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    Clinical Trial Results:
    Long-Term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 To 5 Year-Old Children Previously Vaccinated With a 2-Dose Or 3-Dose Infants Series and Toddler Dose With Vaxelis® or INFANRIX® hexa

    Summary
    EudraCT number
    2016-000274-37
    Trial protocol
    FI  
    Global end of trial date
    01 Aug 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jun 2019
    First version publication date
    09 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V419-012
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02759354
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Merck Protocol Number: V419-012
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, 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
    01 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study was to assess the long-term persistence of hepatitis B surface antigen (HBsAg) and pertussis antibodies after vaccination with Vaxelis®. The present study was therefore an extended follow-up of the 4 to 5 year-old participants who participated in two previous clinical studies (V419-007 and V419-008), without any vaccine administration, and a blood sample as the main procedure. Its design was driven by both initial studies design and timing.
    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
    26 Apr 2016
    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: 754
    Worldwide total number of subjects
    754
    EEA total number of subjects
    754
    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)
    754
    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 multicenter extension study was conducted in Finland at approximately 10 sites from studies V419-007 and V419-008, which had eligible participants (i.e. participants who completed the full 3+1 or 2+1 vaccination schedule in the original studies).

    Pre-assignment
    Screening details
    Of the 760 screened participants, 754 were enrolled and completed the study. A total of 752 participants were included in the Persistence Analysis Set, 752 with blood samples available for hepatitis B surface antigen (HBsAg) analyses, and 751 for pertussis analyses.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group Vaxelis (3+1)
    Arm description
    Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (approximately [~] 4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
    Arm type
    Experimental

    Investigational medicinal product name
    Blood Sample
    Investigational medicinal product code
    Other name
    Vaxelis®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Blood sample at ~4 years of age

    Arm title
    Group Infanrix hexa (3+1)
    Arm description
    Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
    Arm type
    Active comparator

    Investigational medicinal product name
    Blood sample
    Investigational medicinal product code
    Other name
    INFANRIX® hexa
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Blood sample at ~4 years of age

    Arm title
    Group Vaxelis (2+1)
    Arm description
    Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
    Arm type
    Experimental

    Investigational medicinal product name
    Blood sample
    Investigational medicinal product code
    Other name
    Vaxelis®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Blood sample at ~4 years of age

    Arm title
    Group Infanrix hexa (2+1)
    Arm description
    Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
    Arm type
    Active comparator

    Investigational medicinal product name
    Blood sample
    Investigational medicinal product code
    Other name
    INFANRIX® hexa
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Blood sample at ~4 years of age

    Number of subjects in period 1
    Group Vaxelis (3+1) Group Infanrix hexa (3+1) Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Started
    192
    190
    181
    191
    Completed
    192
    190
    181
    191

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group Vaxelis (3+1)
    Reporting group description
    Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (approximately [~] 4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Reporting group title
    Group Infanrix hexa (3+1)
    Reporting group description
    Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Reporting group title
    Group Vaxelis (2+1)
    Reporting group description
    Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Reporting group title
    Group Infanrix hexa (2+1)
    Reporting group description
    Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Reporting group values
    Group Vaxelis (3+1) Group Infanrix hexa (3+1) Group Vaxelis (2+1) Group Infanrix hexa (2+1) Total
    Number of subjects
    192 190 181 191 754
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    192 190 181 191 754
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    0 0 0 0 0
        From 65-84 years
    0 0 0 0 0
        85 years and over
    0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    4.8 ± 0.2 4.8 ± 0.2 3.9 ± 0.1 3.9 ± 0.1 -
    Sex: Female, Male
    Units: Subjects
        Female
    99 86 84 94 363
        Male
    93 104 97 97 391

    End points

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    End points reporting groups
    Reporting group title
    Group Vaxelis (3+1)
    Reporting group description
    Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (approximately [~] 4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Reporting group title
    Group Infanrix hexa (3+1)
    Reporting group description
    Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Reporting group title
    Group Vaxelis (2+1)
    Reporting group description
    Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Reporting group title
    Group Infanrix hexa (2+1)
    Reporting group description
    Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Primary: Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)

