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    Clinical Trial Results:
    A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO™

    Summary
    EudraCT number
    		 2006-001639-23
    Trial protocol
    		 ES  
    Global end of trial date
    23 Jun 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2017
    First version publication date
    05 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V232-058
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00393523
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Protocol number: V232-058
    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
    23 Jun 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jun 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB™ vaccine or ENGERIX-B™ vaccine. The primary vaccination series was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB™ vaccine or ENGERIX-B™ vaccine). The booster dose given in this study was either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-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
    22 Sep 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
    Canada: 20
    Country: Number of subjects enrolled
    Spain: 1458
    Worldwide total number of subjects
    1478
    EEA total number of subjects
    1458
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    1478
    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
    		 This study was conducted at 77 primary study sites in Spain and 1 study site in Canada. Date of first participant visit: 26-Sep-2006; Date of last participant visit: 23-June-2008

    Pre-assignment
    Screening details
    		 To be eligible for enrollment in the study, participants must have received a primary series of 3 doses of hepatitis B vaccine (either RECOMBIVAX HB™ vaccine or ENGERIX-B™ vaccine) during the first year of life.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V232 Vaccine Booster (RECOMBIVAX HB™ in infancy) (Group 1)
    Arm description
    		 Participants received a primary series of 3 doses of RECOMBIVAX HB™ vaccine (5 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232, 5 µg (Booster Dose)
    Arm type
    		 Experimental

    Investigational medicinal product name
    V232 Vaccine (Modified Process Hepatitis B Vaccine Booster)
    Investigational medicinal product code
    Other name
    V232
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    5 μg/0.5 mL, intramuscular

    Arm title
    		 ENGERIX-B™ Booster (RECOMBIVAX HB™ in infancy) (Group 2)
    Arm description
    		 Participants received a primary series of 3 doses of RECOMBIVAX HB™ vaccine (5 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of ENGERIX-B™ vaccine (10 µg per dose) (Booster Dose)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ENGERIX-B™ Vaccine Booster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 μg/0.5 mL, intramuscular

    Arm title
    		 V232 Vaccine Booster (ENGERIX-B™ in infancy) (Group 3)
    Arm description
    		 Participants received a primary series of 3 doses of ENGERIX-B™ vaccine (10 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232, 5 µg (Booster Dose)
    Arm type
    		 Experimental

    Investigational medicinal product name
    V232 Vaccine (Modified Process Hepatitis B Vaccine Booster)
    Investigational medicinal product code
    Other name
    V232
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    5 μg/0.5 mL, intramuscular

    Arm title
    		 ENGERIX-B™ Booster (ENGERIX-B™ in infancy) (Group 4)
    Arm description
    		 Participants received a primary series of 3 doses of ENGERIX-B™ vaccine (10 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of ENGERIX-B™ vaccine (10 µg per dose) (Booster Dose)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ENGERIX-B™ Vaccine Booster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 μg/0.5 mL, intramuscular

    Arm title
    		 V232 Vaccine (no prior Hepatitis B vaccine) (Group 5)
    Arm description
    		 Participants did not receive a prior vaccination with a hepatitis B vaccine. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232), 5 µg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V232 Vaccine (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/0.5 mL, intramuscular

    Number of subjects in period 1
    		V232 Vaccine Booster (RECOMBIVAX HB™ in infancy) (Group 1) ENGERIX-B™ Booster (RECOMBIVAX HB™ in infancy) (Group 2) V232 Vaccine Booster (ENGERIX-B™ in infancy) (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in infancy) (Group 4) V232 Vaccine (no prior Hepatitis B vaccine) (Group 5)
    Started
    376
    375
    353
    354
    20
    Vaccination Visit 1
    374
    375
    349
    352
    20
    Completed
    364
    366
    349
    348
    19
    Not completed
    12
    9
    4
    6
    1
         Consent withdrawn by subject
    6
    7
    2
    3
    -
         Difficulties in specimen collection
    -
    -
    1
    -
    -
         Vaccine supply issue
    -
    -
    1
    -
    -
         Lost to follow-up
    -
    -
    -
    2
    1
         Protocol deviation
    6
    2
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V232 Vaccine Booster (RECOMBIVAX HB™ in infancy) (Group 1)
    Reporting group description
    		 Participants received a primary series of 3 doses of RECOMBIVAX HB™ vaccine (5 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232, 5 µg (Booster Dose)

