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    Clinical Trial Results:
    Immunogenicity and Safety of Sanofi Pasteur’s DTaP-IPV-HB-PRP~T Combined Vaccine Given as a Three-Dose Primary Series at 2, 3, 4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or within 1 Week after Birth

    Summary
    EudraCT number
    2017-004181-10
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 Jan 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    13 May 2018
    First version publication date
    13 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3L35
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02428491
    WHO universal trial number (UTN)
    U1111-1143-8177
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    14 Espace Henry Vallée, Lyon, France, 69007
    Public contact
    Director, Clinical Development, Sanofi Pasteur, +33 (0)4 37 37 74 64, Olga.Lyabis@Sanofi.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur, +33 (0)4 37 37 74 64, Olga.Lyabis@Sanofi.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
    31 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety profile after each and all doses of Sanofi Pasteur's DTaP-IPV-HB-PRP~T in Vietnamese infants and toddlers.
    Protection of trial subjects
    All subjects that met all the study inclusion and none of the exclusion criteria, including one subject who did not meet an inclusion criterion, were randomized and vaccinated. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Apr 2015
    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
    Vietnam: 354
    Worldwide total number of subjects
    354
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    354
    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
    Study subjects were enrolled in 1 centre in Vietnam from 20 April 2015 to 23 October 2015.

    Pre-assignment
    Screening details
    A total of 354 subjects who met all of the inclusion criteria and none of the exclusion criteria, including one subject who did not meet an inclusion criterion were randomized and vaccinated in this study.

    Period 1
    Period 1 title
    DTaP-IPV-HB-PRP~T Vaccine (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    DTaP-IPV-HB-PRP~T Vaccine
    Arm description
    Subjects received 3 doses of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age (Infant Series), followed by a booster dose approximately 12 months after the completion of the Infant Series (at 16 to 17 months of age).
    Arm type
    Experimental

    Investigational medicinal product name
    DTaP-IPV-HB-PRP~T Combined Vaccine
    Investigational medicinal product code
    Other name
    Hexaxim
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the right thigh.

    Number of subjects in period 1
    DTaP-IPV-HB-PRP~T Vaccine
    Started
    354
    Subjects completed the Infant Series
    352
    Subjects completed Booster vaccination
    349
    Completed
    346
    Not completed
    8
         Protocol deviation
             4
         Consent withdrawn by subject
             4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTaP-IPV-HB-PRP~T Vaccine
    Reporting group description
    Subjects received 3 doses of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age (Infant Series), followed by a booster dose approximately 12 months after the completion of the Infant Series (at 16 to 17 months of age).

    Reporting group values
    DTaP-IPV-HB-PRP~T Vaccine Total
    Number of subjects
    354 354
    Age categorical
    Units: Subjects
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    75.4 ± 8.6 -
    Gender categorical
    Units: Subjects
        Female
    175 175
        Male
    179 179
    Recruitment by cohort
    Subjects in this trial were randomized in a 1:1 ratio in 2 cohorts. All subjects in both cohorts received Sanofi Pasteur’s DTaP-IPV-HB-PRP~T combined vaccine in a 3-dose Infant Series. Subjects from Cohort 1 provided blood samples for immunogenicity assessment and were evaluated for safety and immunogenicity. Subjects in Cohort 2 did not provide any blood samples for immunogenicity analysis and were evaluated for safety only.
    Units: Subjects
        Cohort 1
    178 178
        Cohort 2
    176 176

    End points

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    End points reporting groups
    Reporting group title
    DTaP-IPV-HB-PRP~T Vaccine
    Reporting group description
    Subjects received 3 doses of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age (Infant Series), followed by a booster dose approximately 12 months after the completion of the Infant Series (at 16 to 17 months of age).

    Subject analysis set title
    Group 3 A3L15
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects from Study A3L15 (NCT01105559 and 2011-004450-26), who had been given DTaP-IPV-HB-PRP~T vaccine at 6, 10, and 14 weeks of age following Hep B vaccination at birth, were included in this group for the non-inferiority analysis.

