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    Clinical Trial Results:
    A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made with an Alternative Manufacturing Process (AMP)

    Summary
    EudraCT number
    		 2017-001443-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    27 Jan 2014

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V221-027
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01536405
    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
    27 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study compared the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process (MMRV [AMP]) with those of ProQuad™ (MMRV [2006 Process]). The primary hypothesis of the study was that MMRV (AMP) induces measles, mumps, rubella, and VZV antibody responses 6 weeks Postdose 1 that are non-inferior to those induced by MMRV (2006 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
    05 Jun 2012
    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: 1412
    Worldwide total number of subjects
    1412
    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)
    1412
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study enrolled healthy children 12- to 23-months of age with no clinical history for measles, mumps, rubella, varicella, or zoster.

    Pre-assignment
    Screening details
    		 One participant was inadvertently randomized twice, for a total of 1413 randomizations. The Subject Disposition tables below include this participant only once.

    Period 1
    Period 1 title
    Randomization to Visit 1 (Day 1)
    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
    		 MMRV (AMP)
    Arm description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process.
    Investigational medicinal product code
    Other name
    V221
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two 0.5 mL subcutaneous injections administered at Day 1 and Day 91

    Arm title
    		 MMRV (2006 Process)
    Arm description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process.
    Investigational medicinal product code
    Other name
    ProQuad™ V221
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two 0.5 mL subcutaneous injections administered at Day 1 and Day 91

    Number of subjects in period 1
    		MMRV (AMP) MMRV (2006 Process)
    Started
    706
    706
    Completed
    698
    702
    Not completed
    8
    4
         Not vaccinated
    8
    4
    Period 2
    Period 2 title
    Visit 1 (Day 1) to Visit 2 (Day 43)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MMRV (AMP)
    Arm description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process.
    Investigational medicinal product code
    Other name
    V221
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two 0.5 mL subcutaneous injections administered at Day 1 and Day 91

    Arm title
    		 MMRV (2006 Process)
    Arm description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process.
    Investigational medicinal product code
    Other name
    ProQuad™ V221
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two 0.5 mL subcutaneous injections administered at Day 1 and Day 91

    Number of subjects in period 2
    		MMRV (AMP) MMRV (2006 Process)
    Started
    698
    702
    Received Vaccination 1
    698
    702
    Completed
    666
    662
    Not completed
    32
    40
         Consent withdrawn by subject
    12
    18
         Lost to follow-up
    20
    22
    Period 3
    Period 3 title
    Visit 2 (Day 43) to Visit 3 (Day 91)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MMRV (AMP)
    Arm description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process.
    Investigational medicinal product code
    Other name
    V221
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two 0.5 mL subcutaneous injections administered at Day 1 and Day 91

    Arm title
    		 MMRV (2006 Process)
    Arm description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process.
    Investigational medicinal product code
    Other name
    ProQuad™ V221
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two 0.5 mL subcutaneous injections administered at Day 1 and Day 91

    Number of subjects in period 3
    		MMRV (AMP) MMRV (2006 Process)
    Started
    666
    662
    Completed
    635
    634
    Not completed
    31
    28
         Consent withdrawn by subject
    17
    13
         Adverse event, non-fatal
    3
    3
         Lost to follow-up
    9
    10
         Protocol deviation
    2
    2
    Period 4
    Period 4 title
    Visit 3 (Day 91) to Visit 4 (Day 133)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MMRV (AMP)
    Arm description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process.
    Investigational medicinal product code
    Other name
    V221
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two 0.5 mL subcutaneous injections administered at Day 1 and Day 91

    Arm title
    		 MMRV (2006 Process)
    Arm description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process.
    Investigational medicinal product code
    Other name
    ProQuad™ V221
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two 0.5 mL subcutaneous injections administered at Day 1 and Day 91

    Number of subjects in period 4
    		MMRV (AMP) MMRV (2006 Process)
    Started
    635
    634
    Received Vaccination 2
    634
    632
    Completed
    615
    618
    Not completed
    20
    16
         Consent withdrawn by subject
    3
    2
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    16
    14
    Period 5
    Period 5 title
    Visit 4 (Day 133) to Visit 5 (Day 271)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MMRV (AMP)
    Arm description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process.
    Investigational medicinal product code
    Other name
    V221
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two 0.5 mL subcutaneous injections administered at Day 1 and Day 91

