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    Clinical Trial Results:
    Evaluation of Antibody Persistence Following a Primary Series at 2, 4, and 6 Months on Trial A3L24 and Booster Effect of the DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa® Concomitantly Administered with Prevenar® at 12 to 24 Months of Age in Healthy Latin American Infants

    Summary
    EudraCT number
    		 2011-004428-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Dec 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    27 Sep 2014
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A3L27
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01444781
    WHO universal trial number (UTN)
    		 U1111-1112-8473
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur S.A
    Sponsor organisation address
    1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
    Public contact
    Director, Clinical Development, Sanofi Pasteur S.A, 33 (0)4 37 37 58 43, emmanuel.feroldi@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur S.A, 33 (0)4 37 37 58 43, emmanuel.feroldi@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001201-PIP01-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity • To describe the antibody (Ab) persistence for all valences (except Prevenar [PCV7] and Rotarix), following a three-dose primary series vaccination, of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa at 2, 4 and 6 months of age • To describe the immunogenicity of a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa given at 12 to 24 months concomitantly with a booster dose of Prevenar (PCV7) • To describe the immunogenicity of a booster dose of Prevenar (PCV7) given at 12 to 24 months in the same subset of subjects that participated in the Prevenar (PCV7) immunogenicity analysis in A3L24 Study (maximum of 544 subjects) Safety To describe the safety profile after a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa given at 12 to 24 months of age concomitantly with a booster dose of Prevenar (PCV7)
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. 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
    		 Subjects randomized to the DTaP-IPV-Hep B-PRP-T vaccine included in Group 1 were to receive one of the 3 batches of this vaccine already used for the primary series trial A3L24 (same batch number as the one used in study A3L24). The subjects included in Group 2 (primed with DTaPIPV-Hep B-PRP-T vaccine) were to receive a booster dose of Infanrix hexa. The subjects included in the Group 3 (primed with Infanrix hexa) were to receive a DTaP-IPV-Hep B-PRP-T booster dose of one of the 3 batches used in study A3L24.
    Evidence for comparator
    		 Infanrix hexa was chosen as the comparator vaccine as it is currently the licensed hexavalent vaccine in Colombia and Costa Rica. Prevenar (PCV7) was to be co-administered with both the DTaP-IPV-Hep B-PRP-T and Infanrix hexa vaccines in order to document the effect of this co-administration. Prevenar vaccine is also licensed in Colombia and Costa Rica.
    Actual start date of recruitment
    26 Sep 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Colombia: 704
    Country: Number of subjects enrolled
    Costa Rica: 402
    Worldwide total number of subjects
    1106
    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)
    1106
    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
    		 The study participants were enrolled from 26 September 2011 through 19 July 2012 at 2 clinic centers in Colombia and Costa Rica.

    Pre-assignment
    Screening details
    		 A total of 1106 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    A blind-observer procedure was followed for the DTaP-IPV-Hep B-PRP-T/Infanrix hexa comparison so that neither the Investigator (who was in charge of the safety assessment), nor the subject (or his/her parent[s]/guardian[s]), nor the Sponsor knew which vaccine was administered. The product preparation and administration were performed by an unblinded individual and the assessment of safety was performed by a blinded individual in 2 different rooms.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster
    Arm description
    		 Subjects who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hexaxim
    Investigational medicinal product code
    DTaP-IPV-HepB-PRP-T vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, one primary dose series at 2, 4, and 6 months of age and a booster dose at 12 to 24 months of age.

    Arm title
    		 Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster
    Arm description
    		 Subjects who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hexaxim
    Investigational medicinal product code
    DTaP-IPV-HepB-PRP-T vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, one primary dose series at 2, 4, and 6 months of age.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, one booster dose at 12 to 24 months of age.

    Investigational medicinal product name
    Prevenar (PCV7)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, one booster dose coadministered with Infanrix hexa® at 12 to 24 months of age.

    Arm title
    		 Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Arm description
    		 Subjects who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hexaxim
    Investigational medicinal product code
    DTaP-IPV-HepB-PRP-T vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, one booster dose at 12 to 24 months of age.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, one primary dose series at 2, 4, and 6 months of age.

    Investigational medicinal product name
    Prevenar (PCV7)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, one booster dose coadministered with DTaP-IPV-Hep BPRP-T combined vaccine at 12 to 24 months of age.