    Primary: Number of Subjects Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) After Infant Series

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    End point title
    Number of Subjects Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) After Infant Series [1]
    End point description
    A solicited reaction was an AE prelisted in the electronic case report from (eCRF) and considered to be related to vaccination. Injection site reactions: pain (Grade 3: Cried when injected limb was moved, or the movement of the injected limb was reduced), erythema and swelling (Grade 3: >= 50 mm). Number of subjects with any solicited injection-site reaction and Grade 3 solicited injection-site reactions were reported. Analysis was performed on safety analysis set after infant series, which included all subjects who received at least 1 dose of infant series vaccine.
    End point type
    Primary
    End point timeframe
    Within 7 days after any vaccination
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    DTaP-IPV-HB-PRP~T Vaccine
    Number of subjects analysed
    354
    Units: subjects
        Any Injection site pain
    205
        Grade 3 Injection site pain
    2
        Any Injection site erythema
    113
        Grade 3 Injection site erythema
    6
        Any Injection site swelling
    47
        Grade 3 Injection site swelling
    5
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Solicited Systemic Reactions (Pyrexia, Vomiting, Crying, Somnolence, Decreased Appetite, Irritability) After Infant Series

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    End point title
    Number of Subjects Reporting Solicited Systemic Reactions (Pyrexia, Vomiting, Crying, Somnolence, Decreased Appetite, Irritability) After Infant Series [2]
    End point description
    A solicited reaction was an AE prelisted in eCRF and considered to be related to vaccination. Systemic reactions: pyrexia (Grade 3: >39.5 degree Celsius), vomiting (Grade 3: >= 6 episodes per 24 hours), crying (Grade 3: >3 hours), somnolence (Grade 3: Sleeping most of the time/difficult to wake up), decreased appetite (Grade 3: Refuses >=3 feeds/meals or most feeds/meals) & irritability (Grade 3: Inconsolable). Number of subjects with any systemic reaction and Grade 3 systemic reactions were reported. Analysis was performed on safety analysis set after infant series. Here, "n" signifies number of subjects with available data for each category.
    End point type
    Primary
    End point timeframe
    Within 7 days after any vaccination
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    DTaP-IPV-HB-PRP~T Vaccine
    Number of subjects analysed
    354
    Units: subjects
        Any Pyrexia (n=353)
    71
        Grade 3 Pyrexia (n=353)
    0
        Any Vomiting (n=354)
    82
        Grade 3 Vomiting (n=354)
    0
        Any Crying (n=354)
    158
        Grade 3 Crying (n=354)
    3
        Any Somnolence (n=354)
    141
        Grade 3 Somnolence (n=354)
    0
        Any Decreased appetite (n=354)
    108
        Grade 3 Decreased appetite (n=354)
    2
        Any Irritability (n=354)
    119
        Grade 3 Irritability (n=354)
    3
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb) After Booster Vaccination

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    End point title
    Number of Subjects Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb) After Booster Vaccination [3]
    End point description
    A solicited reaction was an AE prelisted in the eCRF and considered to be related to vaccination. Injection site reactions: pain (Grade 3: Cried when injected limb was moved, or the movement of the injected limb was reduced), erythema and swelling (Grade 3: >= 50 mm). Number of subjects with any solicited injection-site systemic reaction and Grade 3 solicited injection-site reactions were reported. Analysis was performed on safety analysis set after booster dose, which included all subjects who received booster vaccine.
    End point type
    Primary
    End point timeframe
    Within 7 days after vaccination
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    DTaP-IPV-HB-PRP~T Vaccine
    Number of subjects analysed
    349
    Units: subjects
        Any Injection site pain
    83
        Grade 3 Injection site pain
    0
        Any Injection site erythema
    37
        Grade 3 Injection site erythema
    2
        Any Injection site swelling
    29
        Grade 3 Injection site swelling
    1
        Any Extensive swelling of vaccinated limb
    0
        Grade 3 Extensive swelling of vaccinated limb
    0
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Solicited Systemic Reactions (Pyrexia, Vomiting, Crying, Somnolence, Decreased Appetite, Irritability) After Booster Vaccination

