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    Clinical Trial Results:
    A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process

    Summary
    EudraCT number
    2006-003648-46
    Trial protocol
    FI  
    Global end of trial date
    03 Jun 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    03 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V121-019
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00441012
    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
    Merck Sharp & Dohme Corp., Clinical Trials Disclosure, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Merck Sharp & Dohme Corp., Clinical Trials Disclosure, 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
    03 Jun 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jun 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus surface antigen) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine.
    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
    06 Dec 2006
    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
    Finland: 426
    Country: Number of subjects enrolled
    Canada: 120
    Worldwide total number of subjects
    546
    EEA total number of subjects
    426
    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)
    546
    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
    -

    Pre-assignment
    Screening details
    Participants were excluded for history of or prior vaccination for hepatitis B (Hep B) or Haemophilus influenzae Type B (Hib) disease and for administration of blood products. Participants also excluded if mother received Hep B, Hib vaccine, or blood products 6 months prior to participant birth. Other inclusion and exclusion criteria applied.

    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
    Modified Process Vaccine
    Arm description
    Modified process vaccine HBsAg and Polyribosylribitol Phosphate (PRP) in a 3-dose regimen at 2, 4, and 12 months of age. All participants also received Prevnar® vaccine in a 4-dose regimen at 2, 4, 6, and 12 months of age. Duration of treatment is 11 months.
    Arm type
    Experimental

    Investigational medicinal product name
    Modified Process Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Modified process vaccine HBsAg 5 ug/0.5 mL and PRP 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age

    Investigational medicinal product name
    Prevnar® Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Prevnar® Vaccine 0.5 mL intramuscular injection (in the limb opposing that used for Modified Process Vaccine injection) in a 4-dose regimen at 2, 4, 6, and 12 months of age

    Arm title
    COMVAX™ Vaccine
    Arm description
    COMVAX™ vaccine HBsAg and PRP in a 3-dose regimen at 2, 4, and 12 months of age. All participants also received Prevnar® vaccine in a 4-dose regimen at 2, 4, 6, and 12 months of age. Duration of treatment is 11 months.
    Arm type
    Active comparator

    Investigational medicinal product name
    COMVAX™ Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    COMVAX™ vaccine HBsAg 5 ug/0.5 mL and PRP 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age

    Investigational medicinal product name
    Prevnar® vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Prevnar® Vaccine 0.5 mL intramuscular injection (in the limb opposing that used for Modified Process Vaccine injection) in a 4-dose regimen at 2, 4, 6, and 12 months of age

    Number of subjects in period 1
    Modified Process Vaccine COMVAX™ Vaccine
    Started
    270
    276
    Received first dose of study vaccine
    269
    276
    Received second dose of study vaccine
    267
    272
    Received third dose of study vaccine
    265
    269
    Completed
    252
    263
    Not completed
    18
    13
         Protocol deviation
    10
    9
         Randomized but not vaccinated
    1
    -
         Adverse event, non-fatal
    -
    1
         Consent withdrawn by subject
    4
    -
         Lost to follow-up
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Modified Process Vaccine
    Reporting group description
    Modified process vaccine HBsAg and Polyribosylribitol Phosphate (PRP) in a 3-dose regimen at 2, 4, and 12 months of age. All participants also received Prevnar® vaccine in a 4-dose regimen at 2, 4, 6, and 12 months of age. Duration of treatment is 11 months.

    Reporting group title
    COMVAX™ Vaccine
    Reporting group description
    COMVAX™ vaccine HBsAg and PRP in a 3-dose regimen at 2, 4, and 12 months of age. All participants also received Prevnar® vaccine in a 4-dose regimen at 2, 4, 6, and 12 months of age. Duration of treatment is 11 months.

    Reporting group values
    Modified Process Vaccine COMVAX™ Vaccine Total
    Number of subjects
    270 276 546
    Age categorical
    Units: Subjects
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    67.7 ± 8.9 68.3 ± 8.5 -
    Gender categorical
    Units: Subjects
        Female
    129 142 271
        Male
    141 134 275

    End points

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    End points reporting groups
    Reporting group title
    Modified Process Vaccine
    Reporting group description
    Modified process vaccine HBsAg and Polyribosylribitol Phosphate (PRP) in a 3-dose regimen at 2, 4, and 12 months of age. All participants also received Prevnar® vaccine in a 4-dose regimen at 2, 4, 6, and 12 months of age. Duration of treatment is 11 months.

    Reporting group title
    COMVAX™ Vaccine
    Reporting group description
    COMVAX™ vaccine HBsAg and PRP in a 3-dose regimen at 2, 4, and 12 months of age. All participants also received Prevnar® vaccine in a 4-dose regimen at 2, 4, 6, and 12 months of age. Duration of treatment is 11 months.

    Subject analysis set title
    Modified Process Vaccine - Per Protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.

    Subject analysis set title
    COMVAX™ Vaccine - Per Protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.

    Subject analysis set title
    Modified Process Vaccine - Safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine.

    Subject analysis set title
    COMVAX™ - Safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine.