    Arm title
    		 MMRV (2006 Process)
    Arm description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process.
    Investigational medicinal product code
    Other name
    ProQuad™ V221
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two 0.5 mL subcutaneous injections administered at Day 1 and Day 91

    Number of subjects in period 5
    		MMRV (AMP) MMRV (2006 Process)
    Started
    615
    618
    Completed
    595
    595
    Not completed
    20
    23
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MMRV (AMP)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])

    Reporting group title
    MMRV (2006 Process)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])

    Reporting group values
    		 MMRV (AMP) MMRV (2006 Process) Total
    Number of subjects
    		 706 706 1412
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 706 706 1412
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 13.4 ± 2.2 13.6 ± 2.5 -
    Gender Categorical
    Units: Subjects
        Female
    		 344 324 668
        Male
    		 362 382 744

    End points

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    End points reporting groups
    Reporting group title
    MMRV (AMP)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])

    Reporting group title
    MMRV (2006 Process)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])
    Reporting group title
    MMRV (AMP)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])

    Reporting group title
    MMRV (2006 Process)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])
    Reporting group title
    MMRV (AMP)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])

    Reporting group title
    MMRV (2006 Process)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])
    Reporting group title
    MMRV (AMP)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])

    Reporting group title
    MMRV (2006 Process)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])
    Reporting group title
    MMRV (AMP)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])

    Reporting group title
    MMRV (2006 Process)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])

    Subject analysis set title
    MMRV (AMP) - Received at Least One Vaccination
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received at least one 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)

    Subject analysis set title
    MMRV (2006 Process) - Received at Least one Vaccination
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received at least one 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

    Primary: Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL

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    End point title
    		 Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL
    End point description
    Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The population analyzed included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results.
    End point type
    Primary
    End point timeframe
    Six weeks after vaccination 1
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    586
    589
    Units: Percentage of participants
        number (confidence interval 95%)
    97.3 (95.6 to 98.4)
    93 (90.7 to 95)
    Statistical analysis title
    		 Non-inferiority Analysis
    Statistical analysis description
    The non-inferiority evaluation is based on the lower bound of the 2-sided 95% confidence interval (CI) on the risk difference excluding a decrease >= the prespecified criterion of 10 percentage points.
    Comparison groups
    MMRV (AMP) - Received at Least One Vaccination v MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects included in analysis
    1175
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 6.8
    Notes
    [1] - Risk Difference = MMRV (AMP) - MMRV (2006 process)

    Primary: Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL

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    End point title
    		 Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL
    End point description
    Sera were tested for measles virus IgG antibody levels by an ELISA. The population analyzed included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results.
    End point type
    Primary
    End point timeframe
    Six weeks after vaccination 1
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    629
    621
    Units: Percentage of participants
        number (confidence interval 95%)
    96.7 (94.9 to 97.9)
    98.9 (97.7 to 99.5)
    Statistical analysis title
    		 Non-inferiority Analysis
    Statistical analysis description
    The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease >= the prespecified criterion of 5 percentage points.
    Comparison groups
    MMRV (AMP) - Received at Least One Vaccination v MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects included in analysis
    1250
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.003
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 -0.6
    Notes
    [2] - Risk Difference = MMRV (AMP) - MMRV (2006 process)

    Primary: Percentage of Participants With Mumps Virus Antibody Levels >=10 Mumps Ab Units/mL

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    End point title
    		 Percentage of Participants With Mumps Virus Antibody Levels >=10 Mumps Ab Units/mL
    End point description
    Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA). The population analyzed included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results.
    End point type
    Primary
    End point timeframe
    Six weeks after vaccination 1
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    618
    610
    Units: Percentage of participants
        number (confidence interval 95%)
    98.2 (96.8 to 99.1)
    97.2 (95.6 to 98.4)
    Statistical analysis title
    		 Non-inferiority Analysis
    Statistical analysis description
    The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease >= the prespecified criterion of 5 percentage points.
    Comparison groups
    MMRV (AMP) - Received at Least One Vaccination v MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects included in analysis
    1228
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 2.8
    Notes
    [3] - Risk Difference = MMRV (AMP) - MMRV (2006 process)

    Primary: Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)