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    End point title
    Number of Subjects Reporting Solicited Systemic Reactions (Pyrexia, Vomiting, Crying, Somnolence, Decreased Appetite, Irritability) After Booster Vaccination [4]
    End point description
    A solicited reaction is an AE prelisted in the eCRF and considered to be related to vaccination. Systemic reactions: pyrexia (Grade 3: >39.5 degree Celsius), vomiting (Grade 3: >=6 episodes per 24 hours), crying (Grade 3: >3 hours), somnolence (Grade 3: Sleeping most of the time or difficult to wake up), decreased appetite (Grade 3: Refuses>=3 feeds/meals or most feeds/meals) & irritability (Grade 3: Inconsolable). Number of subjects with any systemic reaction and Grade 3 systemic reactions were reported. Analysis was performed on safety analysis set after booster dose. Here, "n" signifies number of subjects with available data for each category.
    End point type
    Primary
    End point timeframe
    Within 7 days after vaccination
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    DTaP-IPV-HB-PRP~T Vaccine
    Number of subjects analysed
    349
    Units: subjects
        Any Pyrexia (n=348)
    36
        Grade 3 Pyrexia (n=348)
    0
        Any Vomiting (n=349)
    11
        Grade 3 Vomiting (n=349)
    1
        Any Crying (n=349)
    32
        Grade 3 Crying (n=349)
    0
        Any Somnolence (n=349)
    25
        Grade 3 Somnolence (n=349)
    0
        Any Decreased appetite (n=349)
    53
        Grade 3 Decreased appetite (n=349)
    1
        Any Irritability (n=349)
    45
        Grade 3 Irritability (n=349)
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Seroprotection/Seroconversion/Vaccine Response After Infant Series in Cohort 1

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    End point title
    Number of Subjects With Seroprotection/Seroconversion/Vaccine Response After Infant Series in Cohort 1
    End point description
    Seroconversion:4fold increase in anti-Pertussis(PT)& anti-Filamentous hemagglutinin(FHA) antibody(Ab) concentrations from pre-vaccination to one month after first dose.Vaccine response:anti-PT/anti-FHA Ab concentrations in Enzyme Linked Immunosorbent Assay(ELISA) units(EU)/mL>=4*Lower Limit of Quantitation(LLOQ) if pre-vaccination concentration <4*LLOQ/>=pre-vaccination concentration if pre-vaccination concentrations>=4*LLOQ. Seroprotection:anti-Diphtheria &anti-Tetanus>=0.01 International Units(IU)/mL&>=0.1 IU/mL;anti-PT &anti-FHA>=2 EU/mL &>=8 EU/mL;anti-Polyribosyl Ribitol Phosphate(PRP)>=0.15 microgram per milliliter(mcg/mL) &>=1.0mcg/mL;anti-Polio types 1,2,&3>=8(1/dilution),anti-Hepatitis B>=10 mili-international units per mililiter(mIU/mL)&>=100 mIU/mL.Analysis performed on per protocol analysis set which included subjects from Cohort 1 who received at least one dose of study vaccine & excluding those who had protocol deviations.n=subjects with available data for each category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination, only for anti-PT and anti-FHA) and Day 90 (1 month after third dose)
    End point values
    DTaP-IPV-HB-PRP~T Vaccine
    Number of subjects analysed
    167
    Units: subjects
        Anti-Diphtheria; Day 90(>= 0.01 IU/mL) (n= 163)
    162
        Anti-Diphtheria; Day 90 (>= 0.1 IU/mL) (n= 163)
    59
        Anti-Tetanus; Day 90 (>= 0.01 IU/mL) (n= 166)
    166
        Anti-Tetanus; Day 90 (>= 0.1 IU/mL) (n= 166)
    166
        Anti-PT; Day 0 (>=2 EU/mL) (n= 167)
    84
        Anti-PT; Day 0 (>=8 EU/mL) (n= 167)
    24
        Anti-PT; Day 0/Day 90 (Vaccine Response) (n= 167)
    166
        Anti-PT; Day 0/Day 90(Seroconversion) (n= 167)
    160
        Anti-FHA; Day 0 (>=2 EU/mL) (n= 167)
    149
        Anti-FHA; Day 0 (>=8 EU/mL) (n= 167)
    64
        Anti-FHA; Day 0/Day 90 (Vaccine Response) (n= 167)
    167
        Anti-FHA; Day 0/Day 90 (Seroconversion) (n= 167)
    161
        Anti-Polio 1; Day 90 (>=8 [1/dil]) (n= 163)
    163
        Anti-Polio 2; Day 90 (>=8 [1/dil]) (n= 164)
    164
        Anti-Polio 3; Day 90 (>=8 [1/dil]) (n= 166)
    166
        Anti- Hep B; Day 90 (>=10 mIU/mL) (n= 167)
    164
        Anti- Hep B; Day 90 (>=100 mIU/mL) (n= 167)
    159
        Anti-PRP; Day 90 (>=0.15 mcg/mL) (n= 166)
    157
        Anti-PRP; Day 90 (>=1.0 mcg/mL) (n= 166)
    122
    No statistical analyses for this end point