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    End point title
    Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg) [1]
    End point description
    Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. Response was defined as a titer >=10 milli International units (mIU)/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 3+1 or 2+1 schedule, as part of studies V419 007 or V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Primary
    End point timeframe
    Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)
    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 analyses were reported for this end point.
    End point values
    Group Vaxelis (3+1) Group Infanrix hexa (3+1) Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    191
    189
    181
    190
    Units: Percentage of Participants
        number (confidence interval 95%)
    70.16 (63.13 to 76.55)
    82.01 (75.78 to 87.21)
    65.75 (58.34 to 72.63)
    83.68 (77.65 to 88.64)
    No statistical analyses for this end point

    Primary: Percentage of Participants Responding to Pertussis Toxin

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    End point title
    Percentage of Participants Responding to Pertussis Toxin [2] [3]
    End point description
    Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. The unit of measure is ELISA units/mL. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Primary
    End point timeframe
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Notes
    [2] - 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: This endpoint does not exist for the two groups in V419-007 and accordingly there are no statistics to report.
    [3] - 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: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule).
    End point values
    Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    178
    188
    Units: Percentage of participants
    number (confidence interval 95%)
        Concentration ≥LLOQ
    58.43 (50.82 to 65.75)
    41.49 (34.37 to 48.89)
        Concentration ≥2×LLOQ
    40.45 (33.17 to 48.05)
    21.81 (16.13 to 28.40)
        Concentration ≥4×LLOQ
    14.61 (9.77 to 20.67)
    3.72 (1.51 to 7.52)
    No statistical analyses for this end point

    Primary: Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin

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    End point title
    Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin [4] [5]
    End point description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. LLOQ=3 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Primary
    End point timeframe
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Notes
    [4] - 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: This endpoint does not exist for the two groups in V419-007 and accordingly there are no statistics to report.
    [5] - 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: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule).
    End point values
    Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    173
    188
    Units: Percentage of participants
    number (confidence interval 95%)
        Concentration ≥LLOQ
    80.92 (74.27 to 86.49)
    88.30 (82.82 to 92.52)
        Concentration ≥2×LLOQ
    46.82 (39.21 to 54.54)
    70.74 (63.68 to 77.14)
        Concentration ≥4×LLOQ
    26.01 (19.65 to 33.22)
    45.21 (37.96 to 52.62)
    No statistical analyses for this end point

    Primary: Percentage of Participants Responding to Pertussis Pertactin

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    End point title
    Percentage of Participants Responding to Pertussis Pertactin [6] [7]
    End point description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Primary
    End point timeframe
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    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: This endpoint does not exist for the two groups in V419-007 and accordingly there are no statistics to report.
    [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: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule).
    End point values
    Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    180
    190
    Units: Percentage of participants
    number (confidence interval 95%)
        Concentration ≥LLOQ
    66.11 (58.70 to 72.99)
    72.63 (65.71 to 78.84)
        Concentration ≥2×LLOQ
    43.89 (36.52 to 51.47)
    51.05 (43.71 to 58.36)
        Concentration ≥4×LLOQ
    15.56 (10.59 to 21.69)
    18.42 (13.18 to 24.68)
    No statistical analyses for this end point

    Primary: Percentage of Participants Responding to Pertussis Fimbriae

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    End point title
    Percentage of Participants Responding to Pertussis Fimbriae [8] [9]
    End point description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Primary
    End point timeframe
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Notes
    [8] - 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: This endpoint does not exist for the two groups in V419-007 and accordingly there are no statistics to report.
    [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: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule).
    End point values
    Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    177
    183
    Units: Percentage of participants
    number (confidence interval 95%)
        Concentration ≥LLOQ
    94.35 (89.86 to 97.26)
    3.28 (1.21 to 7.00)
        Concentration ≥2×LLOQ
    88.14 (82.44 to 92.50)
    2.19 (0.60 to 5.50)
        Concentration ≥4×LLOQ
    69.49 (62.14 to 76.18)
    1.09 (0.13 to 3.89)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of Antibodies to HBsAg