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    End point title
    		 Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)
    End point description
    Sera were tested for rubella virus IgG antibody levels by an ELISA. The population analyzed included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella serology results.
    End point type
    Primary
    End point timeframe
    Six weeks after vaccination 1
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    608
    593
    Units: Percentage of participants
        number (confidence interval 95%)
    98.8 (97.6 to 99.5)
    99.3 (98.3 to 99.8)
    Statistical analysis title
    		 Non-inferiority Analysis
    Statistical analysis description
    The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease >= the prespecified criterion of 5 percentage points.
    Comparison groups
    MMRV (AMP) - Received at Least One Vaccination v MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects included in analysis
    1201
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 0.7
    Notes
    [4] - Risk Difference = MMRV (AMP) - MMRV (2006 process)

    Primary: Geometric Mean Titer (GMT) of VZV Antibodies

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    End point title
    		 Geometric Mean Titer (GMT) of VZV Antibodies
    End point description
    Sera were tested for VZV IgG antibody levels by gpELISA. The population analyzed included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results.
    End point type
    Primary
    End point timeframe
    Six weeks after vaccination 1
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    586
    589
    Units: gpELISA Units/mL
        geometric mean (confidence interval 95%)
    17.3 (16.4 to 18.3)
    14.4 (13.6 to 15.2)
    Statistical analysis title
    		 Non-inferiority Analysis
    Statistical analysis description
    The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold. Analysis was based on log-transformed titers.
    Comparison groups
    MMRV (AMP) - Received at Least One Vaccination v MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects included in analysis
    1175
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 GMT Ratio
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.3
    Notes
    [5] - GMT ratio = MMRV (AMP) / MMRV (2006 process).

    Primary: Geometric Mean Titer (GMT) of Measles Virus Antibodies

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    End point title
    		 Geometric Mean Titer (GMT) of Measles Virus Antibodies
    End point description
    Sera were tested for measles virus IgG antibody levels by ELISA. The population analyzed included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results.
    End point type
    Primary
    End point timeframe
    Six weeks after vaccination 1
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    629
    621
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    3426.5 (3162.5 to 3712.4)
    3719.5 (3506 to 3946)
    Statistical analysis title
    		 Non-inferiority Analysis
    Statistical analysis description
    The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold. Analysis was based on log-transformed titers.
    Comparison groups
    MMRV (AMP) - Received at Least One Vaccination v MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects included in analysis
    1250
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 GMT Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1
    Notes
    [6] - GMT ratio = MMRV (AMP) / MMRV (2006 process).

    Primary: Geometric Mean Titer (GMT) of Mumps Virus Antibodies

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    End point title
    		 Geometric Mean Titer (GMT) of Mumps Virus Antibodies
    End point description
    Sera were tested for mumps virus IgG antibody levels by ELISA. The population analyzed included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results.
    End point type
    Primary
    End point timeframe
    Six weeks after vaccination 1
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    618
    610
    Units: Mumps Ab units/mL
        geometric mean (confidence interval 95%)
    112.1 (104.1 to 120.7)
    114 (105.8 to 122.8)
    Statistical analysis title
    		 Non-inferiority Analysis
    Statistical analysis description
    The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold. Analysis was based on log-transformed titers.
    Comparison groups
    MMRV (AMP) - Received at Least One Vaccination v MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects included in analysis
    1228
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.1
    Notes
    [7] - GMT ratio = MMRV (AMP) / MMRV (2006 process).

    Primary: Geometric Mean Titer (GMT) of Rubella Virus Antibodies

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    End point title
    		 Geometric Mean Titer (GMT) of Rubella Virus Antibodies
    End point description
    Sera were tested for rubella virus IgG antibody levels by ELISA. The population analyzed included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella virus serology results.
    End point type
    Primary
    End point timeframe
    Six weeks after vaccination 1
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    608
    593
    Units: IU/mL
        geometric mean (confidence interval 95%)
    81.8 (76.8 to 87.2)
    80.7 (76.4 to 85.2)
    Statistical analysis title
    		 Non-inferiority Analysis
    Statistical analysis description
    The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold. Analysis was based on log-transformed titers.
    Comparison groups
    MMRV (AMP) - Received at Least One Vaccination v MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects included in analysis
    1201
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.1
    Notes
    [8] - GMT ratio = MMRV (AMP) / MMRV (2006 process).