    Secondary: Number of Subjects With Seroprotection/Seroconversion/Vaccine and Booster Response Before and After Booster Vaccination in Cohort 1

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    End point title
    Number of Subjects With Seroprotection/Seroconversion/Vaccine and Booster Response Before and After Booster Vaccination in Cohort 1
    End point description
    Seroconversion:4fold increase in anti-PT & anti-FHA Ab concentrations from pre-booster vaccination to 1 month after booster dose.Vaccine response post-booster vaccination:post-booster Ab concentrations>=4*LLOQ if pre-dose 1 Ab concentrations<4*LLOQ/post-booster Ab concentrations>=pre-dose 1 Ab concentrations if pre-dose 1>=4*LLOQ. Booster response:>=4 fold Ab concentrations increase from pre-dose 4 to one-month post-dose 4 if one-month post-dose 3<4*LLOQ/>=2 fold Ab concentrations increase from pre-dose 4 to one-month post-dose 4 if pre-dose 4>=4*LLOQ.Seroprotection:anti-Diphtheria & anti-Tetanus>=0.01 IU/mL &>=0.1 IU/mL &>=1.0 IU/mL;anti-PRP >=0.15 mcg/mL &>=1.0 mcg/mL;anti-Polio types 1, 2, & 3>=8 (1/dilution),anti-Hepatitis B>=10 mIU/mL &>=100 mIU/mL. Analysis performed on booster per-protocol analysis set which included subjects from Cohort 1 who received booster dose of study vaccine & excluding those who had protocol deviations.n=subjects with available data for each category.
    End point type
    Secondary
    End point timeframe
    Day 425 (pre-booster) and Day 455 (1 month after booster dose)
    End point values
    DTaP-IPV-HB-PRP~T Vaccine
    Number of subjects analysed
    167
    Units: subjects
        Anti-Diphtheria; Day 425 (> =0.01 IU/mL) (n=167)
    163
        Anti-Diphtheria; Day 425 (>=0.1 IU/mL) (n=167)
    57
        Anti-Diphtheria; Day 455 (> =0.01 IU/mL) (n=166)
    166
        Anti-Diphtheria; Day 455 (> =0.1 IU/mL) (n=166)
    166
        Anti-Diphtheria; Day 455 (> =1.0 IU/mL) (n=166)
    158
        Anti-Tetanus; Day 425 (> =0.01 IU/mL) (n=167)
    167
        Anti-Tetanus; Day 425 (> =0.1 IU/mL) (n=167)
    142
        Anti-Tetanus; Day 455 (> = 0.01 IU/mL) (n=165)
    165
        Anti-Tetanus; Day 455 (> =0.1 IU/mL) (n=165)
    165
        Anti-Tetanus; Day 455 (> =1.0 IU/mL) (n=165)
    164
        Anti-PT; Day 425 (> =2 EU/mL) (n=160)
    130
        Anti-PT; Day 425 (> =8 EU/mL) (n=160)
    44
        Anti-PT; Day 455/ Day 0 (Vaccine Response) (n=166)
    166
        Anti-PT;Day 455/Day 425(Booster Response)(n=160)
    157
        Anti-PT; Day 455/Day 425 (Seroconversion) (n=160)
    155
        Anti-FHA; Day 425 (> =2 EU/mL) (n=164)
    164
        Anti-FHA; Day 425 (> =8 EU/mL) (n=164)
    141
        Anti-FHA; Day 455/Day 0 (Vaccine Response) (n=166)
    166
        Anti-FHA; Day 455/Day 425(Booster Response)(n=163)
    158
        Anti-FHA; Day 455/Day 425 (Seroconversion) (n=163)
    147
        Anti-Polio 1; Day 425 (> =8 [1/dil]) (n=167)
    161
        Anti-Polio 1; Day 455 (> =8 [1/dil]) (n=164)
    164
        Anti-Polio 2; Day 425 (> =8 [1/dil]) (n=167)
    165
        Anti-Polio 2; Day 455 (> =8 [1/dil]) (n=163)
    163
        Anti-Polio 3; Day 425 (> =8 [1/dil]) (n=167)
    159
        Anti-Polio 3; Day 455 (> =8 [1/dil]) (n=164)
    164
        Anti-Hep B; Day 425 (> =10 mIU/mL) (n=167)
    153
        Anti-Hep B; Day 425 (> =100 mIU/mL) (n=167)
    94
        Anti- Hep B; Day 455 (> =10 mIU/mL) (n=167)
    164
        Anti- Hep B; Day 455 (> =100 mIU/mL) (n=167)
    161
        Anti-PRP; Day 425 (> =0.15 mcg/mL) (n=167)
    135
        Anti-PRP; Day 425 (> =1.0 mcg/mL) (n=167)
    77
        Anti-PRP; Day 455 (> =0.15 mcg/mL) (n=167)
    167
        Anti-PRP; Day 455 (> =1.0 mcg/mL) (n=167)
    167
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Infant Series in Cohort 1