    Reporting group title
    ENGERIX-B™ Booster (RECOMBIVAX HB™ in infancy) (Group 2)
    Reporting group description
    		 Participants received a primary series of 3 doses of RECOMBIVAX HB™ vaccine (5 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of ENGERIX-B™ vaccine (10 µg per dose) (Booster Dose)

    Reporting group title
    V232 Vaccine Booster (ENGERIX-B™ in infancy) (Group 3)
    Reporting group description
    		 Participants received a primary series of 3 doses of ENGERIX-B™ vaccine (10 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232, 5 µg (Booster Dose)

    Reporting group title
    ENGERIX-B™ Booster (ENGERIX-B™ in infancy) (Group 4)
    Reporting group description
    		 Participants received a primary series of 3 doses of ENGERIX-B™ vaccine (10 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of ENGERIX-B™ vaccine (10 µg per dose) (Booster Dose)

    Reporting group title
    V232 Vaccine (no prior Hepatitis B vaccine) (Group 5)
    Reporting group description
    		 Participants did not receive a prior vaccination with a hepatitis B vaccine. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232), 5 µg.

    Reporting group values
    		 V232 Vaccine Booster (RECOMBIVAX HB™ in infancy) (Group 1) ENGERIX-B™ Booster (RECOMBIVAX HB™ in infancy) (Group 2) V232 Vaccine Booster (ENGERIX-B™ in infancy) (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in infancy) (Group 4) V232 Vaccine (no prior Hepatitis B vaccine) (Group 5) Total
    Number of subjects
    		 376 375 353 354 20 1478
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 376 375 353 354 20 1478
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 5.7 ( 0.92 ) 5.7 ( 0.97 ) 5.3 ( 1.05 ) 5.4 ( 0.98 ) 4.3 ( 0.66 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 172 186 179 161 13 711
        Male
    		 204 189 174 193 7 767

    End points

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    End points reporting groups
    Reporting group title
    V232 Vaccine Booster (RECOMBIVAX HB™ in infancy) (Group 1)
    Reporting group description
    		 Participants received a primary series of 3 doses of RECOMBIVAX HB™ vaccine (5 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232, 5 µg (Booster Dose)

    Reporting group title
    ENGERIX-B™ Booster (RECOMBIVAX HB™ in infancy) (Group 2)
    Reporting group description
    		 Participants received a primary series of 3 doses of RECOMBIVAX HB™ vaccine (5 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of ENGERIX-B™ vaccine (10 µg per dose) (Booster Dose)

    Reporting group title
    V232 Vaccine Booster (ENGERIX-B™ in infancy) (Group 3)
    Reporting group description
    		 Participants received a primary series of 3 doses of ENGERIX-B™ vaccine (10 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232, 5 µg (Booster Dose)

    Reporting group title
    ENGERIX-B™ Booster (ENGERIX-B™ in infancy) (Group 4)
    Reporting group description
    		 Participants received a primary series of 3 doses of ENGERIX-B™ vaccine (10 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of ENGERIX-B™ vaccine (10 µg per dose) (Booster Dose)

    Reporting group title
    V232 Vaccine (no prior Hepatitis B vaccine) (Group 5)
    Reporting group description
    		 Participants did not receive a prior vaccination with a hepatitis B vaccine. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232), 5 µg.

    Subject analysis set title
    Modified Process Hepatitis B Vaccine
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a primary series of 3 doses of RECOMBIVAX HB™ vaccine (5 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232, 5 µg (Booster Dose).

    Subject analysis set title
    ENGERIX-B™ Vaccine
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a primary series of 3 doses of RECOMBIVAX HB™ vaccine (5 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of ENGERIX-B™ vaccine (10 µg per dose) (Booster Dose).