    Primary: Percentage of Anti-Hepatitis B Seroprotected Participants One Month after the Third Dose

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    End point title
    Percentage of Anti-Hepatitis B Seroprotected Participants One Month after the Third Dose [1]
    End point description
    The percentage of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 milli International Units [mIU] /mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose). An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.
    End point type
    Primary
    End point timeframe
    One month after dose 3 (11 months)
    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: No between-group statistical analyses were conducted for this endpoint
    End point values
    Modified Process Vaccine - Per Protocol COMVAX™ Vaccine - Per Protocol
    Number of subjects analysed
    230
    228
    Units: Percentage of participants
        number (confidence interval 95%)
    100 (98.7 to 100)
    99.1 (96.9 to 99.9)
    No statistical analyses for this end point

    Primary: Geometric Mean Titer of Anti-Hepatitis B Antibodies One Month after the Third Dose

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    End point title
    Geometric Mean Titer of Anti-Hepatitis B Antibodies One Month after the Third Dose
    End point description
    Geometric Mean Titer (GMT in milli International units [mIU]/mL) – This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).
    End point type
    Primary
    End point timeframe
    One month after dose 3 (11 months)
    End point values
    Modified Process Vaccine - Per Protocol COMVAX™ Vaccine - Per Protocol
    Number of subjects analysed
    230
    228
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    4204.4 (3411.2 to 5182)
    1683.4 (1350.4 to 2098.6)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Modified Process Vaccine - Per Protocol v COMVAX™ Vaccine - Per Protocol
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    GMT Ratio (Modified / COMVAX)
    Point estimate
    2.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.9
         upper limit
    3.3
    Notes
    [2] - The Modified Process Vaccine is non-inferior to COMVAX with respect to anti-HBs GMT. The non-inferiority criterion requires that the lower bound of the two-sided 95% confidence interval on the ratio of the Month 11 GMTs [GMT modified process vaccine/GMT COMVAX™] is >0.67.

    Secondary: Number of Participants with Serious Vaccine-related Clinical Adverse Experiences

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    End point title
    Number of Participants with Serious Vaccine-related Clinical Adverse Experiences
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 11 months (recorded from the first dose until completion or discontinuation)
    End point values
    Modified Process Vaccine - Safety COMVAX™ - Safety
    Number of subjects analysed
    269
    273
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Anti-PRP Seroprotected Participants One Month after the Third Dose

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    End point title
    Percentage of Anti-PRP Seroprotected Participants One Month after the Third Dose
    End point description
    The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose).
    End point type
    Secondary
    End point timeframe
    One month after dose 3 (11 months)
    End point values
    Modified Process Vaccine - Per Protocol COMVAX™ Vaccine - Per Protocol
    Number of subjects analysed
    230
    228
    Units: Percentage of participants
        number (confidence interval 95%)
    93.9 (90 to 96.6)
    92.1 (87.8 to 95.3)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer of Anti-PRP Antibodies One Month after the Third Dose

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    End point title
    Geometric Mean Titer of Anti-PRP Antibodies One Month after the Third Dose
    End point description
    Geometric Mean Titer (GMT) – This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose).
    End point type
    Secondary
    End point timeframe
    One month after dose 3 (11 months)
    End point values
    Modified Process Vaccine - Per Protocol COMVAX™ Vaccine - Per Protocol
    Number of subjects analysed
    230
    228
    Units: µg/mL
        geometric mean (confidence interval 95%)
    7.1 (6 to 8.4)
    8 (6.7 to 9.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Systemic adverse events: Day 1 - 15 after any vaccination; injection-site adverse events: Day 1 - 5 after any vaccination
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Modified Process Vaccine - Safety
    Reporting group description
    The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and had safety follow-up.

    Reporting group title
    COMVAX™ - Safety
    Reporting group description
    The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and had safety follow-up.