    Number of subjects in period 1
    		Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Started
    416
    415
    275
    Completed
    413
    411
    272
    Not completed
    3
    4
    3
         Consent withdrawn by subject
    3
    1
    2
         Lost to follow-up
    -
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster
    Reporting group description
    		 Subjects who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)

    Reporting group title
    Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster
    Reporting group description
    		 Subjects who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7

    Reporting group title
    Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Reporting group description
    		 Subjects who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7

    Reporting group values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster Total
    Number of subjects
    		 416 415 275 1106
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 416 415 275 1106
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 17.6 ( 3.25 ) 17.6 ( 3.34 ) 17.8 ( 3.26 ) -
    Gender categorical
    Units: Subjects
        Female
    		 203 186 128 517
        Male
    		 213 229 147 589

    End points

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    End points reporting groups
    Reporting group title
    Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster
    Reporting group description
    		 Subjects who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)

    Reporting group title
    Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster
    Reporting group description
    		 Subjects who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7

    Reporting group title
    Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Reporting group description
    		 Subjects who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7

    Primary: Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine

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    End point title
    		 Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine [1]
    End point description
    Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers
    End point type
    Primary
    End point timeframe
    Day 140 (Primary series) and Day 0 (Pre-booster)
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    396
    393
    260
    Units: Subjects
    number (not applicable)
        Anti-Diphtheria Day140 ≥0.01 IU/mL
    392
    391
    259
        Anti-Diphtheria Day 140 ≥0.1 IU/mL
    308
    290
    197
        Anti-Diphtheria Day 0 ≥0.01 IU/mL
    382
    378
    246
        Anti-Diphtheria Day 0 ≥0.1 IU/mL
    156
    153
    70
        Anti-Diphtheria Day 30 ≥0.01 IU/mL
    393
    387
    254
        Anti-Diphtheria Day 30 ≥0.1 IU/mL
    393
    386
    254
        Anti-Tetanus Day 140 ≥0.01 IU/mL
    392
    391
    258
        Anti-Tetanus Day 140 ≥0.1 IU/mL
    392
    390
    258
        Anti-Tetanus Day 0 ≥0.01 IU/mL
    389
    386
    255
        Anti-Tetanus Day 0 ≥0.1 IU/mL
    289
    286
    196
        Anti-Tetanus Day 30 ≥0.01 IU/mL
    392
    385
    254
        Anti-Tetanus Day 30 ≥0.1 IU/mL
    391
    385
    254
    No statistical analyses for this end point

    Primary: Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

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    End point title
    		 Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine [2]
    End point description
    Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations < LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
    End point type
    Primary
    End point timeframe
    Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    396
    393
    260
    Units: Subjects
    number (not applicable)
        Anti-PT Day 140 ≥2 EU/mL
    393
    391
    259
        Anti-PT Day 0 ≥2 EU/mL
    344
    349
    225
        A-PT Day 30 ≥ 2 EU/mL
    391
    383
    254
        Anti-PT 4-fold increase
    353
    351
    234
        Anti-PT booster response
    375
    365
    245
        Anti-FHA Day 140 ≥2 EU/mL
    391
    390
    259
        Anti-FHA Day 0 ≥2 EU/mL
    389
    384
    253
        Anti-FHA Day 30 ≥2 EU/mL
    390
    385
    254
        Anti-FHA 4-fold increase
    336
    334
    235
        Anti-FHA booster response
    370
    367
    249
    No statistical analyses for this end point

    Primary: Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

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    End point title
    		 Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine [3]
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
    End point type
    Primary
    End point timeframe
    Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    396
    393
    260
    Units: Subjects
    number (not applicable)
        Anti-Polio 1 Day 140
    338
    329
    214
        Anti-Polio 1 Day 0
    334
    320
    210
        Anti-Polio 1 Day 30
    339
    327
    212
        Anti-Polio 2 Day 140
    338
    327
    214
        Anti-Polio 2 Day 0
    335
    328
    213
        Anti-Polio 2 Day 30
    340
    327
    212
        Anti-Polio 3 Day 140
    338
    328
    214
        Anti-Polio 3 Day 0
    324
    309
    211
        Anti-Polio 3 Day 30
    340
    326
    212
    No statistical analyses for this end point

