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    Clinical Trial Results:
    A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age

    Summary
    EudraCT number
    		 2006-001638-42
    Trial protocol
    		 NO   FI  
    Global end of trial date
    24 Oct 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Feb 2017
    First version publication date
    03 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V232-057
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00414050
    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
    24 Oct 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to demonstrate that at 1 month after the third dose of vaccine, either the modified process hepatitis B vaccine at 5 μg or RECOMBIVAX HB™ will induce adequate seroprotection rates (SPR).
    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 Oct 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: 1688
    Country: Number of subjects enrolled
    Norway: 30
    Worldwide total number of subjects
    1718
    EEA total number of subjects
    1718
    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)
    1718
    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
    		 15-Nov-2006 (first participant enrolled in study) to 24-Oct-2007 (last participant had their last visit). Last participant completed follow-up: 16-Oct-2007. This study was conducted at 15 sites; 14 in Finland and 1 in Norway.

    Pre-assignment
    Screening details
    		 Participants include healthy infants approximately 2 months of age.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Modified Process Hepatitis B vaccine 5 µg
    Arm description
    		 Infants received a primary series of 3 doses of experimental vaccine (5 µg per dose) at 2, 4 and 6 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Modified Process Hepatitis B vaccine
    Investigational medicinal product code
    Other name
    V232
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    5 µg/0.5mL IM injection

    Arm title
    		 RECOMBIVAX™ Hepatitis B Vaccine
    Arm description
    		 Infants received a primary series of 3 doses of currently licensed vaccine (5 µg per dose) at 2, 4 and 6 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hepatitis B Vaccine (Recombinant)
    Investigational medicinal product code
    Other name
    RECOMBIVAX HB™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    5 µg/0.5mL IM injection

    Arm title
    		 Modified Process Hepatitis B vaccine 10 µg
    Arm description
    		 Infants received a primary series of 3 doses of experimental vaccine (10 µg per dose) at 2, 4 and 6 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Modified Process Hepatitis B vaccine
    Investigational medicinal product code
    Other name
    V232
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 µg/0.5mL IM injection

    Arm title
    		 ENGERIX-B™
    Arm description
    		 Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hepatitis B Vaccine (Recombinant)
    Investigational medicinal product code
    Other name
    ENGERIX-B™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 µg/0.5mL IM injection

    Number of subjects in period 1
    		Modified Process Hepatitis B vaccine 5 µg RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B vaccine 10 µg ENGERIX-B™
    Started
    431
    427
    429
    431
    Received Vaccination 1
    431
    426
    429
    431
    Received Vaccination 2
    425
    421
    425
    425
    Received Vaccination 3
    424
    419
    425
    424
    Completed
    422
    419
    423
    423
    Not completed
    9
    8
    6
    8
         Adverse event, serious fatal
    -
    1
    -
    -
         Consent withdrawn by subject
    5
    3
    2
    4
         Adverse event, non-fatal
    1
    -
    1
    1
         Subject discontinued for other reason
    1
    2
    2
    1
         Lost to follow-up
    2
    2
    1
    1
         Subject Moved
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Modified Process Hepatitis B vaccine 5 µg
    Reporting group description
    		 Infants received a primary series of 3 doses of experimental vaccine (5 µg per dose) at 2, 4 and 6 months of age.

    Reporting group title
    RECOMBIVAX™ Hepatitis B Vaccine
    Reporting group description
    		 Infants received a primary series of 3 doses of currently licensed vaccine (5 µg per dose) at 2, 4 and 6 months of age.

    Reporting group title
    Modified Process Hepatitis B vaccine 10 µg
    Reporting group description
    		 Infants received a primary series of 3 doses of experimental vaccine (10 µg per dose) at 2, 4 and 6 months of age.

    Reporting group title
    ENGERIX-B™
    Reporting group description
    		 Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.

    Reporting group values
    		 Modified Process Hepatitis B vaccine 5 µg RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B vaccine 10 µg ENGERIX-B™ Total
    Number of subjects
    		 431 427 429 431 1718
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: days
        arithmetic mean (standard deviation)
    		 63.2 ( 10.18 ) 62.9 ( 10.15 ) 63.3 ( 9.83 ) 62.8 ( 9.81 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 190 217 208 201 816
        Male
    		 241 210 221 230 902

    End points

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    End points reporting groups
    Reporting group title
    Modified Process Hepatitis B vaccine 5 µg
    Reporting group description
    		 Infants received a primary series of 3 doses of experimental vaccine (5 µg per dose) at 2, 4 and 6 months of age.