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    End point title
    Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Infant Series in Cohort 1
    End point description
    Anti-diphtheria Ab levels were measured by a toxin neutralization test. Anti-tetanus, anti- pertussis toxin (anti-PT) and anti- filamentous hemagglutinin (anti-FHA) Ab levels were measured by ELISA. Anti-poliovirus types 1, 2, and 3 Ab levels were measured by neutralization assay. Anti-Hep B Ab levels were measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels were measured using a Farr-type radioimmunoassay (RIA). Analysis was performed on per-protocol analysis set which included subjects from Cohort 1 who received at least one dose of study vaccine and excluding those who had protocol deviations. Here, "n" signifies number of subjects with available data for each category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination, only for anti-PT and anti-FHA) and Day 90 (1 month after third dose)
    End point values
    DTaP-IPV-HB-PRP~T Vaccine
    Number of subjects analysed
    167
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Day 90 (n= 163)
    0.080 (0.069 to 0.092)
        Anti-Tetanus; Day 90 (n= 166)
    1.16 (1.02 to 1.31)
        Anti-PT; Day 0 (n= 167)
    2.35 (2.01 to 2.75)
        Anti-PT; Day 90 (n= 167)
    111 (99 to 125)
        Anti-FHA; Day 0 (n= 167)
    5.44 (4.69 to 6.31)
        Anti-FHA; Day 90 (n= 167)
    208 (190 to 228)
        Anti-Polio 1; Day 90 (n= 163)
    283 (237 to 337)
        Anti-Polio 2; Day 90 (n= 164)
    582 (476 to 712)
        Anti-Polio 3; Day 90 (n= 166)
    735 (582 to 927)
        Anti- Hep B; Day 90 (n= 167)
    1383 (1092 to 1752)
        Anti-PRP; Day 90 (n= 163)
    2.48 (1.95 to 3.14)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Booster Vaccination in Cohort 1

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    End point title
    Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Booster Vaccination in Cohort 1
    End point description
    Anti-diphtheria Ab were measured by a toxin neutralization test. Anti-tetanus, anti-PT and anti-FHA Ab levels were measured by ELISA. Anti-poliovirus types 1, 2, and 3 Ab levels were measured by neutralization assay. Anti-Hep B Ab levels were measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels were measured using a Farr-type RIA. Analysis was performed on booster per-protocol analysis set which included subjects from Cohort 1 who received the booster dose of study vaccine and excluding those who had protocol deviations. Here, "n" signifies number of subjects with available data for each category.
    End point type
    Secondary
    End point timeframe
    Day 425 (pre-booster) and Day 455 (1 month after booster dose)
    End point values
    DTaP-IPV-HB-PRP~T Vaccine
    Number of subjects analysed
    176
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Day 425 (n=167)
    0.065 (0.054 to 0.078)
        Anti-Diphtheria; Day 455 (n=166)
    5.36 (4.56 to 6.30)
        Anti-Tetanus; Day 425 (n=167)
    0.242 (0.211 to 0.277)
        Anti-Tetanus; Day 455 (n=165)
    10.0 (8.85 to 11.4)
        Anti-PT; Day 425 (n=160)
    4.80 (4.00 to 5.75)
        Anti-PT; Day 455 (n=167)
    94.9 (84.7 to 106)
        Anti-FHA; Day 425 (n=164)
    18.3 (15.7 to 21.4)
        Anti-FHA; Day 455 (n=166)
    216 (192 to 242)
        Anti-Polio 1; Day 425 (n=167)
    68.1 (55.7 to 83.2)
        Anti-Polio 1; Day 455 (n=164)
    2173 (1888 to 2501)
        Anti-Polio 2; Day 425 (n=167)
    113 (92.6 to 137)
        Anti-Polio 2; Day 455 (n=163)
    3867 (3330 to 4492)
        Anti-Polio 3; Day 425 (n=167)
    61.7 (48.7 to 78.1)
        Anti-Polio 3; Day 455 (n=164)
    2812 (2411 to 3280)
        Anti-Hep B; Day 425 (n=167)
    101 (80.6 to 126)
        Anti-Hep B; Day 455 (n=167)
    5554 (4256 to 7247)
        Anti-PRP; Day 425 (n=167)
    0.806 (0.619 to 1.05)
        Anti-PRP; Day 455 (n=167)
    79.2 (64.9 to 96.6)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratio of DTaP-IPV-HB-PRP~T Antibodies After Infant Series in Cohort 1 for PT and FHA Antigens