    Primary: Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

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    End point title
    		 Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine [4]
    End point description
    Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
    End point type
    Primary
    End point timeframe
    Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    396
    393
    260
    Units: Subjects
    number (not applicable)
        Anti-Hep B Day 140 ≥10 mIU/mL
    391
    391
    260
        Anti-Hep B Day 140 ≥100 mIU/mL
    389
    387
    259
        Anti-Hep B Day 0 ≥10 mIU/mL
    386
    382
    257
        Anti-Hep B Day 0 ≥100 mIU/mL
    327
    333
    213
        Anti-Hep B Day 30 ≥10 mIU/mL
    394
    391
    259
        Anti-Hep B Day 30 ≥100 mIU/mL
    386
    384
    257
        Anti-PRP Day 140 ≥0.15 µg/mL
    370
    375
    246
        Anti-PRP Day 140 ≥1.0 µg/mL
    297
    305
    188
        Anti-PRP Day 0 ≥0.15 µg/mL
    290
    304
    197
        Anti-PRP Day 0 ≥1.0 µg/mL
    110
    129
    73
        Anti-PRP Day 30 ≥0.15 µg/mL
    395
    391
    258
        Anti-PRP Day 30 ≥1.0 µg/mL
    391
    387
    258
    No statistical analyses for this end point

    Secondary: Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

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    End point title
    		 Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
    End point description
    Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, anti-PT, and anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-PRP antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
    End point type
    Secondary
    End point timeframe
    Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    396
    393
    260
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Diphtheria Day 140
    0.265 (0.237 to 0.295)
    0.254 (0.227 to 0.285)
    0.251 (0.22 to 0.286)
        Anti-Diphtheria Day 0
    0.077 (0.069 to 0.086)
    0.074 (0.066 to 0.083)
    0.059 (0.051 to 0.068)
        Anti-Diphtheria Day 30
    5.55 (5.07 to 6.08)
    4.4 (3.99 to 4.86)
    6.05 (5.41 to 6.76)
        Anti-Tetanus Day 140
    1.5 (1.39 to 1.61)
    1.54 (1.44 to 1.65)
    1.8 (1.68 to 1.93)
        Anti-Tetanus Day 0
    0.208 (0.188 to 0.231)
    0.224 (0.2 to 0.251)
    0.201 (0.18 to 0.225)
        Anti-Tetanus Day 30
    5.72 (5.21 to 6.27)
    5.21 (4.78 to 5.68)
    7.52 (6.63 to 8.52)
        Anti-PT Day 140
    99.6 (94 to 106)
    102 (96.6 to 108)
    97 (90.1 to 105)
        Anti-PT Day 0
    7.43 (6.63 to 8.32)
    8.47 (7.52 to 9.56)
    7.41 (6.38 to 8.61)
        Anti PT Day 30
    154 (143 to 166)
    191 (178 to 206)
    140 (127 to 153)
        Anti-FHA Day 140
    179 (169 to 190)
    187 (176 to 199)
    120 (112 to 129)
        Anti-FHA Day 0
    21.2 (18.9 to 23.8)
    23.4 (20.8 to 26.3)
    14.4 (12.5 to 16.8)
        Anti-FHA Day 30
    316 (293 to 342)
    418 (386 to 454)
    260 (231 to 293)
        Anti-Polio 1 Day 140
    656 (587 to 734)
    705 (625 to 796)
    1276 (1098 to 1484)
        Anti-Polio 1 Day 0
    132 (116 to 150)
    134 (116 to 154)
    224 (188 to 267)
        Anti-Polio 1 Day 30
    2140 (1937 to 2364)
    2633 (2363 to 2933)
    2978 (2592 to 3421)
        Anti-Polio 2 Day 140
    1152 (1035 to 1282)
    1241 (1101 to 1398)
    1945 (1676 to 2256)
        Anti-Polio 2 Day 0
    251 (214 to 294)
    289 (245 to 341)
    380 (313 to 461)
        Anti-Polio 2 Day 30
    4232 (3821 to 4688)
    4887 (4372 to 5463)
    6369 (5569 to 7283)
        Anti-Polio 3 Day 140
    1169 (1025 to 1332)
    1108 (979 to 1255)
    1948 (1647 to 2304)
        Anti-Polio 3 Day 0
    128 (109 to 149)
    126 (106 to 150)
    207 (173 to 248)
        Anti-Polio 3 Day 30
    3569 (3164 to 4027)
    3322 (2939 to 3755)
    6015 (5244 to 6898)
        Anti-Hepatitis B Day 140
    3050 (2715 to 3427)
    3180 (2834 to 3568)
    2910 (2556 to 3313)
        Anti-Hepatitis B Day 0
    386 (332 to 449)
    406 (349 to 472)
    336 (284 to 397)
        Anti-Hepatitis B Day 30
    8462 (7154 to 10010)
    11218 (9482 to 13272)
    9688 (7940 to 11821)
        Anti-PRP Day 140
    3.19 (2.69 to 3.78)
    3.6 (3.05 to 4.25)
    2.13 (1.78 to 2.54)
        Ant-PRP Day 0
    0.482 (0.406 to 0.573)
    0.556 (0.472 to 0.656)
    0.455 (0.375 to 0.553)
        Anti-PRP Day 30
    42.4 (37 to 48.6)
    41.5 (36.6 to 47)
    56.5 (48.4 to 65.9)
    No statistical analyses for this end point