    Serious adverse events
    Modified Process Vaccine - Safety COMVAX™ - Safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 269 (0.00%)
    3 / 273 (1.10%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Medication error
         subjects affected / exposed
    0 / 269 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 269 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 269 (0.00%)
    1 / 273 (0.37%)
         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: 1%
    Non-serious adverse events
    Modified Process Vaccine - Safety COMVAX™ - Safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    259 / 269 (96.28%)
    264 / 273 (96.70%)
    Investigations
    Body temperature increased
         subjects affected / exposed
    6 / 269 (2.23%)
    8 / 273 (2.93%)
         occurrences all number
    6
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 269 (3.35%)
    21 / 273 (7.69%)
         occurrences all number
    11
    21
    Nasal congestion
         subjects affected / exposed
    6 / 269 (2.23%)
    8 / 273 (2.93%)
         occurrences all number
    6
    9
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    27 / 269 (10.04%)
    31 / 273 (11.36%)
         occurrences all number
    37
    37
    Poor quality sleep
         subjects affected / exposed
    4 / 269 (1.49%)
    3 / 273 (1.10%)
         occurrences all number
    4
    3
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    6 / 269 (2.23%)
    8 / 273 (2.93%)
         occurrences all number
    6
    8
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    19 / 269 (7.06%)
    15 / 273 (5.49%)
         occurrences all number
    19
    17
    Injection site bruising
         subjects affected / exposed
    9 / 269 (3.35%)
    9 / 273 (3.30%)
         occurrences all number
    9
    10
    Injection site erythema
         subjects affected / exposed
    174 / 269 (64.68%)
    179 / 273 (65.57%)
         occurrences all number
    309
    308
    Injection site induration
         subjects affected / exposed
    33 / 269 (12.27%)
    31 / 273 (11.36%)
         occurrences all number
    53
    42
    Injection site pain
         subjects affected / exposed
    195 / 269 (72.49%)
    213 / 273 (78.02%)
         occurrences all number
    379
    408
    Injection site swelling
         subjects affected / exposed
    164 / 269 (60.97%)
    146 / 273 (53.48%)
         occurrences all number
    268
    247
    Irritability
         subjects affected / exposed
    117 / 269 (43.49%)
    131 / 273 (47.99%)
         occurrences all number
    195
    228
    Pyrexia
         subjects affected / exposed
    162 / 269 (60.22%)
    167 / 273 (61.17%)
         occurrences all number
    255
    287
    Injection site nodule
         subjects affected / exposed
    6 / 269 (2.23%)
    6 / 273 (2.20%)
         occurrences all number
    7
    7
    Injection site haematoma
         subjects affected / exposed
    3 / 269 (1.12%)
    1 / 273 (0.37%)
         occurrences all number
    3
    1
    Psychiatric disorders
    Crying
         subjects affected / exposed
    58 / 269 (21.56%)
    63 / 273 (23.08%)
         occurrences all number
    95
    92
    Restlessness
         subjects affected / exposed
    4 / 269 (1.49%)
    15 / 273 (5.49%)
         occurrences all number
    4
    19
    Insomnia
         subjects affected / exposed
    6 / 269 (2.23%)
    4 / 273 (1.47%)
         occurrences all number
    6
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    24 / 269 (8.92%)
    26 / 273 (9.52%)
         occurrences all number
    31
    32
    Flatulence
         subjects affected / exposed
    8 / 269 (2.97%)
    14 / 273 (5.13%)
         occurrences all number
    11
    16
    Teething
         subjects affected / exposed
    10 / 269 (3.72%)
    17 / 273 (6.23%)
         occurrences all number
    10
    19
    Vomiting
         subjects affected / exposed
    10 / 269 (3.72%)
    15 / 273 (5.49%)
         occurrences all number
    14
    15
    Abdominal pain upper
         subjects affected / exposed
    6 / 269 (2.23%)
    6 / 273 (2.20%)
         occurrences all number
    6
    7
    Constipation
         subjects affected / exposed
    4 / 269 (1.49%)
    6 / 273 (2.20%)
         occurrences all number
    4
    6
    Regurgitation
         subjects affected / exposed
    6 / 269 (2.23%)
    11 / 273 (4.03%)
         occurrences all number
    7
    11
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    14 / 269 (5.20%)
    10 / 273 (3.66%)
         occurrences all number
    16
    12
    Dermatitis diaper
         subjects affected / exposed
    5 / 269 (1.86%)
    4 / 273 (1.47%)
         occurrences all number
    7
    4
    Eczema
         subjects affected / exposed
    3 / 269 (1.12%)
    2 / 273 (0.73%)
         occurrences all number
    3
    2
    Erythema
         subjects affected / exposed
    1 / 269 (0.37%)
    4 / 273 (1.47%)
         occurrences all number
    1
    4
    Urticaria
         subjects affected / exposed
    3 / 269 (1.12%)
    1 / 273 (0.37%)
         occurrences all number
    3
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    14 / 269 (5.20%)
    10 / 273 (3.66%)
         occurrences all number
    17
    10
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    25 / 269 (9.29%)
    31 / 273 (11.36%)
         occurrences all number
    26
    38
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 269 (5.95%)
    13 / 273 (4.76%)
         occurrences all number
    17
    13
    Ear infection
         subjects affected / exposed
    5 / 269 (1.86%)
    3 / 273 (1.10%)
         occurrences all number
    5
    3
    Exanthema subitum
         subjects affected / exposed
    3 / 269 (1.12%)
    0 / 273 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis
         subjects affected / exposed
    3 / 269 (1.12%)
    3 / 273 (1.10%)
         occurrences all number
    4
    3
    Influenza
         subjects affected / exposed
    8 / 269 (2.97%)
    9 / 273 (3.30%)
         occurrences all number
    8
    9
    Laryngitis
         subjects affected / exposed
    0 / 269 (0.00%)
    4 / 273 (1.47%)
         occurrences all number
    0
    4
    Nasopharyngitis
         subjects affected / exposed
    8 / 269 (2.97%)
    11 / 273 (4.03%)
         occurrences all number
    9
    11
    Otitis media
         subjects affected / exposed
    12 / 269 (4.46%)
    12 / 273 (4.40%)
         occurrences all number
    12
    13
    Respiratory tract infection
         subjects affected / exposed
    3 / 269 (1.12%)
    2 / 273 (0.73%)
         occurrences all number
    3
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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