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    End point title
    Geometric Mean Titer Ratio of DTaP-IPV-HB-PRP~T Antibodies After Infant Series in Cohort 1 for PT and FHA Antigens
    End point description
    Anti-PT and anti-FHA Ab levels were measured by ELISA. Analysis was performed on per-protocol analysis set which included subjects from Cohort 1 who received at least one dose of study vaccine and excluding those who had protocol deviations.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 90 (1 month after third dose)
    End point values
    DTaP-IPV-HB-PRP~T Vaccine
    Number of subjects analysed
    167
    Units: Ratio
    number (confidence interval 95%)
        Anti-PT; Day 90/Day 0
    47.2 (38.4 to 58.1)
        Anti-FHA; Day 90/Day 0
    38.2 (32.0 to 45.7)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration/Titer Ratio of DTaP-IPV-HB-PRP~T Antibodies After Booster Vaccination in Cohort 1

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    End point title
    Geometric Mean Concentration/Titer Ratio of DTaP-IPV-HB-PRP~T Antibodies After Booster Vaccination in Cohort 1
    End point description
    Anti-diphtheria Ab were measured by a toxin neutralization test. Anti-tetanus, anti-PT and anti-FHA Ab levels were measured by ELISA. Anti-poliovirus types 1, 2, and 3 Ab levels were measured by neutralization assay. Anti-Hep B Ab levels were measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels were measured using a Farr-type RIA. Analysis was performed on booster per-protocol analysis set which included subjects from Cohort 1 who received the booster dose of study vaccine and excluding those who had protocol deviations. Here, "n" signifies number of subjects with available data for each category.
    End point type
    Secondary
    End point timeframe
    Day 425 (pre-booster) and Day 455 (1 month after booster dose)
    End point values
    DTaP-IPV-HB-PRP~T Vaccine
    Number of subjects analysed
    176
    Units: Ratio
    number (confidence interval 95%)
        Anti-Diphtheria; Day 455/Day 425 (n=166)
    82.6 (71.1 to 95.8)
        Anti-Tetanus; Day 455 /Day 425 (n=165)
    41.3 (36.9 to 46.2)
        Anti-PT; Day 455 /Day 425 (n=160)
    19.9 (17.2 to 23.0)
        Anti-FHA; Day 455 /Day 425 (n=163)
    11.9 (10.4 to 13.5)
        Anti-Polio 1; Day 455 /Day 425 (n=164)
    32.8 (26.4 to 40.6)
        Anti-Polio 2; Day 455 /Day 425 (n=163)
    34.5 (27.6 to 43.0)
        Anti-Polio 3; Day 455 /Day 425 (n=164)
    47.1 (37.1 to 59.9)
        Anti-Hep B; Day 455/Day 425 (n=167)
    55.1 (46.6 to 65.3)
        Anti-PRP; Day 455 /Day 425 (n=167)
    98.2 (78.8 to 122)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Seroprotection/Seroconversion Rates after Infant Series in Cohort 1 and Group 3 of A3L15 (U1111-1111-5789, NCT ID: NCT01105559, EudraCT number: 2011-004433-14)