    Primary: Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

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    End point title
    		 Percentage of Participants With Fever (>=102.2°F [39.0°C] or 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 [39.0°C] or oral equivalent) was assessed. The population analyzed included participants who received >=1 study vaccination and had follow-up safety data.
    End point type
    Primary
    End point timeframe
    Up to 5 days after vaccination 1
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    645
    648
    Units: Percentage of participants
        number (not applicable)
    0.9
    0.8
    Statistical analysis title
    		 Non-inferiority Analysis
    Statistical analysis description
    The non-inferiority evaluation is based on the upper bound of the 2-sided 95% CI on the risk difference excluding an increase >= the prespecified criterion of 5 percentage points.
    Comparison groups
    MMRV (AMP) - Received at Least One Vaccination v MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects included in analysis
    1293
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1.3
    Notes
    [9] - Risk Difference = MMRV (AMP) - MMRV (2006 process)

    Secondary: Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

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    End point title
    		 Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
    End point description
    Daily temperatures were recorded using a standardized VRC. The percentage of participants with fever (>=102.2°F [39.0°C] or oral equivalent) was assessed. The population analyzed included participants who received >=1 study vaccination and had follow-up safety data.
    End point type
    Secondary
    End point timeframe
    Up to 42 days after each vaccination
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    650
    649
    Units: Percentage of participants
    number (not applicable)
        Vaccination 1: n=650, 649
    10
    10.6
        Vaccination 2: n=592, 597
    5.7
    8.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Zoster-like Rash

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    End point title
    		 Percentage of Participants With Zoster-like Rash
    End point description
    Zoster-like rash was solicited on the standardized VRC. The percentage of participants with zoster-like rash was assessed. The population analyzed included participants who received >=1 study vaccination and had follow-up safety data.
    End point type
    Secondary
    End point timeframe
    Up to 42 days after each vaccination
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    682
    682
    Units: Percentage of participants
    number (not applicable)
        Vaccination 1: n=682, 682
    0
    0
        Vaccination 2: n=634, 632
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Mumps-like Symptoms

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    End point title
    		 Percentage of Participants With Mumps-like Symptoms
    End point description
    Mumps-like symptoms were solicited on the standardized VRC. The percentage of participants with mumps-like symptoms was assessed. The population analyzed included participants who received >=1 study vaccination and had follow-up safety data.
    End point type
    Secondary
    End point timeframe
    Up to 42 days after each vaccination
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    682
    682
    Units: Percentage of participants
    number (not applicable)
        Vaccination 1: n=682, 682
    0
    0
        Vaccination 2: n=634, 632
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Measles-like Rash

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    End point title
    		 Percentage of Participants With Measles-like Rash
    End point description
    Measles-like rash was solicited on the standardized VRC. The percentage of participants with measles-like rash was assessed. The population analyzed included participants who received >=1 study vaccination and had follow-up safety data.
    End point type
    Secondary
    End point timeframe
    Up to 42 days after each vaccination
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    682
    682
    Units: Percentage of participants
    number (not applicable)
        Vaccination 1: n=682, 682
    0.1
    0.3
        Vaccination 2: n=634, 632
    0.2
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Rubella-like Rash

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    End point title
    		 Percentage of Participants With Rubella-like Rash
    End point description
    Rubella-like rash was solicited on the standardized VRC. The percentage of participants with rubella-like rash was assessed. The population analyzed included participants who received >=1 study vaccination and had follow-up safety data.
    End point type
    Secondary
    End point timeframe
    Up to 42 days after each vaccination
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    682
    682
    Units: Percentage of participants
    number (not applicable)
        Vaccination 1: n=682, 682
    0
    0
        Vaccination 2: n=634, 632
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Varicella-like Rash

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    End point title
    		 Percentage of Participants With Varicella-like Rash
    End point description
    Varicella-like rash was solicited on the standardized VRC. The percentage of participants with varicella-like rash was assessed. The population analyzed included participants who received >=1 study vaccination and had follow-up safety data.
    End point type
    Secondary
    End point timeframe
    Up to 42 days after each vaccination
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    682
    682
    Units: Percentage of participants
    number (not applicable)
        Vaccination 1: n=682, 682
    0.6
    0
        Vaccination 2; n=634, 632
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With an Injection-site Adverse Event