    Primary: Participants With an Antibody Response to Hepatitis B Surface Antigen in Participants Who Received a 3-dose Primary Series of RECOMBIVAX HB™ in Infancy

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    End point title
    		 Participants With an Antibody Response to Hepatitis B Surface Antigen in Participants Who Received a 3-dose Primary Series of RECOMBIVAX HB™ in Infancy [1] [2]
    End point description
    Participants who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 1 month after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™. Per protocol population was defined as the participants that completed the study as defined by the protocol. Participants were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
    End point type
    Primary
    End point timeframe
    4 weeks (1 month) after booster dose
    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 statistical analysis was planned or performed for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 V232 Vaccine Booster (RECOMBIVAX HB™ in infancy) (Group 1) ENGERIX-B™ Booster (RECOMBIVAX HB™ in infancy) (Group 2)
    Number of subjects analysed
    340
    333
    Units: Participants
        number (not applicable)
    323
    305
    No statistical analyses for this end point

    Primary: Seroprotection rate (SPR) to Hepatitis B Surface Antigen in Participants Who Received a 3-dose Primary Series of RECOMBIVAX HB™ in Infancy

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    End point title
    		 Seroprotection rate (SPR) to Hepatitis B Surface Antigen in Participants Who Received a 3-dose Primary Series of RECOMBIVAX HB™ in Infancy [3] [4]
    End point description
    Participants received a 3-dose primary series of RECOMBIVAX HB™ in infancy. Seroprotection rate (SPR) was defined as the percentage of participants who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 1 month after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™. The statistical criterion for an adequate SPR required the lower bound of the 2-sided multiplicity adjusted 95.2% confidence interval for the anti-HBs SPR 4 weeks after the booster dose for participants to be greater than 90%. Per protocol population was defined as the participants that completed the study as defined by the protocol. Participants were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
    End point type
    Primary
    End point timeframe
    4 weeks (1 month) after booster dose
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed for this endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 V232 Vaccine Booster (RECOMBIVAX HB™ in infancy) (Group 1) ENGERIX-B™ Booster (RECOMBIVAX HB™ in infancy) (Group 2)
    Number of subjects analysed
    340
    333
    Units: Percentage of participants
        number (confidence interval 95%)
    95 (92.1 to 97.1)
    91.6 (88.1 to 94.3)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Experienced One or More Adverse Events (AEs)

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    End point title
    		 Percentage of Participants Who Experienced One or More Adverse Events (AEs) [5]
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The safety population consisted of all participants who received at least one dose of Modified Process Hepatitis B Vaccine or ENGERIX-B™.
    End point type
    Primary
    End point timeframe
    Up to 14 days following booster vaccination with modified process hepatitis B vaccine or ENGERIX-B™ vaccine
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 Modified Process Hepatitis B Vaccine ENGERIX-B™ Vaccine
    Number of subjects analysed
    742
    717
    Units: Percentage of participants
        number (not applicable)
    58
    55.9
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Discontinued the Study Due to an AE

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    End point title
    		 Percentage of Participants Who Discontinued the Study Due to an AE [6]
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The safety population consisted of all participants who received at least one dose of Modified Process Hepatitis B Vaccine or ENGERIX-B™.
    End point type
    Primary
    End point timeframe
    Up to 14 days following booster vaccination with modified process hepatitis B vaccine or ENGERIX-B™ vaccine
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 Modified Process Hepatitis B Vaccine ENGERIX-B™ Vaccine
    Number of subjects analysed
    742
    717
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Participants With an Antibody Response to Hepatitis B Surface Antigen in Participants Who Received a 3-Dose Primary Series of ENGERIX-B™ in Infancy

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    End point title
    		 Participants With an Antibody Response to Hepatitis B Surface Antigen in Participants Who Received a 3-Dose Primary Series of ENGERIX-B™ in Infancy [7]
    End point description
    Participants who received a 3-dose primary series of ENGERIX™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 1 month after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™. Per protocol population was defined as the participants that completed the study as defined by the protocol. Participants were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
    End point type
    Secondary
    End point timeframe
    4 weeks (1 month) after booster dose
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 V232 Vaccine Booster (ENGERIX-B™ in infancy) (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in infancy) (Group 4)
    Number of subjects analysed
    338
    328
    Units: Participants
        number (not applicable)
    329
    313
    No statistical analyses for this end point

    Secondary: SPR to Hepatitis B Surface Antigen in Participants Who Received a 3-Dose Primary Series of ENGERIX-B™ in Infancy