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    End point title
    Percentage of Subjects With Seroprotection/Seroconversion Rates after Infant Series in Cohort 1 and Group 3 of A3L15 (U1111-1111-5789, NCT ID: NCT01105559, EudraCT number: 2011-004433-14)
    End point description
    Seroconversion defined as 4-fold increase in anti-PT & anti-FHA Ab concentrations from pre-vaccination to one month after first dose. Seroprotection defined as following: anti-Diphtheria & anti-Tetanus >=0.01 IU/mL; anti-PT & anti-FHA >=4EU/mL; anti-PRP >=0.15 mcg/mL; anti-Polio types 1, 2, & 3 >=8 (1/dilution), anti-Hepatitis B >=10 mIU/mL. Analysis performed on per protocol analysis set, which included subjects from Cohort 1 who received at least one dose of study vaccine & excluding those who had protocol deviations. Here, "n" signifies number of subjects with available data for each category.
    End point type
    Secondary
    End point timeframe
    Day 90 (1 month after third dose)
    End point values
    DTaP-IPV-HB-PRP~T Vaccine Group 3 A3L15
    Number of subjects analysed
    167
    123
    Units: percentage of subjects
    number (not applicable)
        Anti-Diphtheria; Day 90 (>=0.01 IU/mL) (n=163,122)
    99.4
    95.1
        Anti-Tetanus; Day 90 (>=0.01 IU/mL) (n=166,122)
    100.0
    100.0
        Anti-PRP; Day 90 (>=0.15 mcg/mL) (n=166,122)
    94.6
    97.5
        Anti-PT; Day 90 (>=4-fold rise EU/mL) (n=167,103)
    95.8
    95.1
        Anti-FHA; Day 90 (>=4-fold rise EU/mL) (n=167,90)
    96.4
    90.0
        Anti-Polio 1; Day 90 (>=8 [1/dil]) (n=163,104)
    100.0
    99.0
        Anti-Polio 2; Day 90 (>=8 [1/dil]) (n=164,113)
    100.0
    98.2
        Anti-Polio 3; Day 90 (>=8 [1/dil]) (n=166,98)
    100.0
    100.0
        Anti-Hep B; Day 90 (>=10 mIU/mL) (n=167,98)
    98.2
    99.0
    Statistical analysis title
    Non-inferiority analysis of anti-D antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 163).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    99.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    96.6
         upper limit
    100
    Statistical analysis title
    Non-inferiority analysis of anti-T antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 166).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    97.8
         upper limit
    100
    Statistical analysis title
    Non-inferiority analysis of anti-PRP antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 166).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    94.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    90
         upper limit
    97.5
    Statistical analysis title
    Non-inferiority analysis of anti-PRP antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 166).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    94.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    90
         upper limit
    97.5
    Statistical analysis title
    Non-inferiority analysis of anti-FHA antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 167).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    96.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    92.3
         upper limit
    98.7
    Statistical analysis title
    Non-inferiority analysis of antiPolio-1 antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 163).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    97.8
         upper limit
    100
    Statistical analysis title
    Non-inferiority analysis of antiPolio-2 antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 164).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    97.8
         upper limit
    100
    Statistical analysis title
    Non-inferiority analysis of antiPolio-3 antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 166).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    97.8
         upper limit
    100
    Statistical analysis title
    Non-inferiority analysis of anti-Hep B antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 167).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    98.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    94.8
         upper limit
    99.6
    Statistical analysis title
    Non-inferiority analysis of anti-D antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 122).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    95.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    89.6
         upper limit
    98.2
    Statistical analysis title
    Non-inferiority analysis of anti-T antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 122).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    97
         upper limit
    100
    Statistical analysis title
    Non-inferiority analysis of anti-PRP antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 122).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    97.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    93
         upper limit
    99.5
    Statistical analysis title
    Non-inferiority analysis of anti-PT antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 103).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    95.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    89
         upper limit
    98.4
    Statistical analysis title
    Non-inferiority analysis of anti-FHA antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 90).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    90
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    81.9
         upper limit
    95.3
    Statistical analysis title
    Non-inferiority analysis of antiPolio-1 antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 104).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    94.8
         upper limit
    100
    Statistical analysis title
    Non-inferiority analysis of antiPolio-2 antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 113).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    98.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    93.8
         upper limit
    99.8
    Statistical analysis title
    Non-inferiority analysis of antiPolio-3 antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 98).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    96.3
         upper limit
    100
    Statistical analysis title
    Non-inferiority analysis of anti-Hep B antibodies
    Statistical analysis description
    Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 98).
    Comparison groups
    DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage of subjects
    Point estimate
    99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    94.4
         upper limit
    100

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited reactions were collected up to Day 7 after each injection, non-serious unsolicited adverse events (AEs) were collected up to Day 30 after each injection, and serious AEs were collected throughout the study period.
    Adverse event reporting additional description
    Solicited reaction: AE prelisted in eCRF, considered related to vaccination. A solicited reaction was therefore, an adverse drug reaction observed, reported under conditions (nature and onset) prelisted in the eCRF. Unsolicited AE: an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    DTaP-IPV-HB-PRP~T Vaccine: Infant Series
    Reporting group description
    Subjects received 3 doses of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age.