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    End point title
    		 Percentage of Participants With an Injection-site Adverse Event
    End point description
    An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs were solicited on the standardized VRC. The percentage of participants with a VRC-solicited injection-site AE was assessed. The population analyzed included participants who received >=1 study vaccination and had follow-up safety data.
    End point type
    Secondary
    End point timeframe
    Up to 5 days after each vaccination
    End point values
    		 MMRV (AMP) - Received at Least One Vaccination MMRV (2006 Process) - Received at Least one Vaccination
    Number of subjects analysed
    682
    682
    Units: Percentage of participants
    number (not applicable)
        Vaccination 1: n=682, 682
    36.4
    29.8
        Vaccination 2: n=634, 632
    35.5
    29.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 6 months (180 days) after vaccination 2
    Adverse event reporting additional description
    The population analyzed included randomized participants who received >=1 dose of study vaccine and had safety follow-up results.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    MMRV (2006 Process)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with the 2006 manufacturing process (MMRV [2006 Process])

    Reporting group title
    MMRV (AMP)
    Reporting group description
    		 Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella vaccine made with an alternative manufacturing process (MMRV [AMP])

    Serious adverse events
    		 MMRV (2006 Process) MMRV (AMP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 683 (2.64%)
    21 / 682 (3.08%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Exposure via direct contact
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exposure via ingestion
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 683 (0.15%)
    4 / 682 (0.59%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 683 (0.44%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (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 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Juvenile idiopathic arthritis
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    2 / 683 (0.29%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    2 / 683 (0.29%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 683 (0.00%)
    2 / 682 (0.29%)
         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 / 683 (0.15%)
    0 / 682 (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
    1 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (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 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    2 / 683 (0.29%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 683 (0.15%)
    0 / 682 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 683 (0.15%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval abscess
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         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
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 683 (0.00%)
    2 / 682 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 683 (0.00%)
    1 / 682 (0.15%)
         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
    		 MMRV (2006 Process) MMRV (AMP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    572 / 683 (83.75%)
    574 / 682 (84.16%)
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    187 / 683 (27.38%)
    208 / 682 (30.50%)
         occurrences all number
    243
    267
    Injection site erythema
         subjects affected / exposed
    199 / 683 (29.14%)
    254 / 682 (37.24%)
         occurrences all number
    258
    344
    Pyrexia
         subjects affected / exposed
    235 / 683 (34.41%)
    225 / 682 (32.99%)
         occurrences all number
    360
    349
    Injection site swelling
         subjects affected / exposed
    123 / 683 (18.01%)
    156 / 682 (22.87%)
         occurrences all number
    146
    190
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    46 / 683 (6.73%)
    48 / 682 (7.04%)
         occurrences all number
    47
    52
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    91 / 683 (13.32%)
    77 / 682 (11.29%)
         occurrences all number
    107
    98
    Vomiting
         subjects affected / exposed
    61 / 683 (8.93%)
    60 / 682 (8.80%)
         occurrences all number
    72
    77
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    53 / 683 (7.76%)
    58 / 682 (8.50%)
         occurrences all number
    64
    78
    Cough
         subjects affected / exposed
    101 / 683 (14.79%)
    87 / 682 (12.76%)
         occurrences all number
    118
    113
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    77 / 683 (11.27%)
    62 / 682 (9.09%)
         occurrences all number
    106
    76
    Rash
         subjects affected / exposed
    47 / 683 (6.88%)
    48 / 682 (7.04%)
         occurrences all number
    55
    50
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    41 / 683 (6.00%)
    29 / 682 (4.25%)
         occurrences all number
    43
    32
    Otitis media acute
         subjects affected / exposed
    44 / 683 (6.44%)
    56 / 682 (8.21%)
         occurrences all number
    57
    72
    Nasopharyngitis
         subjects affected / exposed
    66 / 683 (9.66%)
    55 / 682 (8.06%)
         occurrences all number
    76
    65
    Otitis media
         subjects affected / exposed
    128 / 683 (18.74%)
    128 / 682 (18.77%)
         occurrences all number
    179
    177
    Pharyngitis
         subjects affected / exposed
    35 / 683 (5.12%)
    40 / 682 (5.87%)
         occurrences all number
    43
    47
    Viral infection
         subjects affected / exposed
    57 / 683 (8.35%)
    44 / 682 (6.45%)
         occurrences all number
    64
    52
    Upper respiratory tract infection
         subjects affected / exposed
    163 / 683 (23.87%)
    159 / 682 (23.31%)
         occurrences all number
    212
    210

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2012
    Amendment 1: The amendment incorporated a new primary objective for safety and a new co-primary hypothesis for immunogenicity.

    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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