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    End point title
    		 SPR to Hepatitis B Surface Antigen in Participants Who Received a 3-Dose Primary Series of ENGERIX-B™ in Infancy [8]
    End point description
    Participants received a 3-dose primary series of ENGERIX™ in infancy. SPR was defined as the percentage of participants who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 1 month after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™. The statistical criterion for an adequate SPR required the lower bound of the 2-sided multiplicity adjusted 95.2% confidence interval for the anti-HBs SPR 4 weeks after the booster dose for participants to be greater than 90%. Per protocol population was defined as the participants that completed the study as defined by the protocol. Participants were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
    End point type
    Secondary
    End point timeframe
    4 weeks (1 month) after booster dose
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 V232 Vaccine Booster (ENGERIX-B™ in infancy) (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in infancy) (Group 4)
    Number of subjects analysed
    338
    328
    Units: Percentage of participants
        number (confidence interval 95%)
    97.3 (95 to 98.8)
    95.4 (92.6 to 97.4)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titer (GMT) for Antibodies to Hepatitis B Surface Antigen in Participants Who Received a 3-Dose Primary Series of RECOMBIVAX HB™ in Infancy

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    End point title
    		 Geometric Mean Titer (GMT) for Antibodies to Hepatitis B Surface Antigen in Participants Who Received a 3-Dose Primary Series of RECOMBIVAX HB™ in Infancy [9]
    End point description
    GMT (in milli-international units per milliliter [mIU/mL]) for all participants who completed a 3-dose primary vaccination series of RECOMBIVAX HB™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™. Per protocol population was defined as the participants that completed the study as defined by the protocol. Participants were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
    End point type
    Other pre-specified
    End point timeframe
    4 weeks (1 month) after booster dose
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 V232 Vaccine Booster (RECOMBIVAX HB™ in infancy) (Group 1) ENGERIX-B™ Booster (RECOMBIVAX HB™ in infancy) (Group 2)
    Number of subjects analysed
    340
    333
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    476.9 (380.7 to 597.3)
    561.2 (435.6 to 723.1)
    No statistical analyses for this end point

    Other pre-specified: GMT for Antibodies to Hepatitis B Surface Antigen in Participants Who Received a 3-Dose Primary Series of ENGERIX-B™ in Infancy

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    End point title
    		 GMT for Antibodies to Hepatitis B Surface Antigen in Participants Who Received a 3-Dose Primary Series of ENGERIX-B™ in Infancy [10]
    End point description
    GMT for all participants who completed a 3-dose primary vaccination series of ENGERIX-B™ and who received a booster dose of modified process hepatitis B vaccine or ENGERIX-B™. Per protocol population was defined as the participants that completed the study as defined by the protocol. Participants were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
    End point type
    Other pre-specified
    End point timeframe
    4 weeks (1 month) after booster dose
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 V232 Vaccine Booster (ENGERIX-B™ in infancy) (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in infancy) (Group 4)
    Number of subjects analysed
    338
    328
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    1424 (1131.1 to 1792.8)
    1216.1 (923.6 to 1601.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 32 days following booster vaccination with modified process hepatitis B vaccine or ENGERIX-B™ vaccine
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    ENGERIX-B™ Vaccine
    Reporting group description
    		 Participants received a primary series of 3 doses of RECOMBIVAX HB™ vaccine (5 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of ENGERIX-B™ vaccine (10 µg per dose) (Booster Dose).

    Reporting group title
    Modified Process Hepatitis B Vaccine
    Reporting group description
    		 Participants received a primary series of 3 doses of RECOMBIVAX HB™ vaccine (5 µg per dose) during the first year of life outside of the context of the study. On Day 1 of the study, participants received one dose of Modified Process Hepatitis B Vaccine (V232, 5 µg (Booster Dose).