    Reporting group title
    DTaP-IPV-HB-PRP~T Vaccine: Booster Vaccination
    Reporting group description
    Subjects received a booster dose of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, approximately 12 months after the completion of the Infant Series (at 16 to 17 months of age).

    Serious adverse events
    DTaP-IPV-HB-PRP~T Vaccine: Infant Series DTaP-IPV-HB-PRP~T Vaccine: Booster Vaccination
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 354 (4.52%)
    4 / 349 (1.15%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Congenital, familial and genetic disorders
    Cataract Congenital
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 349 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Influenza Like Illness
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 349 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    2 / 354 (0.56%)
    0 / 349 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Disorder
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 349 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis Acute
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 349 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 349 (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
    Bronchiolitis
         subjects affected / exposed
    2 / 354 (0.56%)
    0 / 349 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 349 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 349 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    2 / 354 (0.56%)
    0 / 349 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 354 (1.69%)
    1 / 349 (0.29%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 349 (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: 5%
    Non-serious adverse events
    DTaP-IPV-HB-PRP~T Vaccine: Infant Series DTaP-IPV-HB-PRP~T Vaccine: Booster Vaccination
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    301 / 354 (85.03%)
    137 / 349 (39.26%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    22 / 354 (6.21%)
    7 / 349 (2.01%)
         occurrences all number
    23
    8
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    141 / 354 (39.83%)
    25 / 349 (7.16%)
         occurrences all number
    202
    25
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    158 / 354 (44.63%)
    32 / 349 (9.17%)
         occurrences all number
    250
    32
    Injection Site Erythema
         subjects affected / exposed
    113 / 354 (31.92%)
    37 / 349 (10.60%)
         occurrences all number
    181
    37
    Injection Site Pain
         subjects affected / exposed
    205 / 354 (57.91%)
    83 / 349 (23.78%)
         occurrences all number
    360
    83
    Injection Site Swelling
         subjects affected / exposed
    47 / 354 (13.28%)
    29 / 349 (8.31%)
         occurrences all number
    85
    29
    Pyrexia
         subjects affected / exposed
    87 / 354 (24.58%)
    38 / 349 (10.89%)
         occurrences all number
    106
    39
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    119 / 354 (33.62%)
    45 / 349 (12.89%)
         occurrences all number
    200
    45
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    82 / 354 (23.16%)
    13 / 349 (3.72%)
         occurrences all number
    118
    13
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    108 / 354 (30.51%)
    53 / 349 (15.19%)
         occurrences all number
    148
    53

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2014
    • A brief presentation of the commercialization status of hexavalent vaccines in the world and the advantages of the Sanofi Pasteur’s hexavalent vaccine, if any, over other commercialized combined vaccines from Italy or United States was added in the Introduction section. • Since it was possible that the number of enrolled subjects was not achieved, the rule of three could be used in data analyses and this had been briefly explained. • Clarification on the fact that the insurance coverage cases at the end of study involvement for all subjects, with the exception of insurance coverage for subjects who reported an SAE during the trial that was determined to be related to study vaccines by the Investigator (insurance coverage was continued for these subjects until the SAE is resolved).
    25 Aug 2014
    • A booster dose was added to evaluate Ab persistence after 1 year. • A non-inferiority test comparing the immune response to all antigens induced by the study vaccine in Vietnam versus the response outside Vietnam was added. • The booster objective was added. • A booster endpoint was added.
    16 Feb 2016
    • A new Regional Director Of Medical Affairs was appointed. • The timelines were updated. • Clarification on the fact that reportable medications were to be collected in the CRF from the day of each vaccination up to the end of the safety follow-up, and that there was no collection between V4 and V5. • Restricted use therapies and non-authorized therapies were not to be collected anymore.
    07 Mar 2016
    Correction and clarification of the booster endpoints for PT and FHA were made.

    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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