    Secondary: Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

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    End point title
    		 Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
    End point description
    Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Booster response to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F was defined as antibody titers ≥0.35 µg/mL at Day 30.
    End point type
    Secondary
    End point timeframe
    Day 30 after final booster vaccination
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    396
    393
    260
    Units: Subjects
    number (not applicable)
        Anti-Pneumococcal 4
    160
    146
    94
        Anti-Pneumococcal 6B
    155
    145
    93
        Anti-Pneumococcal 9V
    161
    147
    94
        Anti-Pneumococcal 14
    161
    147
    94
        Anti-Pneumococcal 18C
    160
    147
    94
        Anti-Pneumococcal 19F
    161
    144
    94
        Anti-Pneumococcal 23F
    158
    144
    93
    No statistical analyses for this end point

    Secondary: Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

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    End point title
    		 Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
    End point description
    Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA.
    End point type
    Secondary
    End point timeframe
    Day 30 after final booster vaccination
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    396
    393
    260
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Pneumococcal 4
    2.79 (2.47 to 3.15)
    3.03 (2.64 to 3.47)
    3.58 (3.07 to 4.17)
        Anti-Pneumococcal 6B
    6.87 (5.68 to 8.31)
    8.98 (7.86 to 10.3)
    9.34 (7.76 to 11.2)
        Anti-Pneumococcal 9V
    2.51 (2.22 to 2.85)
    2.86 (2.57 to 3.19)
    2.92 (2.5 to 3.42)
        Anti-Pneumococcal 14
    11.6 (10.2 to 13.2)
    13.2 (11.5 to 15.2)
    12.3 (10.2 to 14.7)
        Anti-Pneumococcal 18C
    2.37 (2.1 to 2.67)
    2.63 (2.35 to 2.95)
    3.4 (2.92 to 3.94)
        Anti-Pneumococcal 19F
    3.01 (2.62 to 3.47)
    3.74 (3.19 to 4.38)
    3.72 (3.19 to 4.32)
        Anti-Pneumococcal 23F
    6.98 (6.14 to 7.94)
    7.2 (6.23 to 8.33)
    9.3 (7.79 to 11.1)
    No statistical analyses for this end point

    Secondary: Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata

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    End point title
    		 Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata
    End point description
    Anti-PT and anti-FHA antibodies were measured by ELISA.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 after final booster vaccination
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    396
    393
    260
    Units: Subjects
    number (not applicable)
        Anti-PT ≥12 to <15 month Day 0
    100
    104
    61
        Anti-PT ≥12 to <15 moth Day 30 4-fold
    87
    92
    53
        Anti-PT ≥12 to <15 months Booster
    100
    99
    56
        Anti-PT ≥15 to <19 month Day 0
    133
    118
    86
        Anti-PT ≥15 to <19 moth Day 30 4-fold
    132
    121
    89
        Anti-PT ≥15 to <19 month Booster
    138
    125
    94
        Anti-PT ≥19 to ≤24 months Day 0
    111
    127
    78
        AntiPT ≥19 to ≤24 month Day 30 4 fold
    134
    138
    92
        Anti-PT ≥19 to ≤24 months Booster
    136
    141
    95
        Anti-FHA ≥12 to <15 months Day 0
    103
    105
    59
        Anti-FHA ≥12 to <15 mos Day 30 4-fold
    76
    78
    53
        Anti-FHA ≥12 to <15 months Booster
    96
    99
    58
        Anti-FHA ≥15 to <19 month Day 0
    143
    130
    95
        Anti-FHA ≥15 to <19 mos Day 30 4-fold
    127
    118
    88
        Anti-FHA ≥15 to <19 months Booster
    136
    124
    94
        Anti-FHA ≥19 to ≤24 month Day 0
    143
    149
    99
        Anti-FHA ≥19 to ≤24 mos Day 30 4-fold
    133
    138
    94
        Anti-FHA ≥19 to ≤ 24 months Booster
    138
    144
    97
    No statistical analyses for this end point