    Serious adverse events
    		 ENGERIX-B™ Vaccine Modified Process Hepatitis B Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Tonsillitis
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ENGERIX-B™ Vaccine Modified Process Hepatitis B Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    401 / 717 (55.93%)
    430 / 742 (57.95%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 717 (0.14%)
    1 / 742 (0.13%)
         occurrences all number
    1
    1
    Pallor
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Discomfort
         subjects affected / exposed
    2 / 717 (0.28%)
    4 / 742 (0.54%)
         occurrences all number
    2
    4
    Injection site erythema
         subjects affected / exposed
    64 / 717 (8.93%)
    70 / 742 (9.43%)
         occurrences all number
    64
    71
    Injection site bruising
         subjects affected / exposed
    2 / 717 (0.28%)
    2 / 742 (0.27%)
         occurrences all number
    2
    2
    Hypothermia
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    5 / 717 (0.70%)
    4 / 742 (0.54%)
         occurrences all number
    5
    4
    Injection site haematoma
         subjects affected / exposed
    6 / 717 (0.84%)
    3 / 742 (0.40%)
         occurrences all number
    6
    3
    Injection site hypersensitivity
         subjects affected / exposed
    5 / 717 (0.70%)
    4 / 742 (0.54%)
         occurrences all number
    5
    4
    Injection site induration
         subjects affected / exposed
    3 / 717 (0.42%)
    4 / 742 (0.54%)
         occurrences all number
    3
    4
    Injection site oedema
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Injection site pain
         subjects affected / exposed
    207 / 717 (28.87%)
    231 / 742 (31.13%)
         occurrences all number
    208
    241
    Injection site pruritus
         subjects affected / exposed
    7 / 717 (0.98%)
    9 / 742 (1.21%)
         occurrences all number
    7
    9
    Injection site paraesthesia
         subjects affected / exposed
    1 / 717 (0.14%)
    1 / 742 (0.13%)
         occurrences all number
    1
    1
    Injection site scar
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Injection site vesicles
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Injection site swelling
         subjects affected / exposed
    66 / 717 (9.21%)
    98 / 742 (13.21%)
         occurrences all number
    66
    99
    Injection site warmth
         subjects affected / exposed
    0 / 717 (0.00%)
    3 / 742 (0.40%)
         occurrences all number
    0
    3
    Malaise
         subjects affected / exposed
    2 / 717 (0.28%)
    4 / 742 (0.54%)
         occurrences all number
    2
    5
    Irritability
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    1 / 717 (0.14%)
    2 / 742 (0.27%)
         occurrences all number
    1
    3
    Vessel puncture site pain
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    53 / 717 (7.39%)
    42 / 742 (5.66%)
         occurrences all number
    55
    46
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Balanitis
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    5 / 717 (0.70%)
    4 / 742 (0.54%)
         occurrences all number
    6
    4
    Cough
         subjects affected / exposed
    23 / 717 (3.21%)
    36 / 742 (4.85%)
         occurrences all number
    24
    38
    Epistaxis
         subjects affected / exposed
    2 / 717 (0.28%)
    3 / 742 (0.40%)
         occurrences all number
    3
    3
    Dysphonia
         subjects affected / exposed
    1 / 717 (0.14%)
    1 / 742 (0.13%)
         occurrences all number
    1
    1
    Increased upper airway secretion
         subjects affected / exposed
    5 / 717 (0.70%)
    4 / 742 (0.54%)
         occurrences all number
    5
    4
    Nasal oedema
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    4 / 717 (0.56%)
    3 / 742 (0.40%)
         occurrences all number
    4
    3
    Pharyngolaryngeal pain
         subjects affected / exposed
    12 / 717 (1.67%)
    16 / 742 (2.16%)
         occurrences all number
    13
    16
    Rhinalgia
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    3 / 717 (0.42%)
    1 / 742 (0.13%)
         occurrences all number
    3
    1
    Rhinitis seasonal
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 717 (0.28%)
    0 / 742 (0.00%)
         occurrences all number
    2
    0
    Nightmare
         subjects affected / exposed
    1 / 717 (0.14%)
    2 / 742 (0.27%)
         occurrences all number
    1
    3
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 717 (0.14%)
    2 / 742 (0.27%)
         occurrences all number
    1
    2
    Arthropod sting
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Chillblains
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Bite