    Reporting group title
    RECOMBIVAX™ Hepatitis B Vaccine
    Reporting group description
    		 Infants received a primary series of 3 doses of currently licensed vaccine (5 µg per dose) at 2, 4 and 6 months of age.

    Reporting group title
    Modified Process Hepatitis B vaccine 10 µg
    Reporting group description
    		 Infants received a primary series of 3 doses of experimental vaccine (10 µg per dose) at 2, 4 and 6 months of age.

    Reporting group title
    ENGERIX-B™
    Reporting group description
    		 Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.

    Primary: The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 µg and 10 µg dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B

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    End point title
    		 The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 µg and 10 µg dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B [1]
    End point description
    The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 µg vaccine or RECOMBIVAX HB. Specifically, the lower bound of the multiplicity adjusted 95% CI on the seroprotection rate for either vaccine was required to be above 90.0%. Analysis population: per-protocol population is defined as the participants able to complete the study as defined by the protocol.
    End point type
    Primary
    End point timeframe
    7 months of age (1 month after 3 doses)
    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 planned or performed for this endpoint.
    End point values
    		 Modified Process Hepatitis B vaccine 5 µg RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B vaccine 10 µg ENGERIX-B™
    Number of subjects analysed
    405
    406
    398
    400
    Units: Percentage of participants
        number (confidence interval 95%)
    99.3 (98.3 to 100)
    98.5 (97.2 to 99.8)
    100 (99.9 to 100)
    99.5 (98.7 to 100)
    No statistical analyses for this end point

    Secondary: Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (anti-HBs GMT) Responses for Modified Process Vaccine (5 µg and 10 µg), RECOMBIVAX Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B

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    End point title
    		 Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (anti-HBs GMT) Responses for Modified Process Vaccine (5 µg and 10 µg), RECOMBIVAX Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B
    End point description
    Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood. Analysis population: per-protocol population is defined as the participants able to complete the study as defined by the protocol.
    End point type
    Secondary
    End point timeframe
    7 months of age (1 month after 3 doses)
    End point values
    		 Modified Process Hepatitis B vaccine 5 µg RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B vaccine 10 µg ENGERIX-B™
    Number of subjects analysed
    405
    406
    398
    400
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    748.2 (672 to 833.1)
    376.8 (331.4 to 428.5)
    981.5 (891 to 1081.2)
    556.6 (491.8 to 629.9)
    Statistical analysis title
    		 Non-inferiority of Geometric Mean Titers Ratio
    Statistical analysis description
    Comparison of Induced (effected) Geometric Mean Titer for the Modified Hepatitis B Process Vaccine and RECOMBIVAX Hepatitis B vaccine.
    Comparison groups
    Modified Process Hepatitis B vaccine 5 µg v RECOMBIVAX™ Hepatitis B Vaccine
    Number of subjects included in analysis
    811
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.69
         upper limit
    		 2.35
    Notes
    [2] - Modified Process Hepatitis B vaccine-5 µg declared non-inferior to RECOMBIVAX HB™ if the lower bound of the 95% Confidence Interval for the ratio of Geometric Mean Titers (Modified Process Vaccine 5 µg/RECOMBIVAX HB™) was >= 0.67. The study had 98 percent power for this test, based on an assumption of true equality.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination
    Adverse event reporting additional description
    All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B participant who received 2 doses of ENGERIX-B and 1 dose of RECOMBIVAX HB.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Modified Process Hepatitis B vaccine, 5 µg (micrograms)
    Reporting group description
    		 Infants received a primary series of 3 doses of experimental vaccine (5 µg per dose) at 2, 4 and 6 months of age.

    Reporting group title
    RECOMBIVAX™ Hepatitis B Vaccine
    Reporting group description
    		 Infants received a primary series of 3 doses of currently licensed vaccine (5 µg per dose) at 2, 4 and 6 months of age. Population also includes 1 participant randomized to ENGERIX-B but inadvertently received 1 dose of RECOMBIVAX HB.

    Reporting group title
    Modified Process Hepatitis B vaccine 10 µg (micrograms)
    Reporting group description
    		 Infants received a primary series of 3 doses of experimental vaccine (10 µg per dose) at 2, 4 and 6 months of age. Population also includes 1 participant randomized to ENGERIX-B but inadvertently received 1 dose of modified process hepatitis B vaccine 10 μg.

    Reporting group title
    ENGERIX-B
    Reporting group description
    		 Infants received a primary series of 3 doses of currently licensed vaccine (10 µg per dose) at 2, 4 and 6 months of age.

