not completed
    43
    35
         Physician decision
    -
    1
         Death
    -
    1
         Lost to follow-up
    18
    14
         Withdrawal by parent/guardian
    22
    18
         Protocol deviation
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VARIVAX™ New Seed Process + M-M-R II™
    Reporting group description
    		 VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91

    Reporting group title
    VARIVAX™ 2007 Process + M-M-R II™
    Reporting group description
    		 VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.

    Reporting group values
    		 VARIVAX™ New Seed Process + M-M-R II™ VARIVAX™ 2007 Process + M-M-R II™ Total
    Number of subjects
    		 306 305 611
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 306 305 611
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 12.9 ± 1.9 12.8 ± 1.7 -
    Gender Categorical
    Units: Subjects
        Female
    		 140 139 279
        Male
    		 166 166 332

    End points

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    End points reporting groups
    Reporting group title
    VARIVAX™ New Seed Process + M-M-R II™
    Reporting group description
    		 VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91

    Reporting group title
    VARIVAX™ 2007 Process + M-M-R II™
    Reporting group description
    		 VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.

    Primary: Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL

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    End point title
    		 Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
    End point description
    Anti-VZV antibody levels were measured using a gpELISA assay. The percentage of participants with antibody levels >=5 gpELISA Units/mL was assessed. The analysis population was participants with a seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.
    End point type
    Primary
    End point timeframe
    6 weeks (43 days) after vaccination 1
    End point values
    		 VARIVAX™ New Seed Process + M-M-R II™ VARIVAX™ 2007 Process + M-M-R II™
    Number of subjects analysed
    254
    254
    Units: Percentage of participants
        number (confidence interval 95%)
    97.2 (94.4 to 98.9)
    97.2 (94.4 to 98.9)
    Statistical analysis title
    		 Risk Difference in Response Rates
    Statistical analysis description
    The conclusion of non-inferiority is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.
    Comparison groups
    VARIVAX™ New Seed Process + M-M-R II™ v VARIVAX™ 2007 Process + M-M-R II™
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 3.2

    Primary: Geometric Mean Titer of VZV Antibodies

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    End point title
    		 Geometric Mean Titer of VZV Antibodies
    End point description
    Anti-VZV antibody levels were measured using a gpELISA assay. The Geometric Mean Titer was assessed. The analysis population was participants with a seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.
    End point type
    Primary
    End point timeframe
    6 weeks (43 days) after vaccination 1
    End point values
    		 VARIVAX™ New Seed Process + M-M-R II™ VARIVAX™ 2007 Process + M-M-R II™
    Number of subjects analysed
    254
    254
    Units: gpELISA units/mL
        geometric mean (confidence interval 95%)
    16.3 (15.1 to 17.6)
    17.2 (15.8 to 18.7)
    Statistical analysis title
    		 Non-inferiority
    Statistical analysis description
    The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on fold-difference, excluding a decrease of 1.5 fold or more.
    Comparison groups
    VARIVAX™ New Seed Process + M-M-R II™ v VARIVAX™ 2007 Process + M-M-R II™
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 GMT Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.06

    Secondary: Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)

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    End point title
    		 Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)
    End point description
    Daily temperatures were recorded using a standardized Vaccination Report Card (VRC). The percentage of participants with fever (>=102.2 °F oral equivalent) was assessed. The analysis population is All Subjects as Treated with results after Vaccination 1 or 2.
    End point type
    Secondary
    End point timeframe
    Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)
    End point values
    		 VARIVAX™ New Seed Process + M-M-R II™ VARIVAX™ 2007 Process + M-M-R II™
    Number of subjects analysed
    291
    293
    Units: Percentage of participants
    number (not applicable)
        Up to 42 days after Vaccination 1: n=285, 287
    9.5
    10.5
        Up to 42 days after Vaccination 2: n=258, 267
    8.1
    8.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1

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    End point title
    		 Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
    End point description
    The development of varicella-like, herpes zoster-like, measles-like and rubella-like rashes and mumps-like symptoms was recorded on the VRC. The analysis population is All Subjects as Treated with results after Vaccination 1.
    End point type
    Secondary
    End point timeframe
    Up to 42 days after Vaccination 1
    End point values
    		 VARIVAX™ New Seed Process + M-M-R II™ VARIVAX™ 2007 Process + M-M-R II™
    Number of subjects analysed
    291
    293
    Units: Percentage of participants
    number (not applicable)
        Measles-like rash
    0.3
    2.4
        Mumps-like symptoms
    0
    0
        Rubella-like rash
    0
    0
        Varicella-like rash
    0
    0.3
        Zoster-like rash
    0
    0
        Injection-site rash
    0.3
    1.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2

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    End point title
    		 Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
    End point description
    The development of varicella-like, herpes zoster-like, measles-like and rubella-like rashes and mumps-like symptoms was recorded on the VRC. The analysis population is All Subjects as Treated with results after Vaccination 2.
    End point type
    Secondary
    End point timeframe
    Up to 42 days after Vaccination 2
    End point values
    		 VARIVAX™ New Seed Process + M-M-R II™ VARIVAX™ 2007 Process + M-M-R II™
    Number of subjects analysed
    277
    276
    Units: Percentage of participants
    number (not applicable)
        Measles-like rash
    0
    0
        Mumps-like symptoms
    0
    0
        Rubella-like rash
    0
    0
        Varicella-like rash
    0.4
    0
        Zoster-like rash
    0
    0
        Injection-site rash
    0.7
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1