         subjects affected / exposed
    2 / 717 (0.28%)
    1 / 742 (0.13%)
         occurrences all number
    2
    1
    Excoriation
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    2 / 717 (0.28%)
    4 / 742 (0.54%)
         occurrences all number
    2
    4
    Face injury
         subjects affected / exposed
    1 / 717 (0.14%)
    1 / 742 (0.13%)
         occurrences all number
    1
    1
    Head injury
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Open wound
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Joint sprain
         subjects affected / exposed
    1 / 717 (0.14%)
    2 / 742 (0.27%)
         occurrences all number
    1
    2
    Wound
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    32 / 717 (4.46%)
    35 / 742 (4.72%)
         occurrences all number
    38
    38
    Aphonia
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    2 / 717 (0.28%)
    2 / 742 (0.27%)
         occurrences all number
    2
    2
    Ear and labyrinth disorders
    Motion sickness
         subjects affected / exposed
    1 / 717 (0.14%)
    2 / 742 (0.27%)
         occurrences all number
    1
    2
    Ear pain
         subjects affected / exposed
    10 / 717 (1.39%)
    12 / 742 (1.62%)
         occurrences all number
    10
    12
    Otorrhoea
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 717 (0.42%)
    4 / 742 (0.54%)
         occurrences all number
    3
    4
    Eye discharge
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 717 (0.28%)
    3 / 742 (0.40%)
         occurrences all number
    2
    3
    Eye swelling
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    4 / 717 (0.56%)
    6 / 742 (0.81%)
         occurrences all number
    4
    8
    Abdominal pain
         subjects affected / exposed
    16 / 717 (2.23%)
    8 / 742 (1.08%)
         occurrences all number
    17
    8
    Aphthous stomatitis
         subjects affected / exposed
    3 / 717 (0.42%)
    1 / 742 (0.13%)
         occurrences all number
    3
    1
    Constipation
         subjects affected / exposed
    1 / 717 (0.14%)
    1 / 742 (0.13%)
         occurrences all number
    1
    1
    Dental caries
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    10 / 717 (1.39%)
    17 / 742 (2.29%)
         occurrences all number
    11
    18
    Flatulence
         subjects affected / exposed
    1 / 717 (0.14%)
    1 / 742 (0.13%)
         occurrences all number
    1
    1
    Gastritis
         subjects affected / exposed
    2 / 717 (0.28%)
    1 / 742 (0.13%)
         occurrences all number
    2
    1
    Lip dry
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Lip haemorrhage
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Lip swelling
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 717 (0.28%)
    2 / 742 (0.27%)
         occurrences all number
    2
    2
    Stomatitis
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Odynophagia
         subjects affected / exposed
    1 / 717 (0.14%)
    2 / 742 (0.27%)
         occurrences all number
    1
    2
    Toothache
         subjects affected / exposed
    1 / 717 (0.14%)
    4 / 742 (0.54%)
         occurrences all number
    2
    4
    Vomiting
         subjects affected / exposed
    14 / 717 (1.95%)
    21 / 742 (2.83%)
         occurrences all number
    14
    24
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    3 / 717 (0.42%)
    0 / 742 (0.00%)
         occurrences all number
    3
    0
    Dermatitis
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    8 / 717 (1.12%)
    6 / 742 (0.81%)
         occurrences all number
    8
    6
    Dermatitis contact
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    0 / 717 (0.00%)
    2 / 742 (0.27%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    2 / 717 (0.28%)
    2 / 742 (0.27%)
         occurrences all number
    2
    2
    Rash
         subjects affected / exposed
    2 / 717 (0.28%)
    4 / 742 (0.54%)
         occurrences all number
    3
    4
    Pruritus
         subjects affected / exposed
    2 / 717 (0.28%)
    0 / 742 (0.00%)
         occurrences all number
    2
    0
    Prurigo
         subjects affected / exposed
    2 / 717 (0.28%)
    0 / 742 (0.00%)
         occurrences all number
    2
    0
    Urticaria
         subjects affected / exposed
    2 / 717 (0.28%)
    2 / 742 (0.27%)
         occurrences all number
    2
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 717 (0.28%)
    6 / 742 (0.81%)
         occurrences all number
    3
    7
    Bone pain
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Epiphysiolysis
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 717 (0.00%)
    9 / 742 (1.21%)
         occurrences all number
    0
    9