    Serious adverse events
    		 Modified Process Hepatitis B vaccine, 5 µg (micrograms) RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B vaccine 10 µg (micrograms) ENGERIX-B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 430 (2.56%)
    2 / 424 (0.47%)
    6 / 429 (1.40%)
    8 / 428 (1.87%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Nutritional condition abnormal
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 430 (0.00%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    1 / 428 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden infant death syndrome
         subjects affected / exposed
    0 / 430 (0.00%)
    1 / 424 (0.24%)
    0 / 429 (0.00%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Epididymitis
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 430 (0.00%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    1 / 428 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 430 (0.00%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    1 / 428 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    0 / 430 (0.00%)
    0 / 424 (0.00%)
    1 / 429 (0.23%)
    1 / 428 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Crying
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 430 (0.00%)
    0 / 424 (0.00%)
    2 / 429 (0.47%)
    1 / 428 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    1 / 429 (0.23%)
    2 / 428 (0.47%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 430 (0.00%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    1 / 428 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    2 / 430 (0.47%)
    0 / 424 (0.00%)
    1 / 429 (0.23%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 430 (0.00%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    1 / 428 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    2 / 429 (0.47%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 430 (0.23%)
    1 / 424 (0.24%)
    0 / 429 (0.00%)
    1 / 428 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    1 / 428 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    1 / 430 (0.23%)
    0 / 424 (0.00%)
    0 / 429 (0.00%)
    0 / 428 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Modified Process Hepatitis B vaccine, 5 µg (micrograms) RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B vaccine 10 µg (micrograms) ENGERIX-B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    308 / 430 (71.63%)
    294 / 424 (69.34%)
    276 / 429 (64.34%)
    288 / 428 (67.29%)
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    114 / 430 (26.51%)
    109 / 424 (25.71%)
    91 / 429 (21.21%)
    107 / 428 (25.00%)
         occurrences all number
    169
    157
    138
    139
    Pyrexia
         subjects affected / exposed
    62 / 430 (14.42%)
    57 / 424 (13.44%)
    56 / 429 (13.05%)
    53 / 428 (12.38%)
         occurrences all number
    78
    65
    68
    65
    Injection-site erythema
         subjects affected / exposed
    128 / 430 (29.77%)
    117 / 424 (27.59%)
    116 / 429 (27.04%)
    94 / 428 (21.96%)
         occurrences all number
    169
    160
    153
    124
    Injection-site induration
         subjects affected / exposed
    25 / 430 (5.81%)
    15 / 424 (3.54%)
    24 / 429 (5.59%)
    8 / 428 (1.87%)
         occurrences all number
    29
    19
    26
    9
    Injection-site pain
         subjects affected / exposed
    79 / 430 (18.37%)
    73 / 424 (17.22%)
    60 / 429 (13.99%)
    66 / 428 (15.42%)
         occurrences all number
    117
    96
    90
    92
    Injection-site swelling
         subjects affected / exposed
    78 / 430 (18.14%)
    85 / 424 (20.05%)
    87 / 429 (20.28%)
    65 / 428 (15.19%)
         occurrences all number
    109
    111
    110
    98
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    9 / 430 (2.09%)
    14 / 424 (3.30%)
    10 / 429 (2.33%)
    22 / 428 (5.14%)
         occurrences all number
    11
    14
    10
    23
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    30 / 430 (6.98%)
    26 / 424 (6.13%)
    26 / 429 (6.06%)
    18 / 428 (4.21%)
         occurrences all number
    37
    36
    31
    26
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    21 / 430 (4.88%)
    15 / 424 (3.54%)
    17 / 429 (3.96%)
    25 / 428 (5.84%)
         occurrences all number
    21
    18
    19
    26
    Psychiatric disorders
    Crying
         subjects affected / exposed
    41 / 430 (9.53%)
    39 / 424 (9.20%)
    39 / 429 (9.09%)
    41 / 428 (9.58%)
         occurrences all number
    51
    49
    48
    48
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    53 / 430 (12.33%)
    47 / 424 (11.08%)
    59 / 429 (13.75%)
    51 / 428 (11.92%)
         occurrences all number
    57
    54
    68
    57
    Upper respiratory tract infection
         subjects affected / exposed
    32 / 430 (7.44%)
    26 / 424 (6.13%)
    25 / 429 (5.83%)
    23 / 428 (5.37%)
         occurrences all number
    35
    27
    25
    25

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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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    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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