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    End point title
    		 Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
    End point description
    The development of injection-site erythema, swelling, and pain/tenderness was recorded on the VRC. The analysis population is All Subjects as Treated with results after Vaccination 1.
    End point type
    Secondary
    End point timeframe
    Up to 5 days after Vaccination 1
    End point values
    		 VARIVAX™ New Seed Process + M-M-R II™ VARIVAX™ 2007 Process + M-M-R II™
    Number of subjects analysed
    291
    293
    Units: Percentage of participants
    number (not applicable)
        Injection-site erythema
    20.3
    19.8
        Injection-site swelling
    10
    10.6
        Injection-site pain/tenderness
    29.9
    28
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2

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    End point title
    		 Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
    End point description
    The development of injection-site erythema, swelling, and pain/tenderness was recorded on the VRC. The analysis population is All Subjects as Treated with results after Vaccination 2.
    End point type
    Secondary
    End point timeframe
    Up to 5 days after Vaccination 2
    End point values
    		 VARIVAX™ New Seed Process + M-M-R II™ VARIVAX™ 2007 Process + M-M-R II™
    Number of subjects analysed
    277
    276
    Units: Percentage of participants
    number (not applicable)
        Injection-site erythema
    20.6
    22.5
        Injection-site swelling
    16.2
    12
        Injection-site pain/tenderness
    22.4
    24.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
    Adverse event reporting additional description
    The safety population is All Subjects as Treated with safety results.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    VARIVAX™ 2007 Process + M-M-R II™
    Reporting group description
    		 VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.

    Reporting group title
    VARIVAX™ New Seed Process + M-M-R II™
    Reporting group description
    		 VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91

    Serious adverse events
    		 VARIVAX™ 2007 Process + M-M-R II™ VARIVAX™ New Seed Process + M-M-R II™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 293 (3.07%)
    6 / 291 (2.06%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    3 / 293 (1.02%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 293 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 293 (0.34%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 293 (0.34%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 VARIVAX™ 2007 Process + M-M-R II™ VARIVAX™ New Seed Process + M-M-R II™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    224 / 293 (76.45%)
    225 / 291 (77.32%)
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    94 / 293 (32.08%)
    95 / 291 (32.65%)
         occurrences all number
    190
    181
    Injection site pain
         subjects affected / exposed
    117 / 293 (39.93%)
    106 / 291 (36.43%)
         occurrences all number
    270
    272
    Injection site swelling
         subjects affected / exposed
    59 / 293 (20.14%)
    61 / 291 (20.96%)
         occurrences all number
    96
    110
    Pyrexia
         subjects affected / exposed
    60 / 293 (20.48%)
    60 / 291 (20.62%)
         occurrences all number
    87
    86
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    22 / 293 (7.51%)
    37 / 291 (12.71%)
         occurrences all number
    25
    42
    Vomiting
         subjects affected / exposed
    18 / 293 (6.14%)
    28 / 291 (9.62%)
         occurrences all number
    21
    34
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    25 / 293 (8.53%)
    18 / 291 (6.19%)
         occurrences all number
    29
    20
    Nasal congestion
         subjects affected / exposed
    17 / 293 (5.80%)
    9 / 291 (3.09%)
         occurrences all number
    18
    9
    Rhinorrhoea
         subjects affected / exposed
    26 / 293 (8.87%)
    31 / 291 (10.65%)
         occurrences all number
    35
    37
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    27 / 293 (9.22%)
    25 / 291 (8.59%)
         occurrences all number
    30
    28
    Rash
         subjects affected / exposed
    14 / 293 (4.78%)
    23 / 291 (7.90%)
         occurrences all number
    14
    27
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    13 / 293 (4.44%)
    17 / 291 (5.84%)
         occurrences all number
    18
    18
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    15 / 293 (5.12%)
    12 / 291 (4.12%)
         occurrences all number
    15
    12
    Otitis media
         subjects affected / exposed
    33 / 293 (11.26%)
    35 / 291 (12.03%)
         occurrences all number
    36
    38
    Otitis media acute
         subjects affected / exposed
    14 / 293 (4.78%)
    23 / 291 (7.90%)
         occurrences all number
    16
    24
    Upper respiratory tract infection
         subjects affected / exposed
    44 / 293 (15.02%)
    46 / 291 (15.81%)
         occurrences all number
    51
    59
    Viral rash
         subjects affected / exposed
    17 / 293 (5.80%)
    6 / 291 (2.06%)
         occurrences all number
    18
    6

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Feb 2014
    Amendment 1: modified to include the new co-primary immunogenicity objective and hypothesis; added extended safety follow-up period (through Day 271); modified exclusion criteria; increased sample size; included GMTs (including VZV antibody as primary endpoints.
    13 May 2014
    Amendment 2: modified exclusion criterion.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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