    Neck pain
         subjects affected / exposed
    3 / 717 (0.42%)
    1 / 742 (0.13%)
         occurrences all number
    3
    1
    Myalgia
         subjects affected / exposed
    1 / 717 (0.14%)
    3 / 742 (0.40%)
         occurrences all number
    1
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 717 (0.42%)
    2 / 742 (0.27%)
         occurrences all number
    3
    2
    Acute tonsillitis
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Bronchopneumonia
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    8 / 717 (1.12%)
    7 / 742 (0.94%)
         occurrences all number
    8
    7
    Enterobiasis
         subjects affected / exposed
    2 / 717 (0.28%)
    0 / 742 (0.00%)
         occurrences all number
    2
    0
    Gastroenteritis
         subjects affected / exposed
    7 / 717 (0.98%)
    13 / 742 (1.75%)
         occurrences all number
    7
    13
    Fungal infection
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Herpes virus infection
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Impetigo
         subjects affected / exposed
    1 / 717 (0.14%)
    1 / 742 (0.13%)
         occurrences all number
    1
    1
    Infection parasitic
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    3 / 717 (0.42%)
    1 / 742 (0.13%)
         occurrences all number
    3
    1
    Influenza
         subjects affected / exposed
    1 / 717 (0.14%)
    6 / 742 (0.81%)
         occurrences all number
    1
    6
    Nasopharyngitis
         subjects affected / exposed
    27 / 717 (3.77%)
    32 / 742 (4.31%)
         occurrences all number
    27
    32
    Otitis media
         subjects affected / exposed
    3 / 717 (0.42%)
    1 / 742 (0.13%)
         occurrences all number
    3
    1
    Otitis media acute
         subjects affected / exposed
    2 / 717 (0.28%)
    5 / 742 (0.67%)
         occurrences all number
    2
    5
    Pharyngitis
         subjects affected / exposed
    9 / 717 (1.26%)
    17 / 742 (2.29%)
         occurrences all number
    9
    17
    Pharyngotonsillitis
         subjects affected / exposed
    3 / 717 (0.42%)
    2 / 742 (0.27%)
         occurrences all number
    3
    2
    Respiratory tract infection
         subjects affected / exposed
    2 / 717 (0.28%)
    0 / 742 (0.00%)
         occurrences all number
    2
    0
    Pneumonia
         subjects affected / exposed
    1 / 717 (0.14%)
    1 / 742 (0.13%)
         occurrences all number
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Scarlet fever
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 717 (0.00%)
    1 / 742 (0.13%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 717 (0.14%)
    2 / 742 (0.27%)
         occurrences all number
    1
    2
    Tonsillitis
         subjects affected / exposed
    20 / 717 (2.79%)
    11 / 742 (1.48%)
         occurrences all number
    20
    11
    Tooth infection
         subjects affected / exposed
    1 / 717 (0.14%)
    0 / 742 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis streptococcal
         subjects affected / exposed
    2 / 717 (0.28%)
    1 / 742 (0.13%)
         occurrences all number
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 717 (1.53%)
    11 / 742 (1.48%)
         occurrences all number
    11
    11
    Varicella
         subjects affected / exposed
    2 / 717 (0.28%)
    2 / 742 (0.27%)
         occurrences all number
    2
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 717 (0.28%)
    3 / 742 (0.40%)
         occurrences all number
    2
    3
    Viral infection
         subjects affected / exposed
    1 / 717 (0.14%)
    2 / 742 (0.27%)
         occurrences all number
    1
    2
    Vulvovaginitis
         subjects affected / exposed
    1 / 717 (0.14%)
    1 / 742 (0.13%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 717 (0.00%)
    3 / 742 (0.40%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Sep 2006
    AM1 - The protocol was amended to include only participants who received the primary series of hepatitis B vaccine through the birth, 1, and 6 months of age and birth, 2, and 6 months of age schedules for Cohorts A and B. Additionally, this amendment clarified that participants in Cohort C were to be enrolled in Canada or other countries, as needed, and that the study design was changed from single-blind to open-label for Cohorts A and B.
    25 Jul 2007
    AM2 - The protocol was amended to include healthy male and female children 4 to 7 years of age and born between 2000 and 2002.
    01 Nov 2007
    AM3 - The protocol was amended to include healthy male and female children 4 to 8 years of age and born between 2000 and 2003.

    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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