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    End point title
    Geometric Mean Concentration of Antibodies to HBsAg
    End point description
    Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. The unit of measure is milli International Units/mL (mIU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 3+1 or 2+1 schedule, as part of studies V419 007 or V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Secondary
    End point timeframe
    Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)
    End point values
    Group Vaxelis (3+1) Group Infanrix hexa (3+1) Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    191
    189
    181
    190
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    24.43 (19.52 to 30.59)
    51.30 (40.19 to 65.46)
    19.44 (15.48 to 24.40)
    71.00 (54.94 to 91.77)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of Antibodies to Pertussis Toxin

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    End point title
    Geometric Mean Concentration of Antibodies to Pertussis Toxin [10]
    End point description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Secondary
    End point timeframe
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    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: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule).
    End point values
    Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    178
    188
    Units: EU/mL
        geometric mean (confidence interval 95%)
    5.31 (4.61 to 6.12)
    3.64 (3.24 to 4.09)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin

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    End point title
    Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin [11]
    End point description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Secondary
    End point timeframe
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Notes
    [11] - 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: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule).
    End point values
    Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    173
    188
    Units: EU/mL
        geometric mean (confidence interval 95%)
    6.62 (5.54 to 7.91)
    11.05 (9.13 to 13.37)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of Antibodies to Pertussis Pertactin

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    End point title
    Geometric Mean Concentration of Antibodies to Pertussis Pertactin [12]
    End point description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Secondary
    End point timeframe
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Notes
    [12] - 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: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule).
    End point values
    Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    180
    190
    Units: EU/mL
        geometric mean (confidence interval 95%)
    5.94 (5.14 to 6.86)
    7.19 (6.20 to 8.33)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of Antibodies to Pertussis Fimbriae

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    End point title
    Geometric Mean Concentration of Antibodies to Pertussis Fimbriae [13]
    End point description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Secondary
    End point timeframe
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Notes
    [13] - 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: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule).
    End point values
    Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    177
    183
    Units: EU/mL
        geometric mean (confidence interval 95%)
    25.99 (21.90 to 30.85)
    2.13 (2.01 to 2.25)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants with One or More Serious Adverse Events Related to Study Procedure

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    End point title
    Percentage of Participants with One or More Serious Adverse Events Related to Study Procedure
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death or is life-threatening. Life-threatening in this context refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 3+1 or 2+1 schedule, as part of studies V419 007 or V419-008 respectively, for whom immunogenicity results were available.
    End point type
    Other pre-specified
    End point timeframe
    Up to 4 days following blood sample on Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)
    End point values
    Group Vaxelis (3+1) Group Infanrix hexa (3+1) Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Number of subjects analysed
    191
    189
    181
    191
    Units: Percentage of Participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 4 days after Day 1
    Adverse event reporting additional description
    Adverse Events (AEs) are reported for the Persistence Analysis Set which included all participants previously vaccinated in studies V419-007 or V419-008 with immunogenicity results available. Vaccine safety was not assessed in this study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Group Vaxelis (3+1)
    Reporting group description
    Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (approximately [~] 4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Reporting group title
    Group Infanrix hexa (3+1)
    Reporting group description
    Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Reporting group title
    Group Vaxelis (2+1)
    Reporting group description
    Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Reporting group title
    Group Infanrix hexa (2+1)
    Reporting group description
    Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.

    Serious adverse events
    Group Vaxelis (3+1) Group Infanrix hexa (3+1) Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 189 (0.00%)
    0 / 181 (0.00%)
    0 / 191 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Group Vaxelis (3+1) Group Infanrix hexa (3+1) Group Vaxelis (2+1) Group Infanrix hexa (2+1)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 189 (0.00%)
    0 / 181 (0.00%)
    0 / 191 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No vaccine was administered in this study; therefore, vaccine safety was not assessed in this study.

    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.
    Vaccine safety was not assessed in the present study.
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