    Secondary: Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata

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    End point title
    		 Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata
    End point description
    Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
    End point type
    Secondary
    End point timeframe
    Day 30 after final booster vaccination
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    396
    393
    260
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Diphtheria ≥12 to <15 months
    3.2 (2.72 to 3.76)
    2.73 (2.3 to 3.24)
    3.82 (3.01 to 4.84)
        Anti-Diphtheria ≥15 to <19 months
    6.39 (5.56 to 7.34)
    4.77 (3.98 to 5.72)
    6.56 (5.43 to 7.92)
        Anti-Diphtheria ≥19 to ≤24 months
    7.14 (6.17 to 8.26)
    5.77 (5 to 6.66)
    7.34 (6.3 to 8.56)
        Anti-FHA ≥12 to <15 months
    235 (209 to 263)
    268 (233 to 308)
    197 (156 to 248)
        Anti-FHA ≥15 to <19 months
    339 (294 to 392)
    453 (392 to 524)
    280 (236 to 331)
        Anti-FHA ≥19 to ≤24 months
    365 (322 to 414)
    533 (473 to 599)
    287 (232 to 356)
        Anti-Polio 3 ≥12 to <15 months
    2509 (1944 to 3240)
    2616 (2098 to 3263)
    5617 (4006 to 7876)
        Anti-Polio 3 ≥15 to <19 months
    3944 (3265 to 4764)
    3261 (2585 to 4113)
    5409 (4359 to 6713)
        Anti-Polio 3 ≥19 to ≤24 months
    4119 (3398 to 4993)
    4061 (3387 to 4869)
    6889 (5583 to 8499)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

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    End point title
    		 Number of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
    End point description
    Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb; Solicited systemic reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Injection site: Pain, Cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; Extensive swelling of limb, Severe. Grade 3 Systemic reactions: Pyrexia (Temperature) >39.5˚C; Vomiting, ≥ 6 times per 24 hours or needing parenteral nutrition; Crying, >3 hours; Somnolence, Sleeping often or difficulty waking; Anorexia, refuses ≥3 meals; and Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 after final booster vaccination
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    416
    415
    275
    Units: Subjects
    number (not applicable)
        Injection site Pain
    232
    205
    160
        Grade 3 inj. site Pain
    10
    6
    6
        Injection site Erythema
    112
    100
    86
        Grade 3 inj. site Erythema
    4
    3
    7
        Injection site Swelling
    60
    56
    49
        Grade 3 inj. site Swelling
    3
    3
    1
        Extensive swelling of limb
    0
    0
    0
        Grade 3 Extensive swelling of limb
    0
    0
    0
        Pyrexia
    114
    99
    91
        Grade 3 Pyrexia
    2
    6
    1
        Vomiting
    34
    39
    19
        Grade 3 Vomiting
    1
    1
    0
        Crying
    148
    139
    102
        Grade 3 Crying
    1
    1
    2
        Somnolence
    124
    113
    85
        Grade 3 Somnolence
    2
    1
    2
        Anorexia
    118
    121
    90
        Grade 3 Anorexia
    3
    3
    4
        Irritability
    201
    176
    146
        Grade 3 Irritability
    1
    3
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine

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    End point title
    		 Number of Subjects Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine
    End point description
    Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Grade 3 Injection site: Pain, cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; and Extensive swelling of limb, Severe.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 after final booster vaccination
    End point values
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Number of subjects analysed
    416
    415
    275
    Units: Subjects
    number (not applicable)
        Injection site Pain
    224
    184
    140
        Grade 3 Injection site Pain
    9
    9
    5
        Injection site Erythema
    84
    77
    52
        Grade 3 Injection site Erythema
    0
    0
    0
        Injection site Swelling
    51
    42
    33
        Grade 3 Injection site Swelling
    1
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination.
    Adverse event reporting additional description
    The total number (N) for solicited adverse events in the table reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster
    Reporting group description
    		 Subjects who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)

    Reporting group title
    Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster
    Reporting group description
    		 Subjects who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7

    Reporting group title
    Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Reporting group description
    		 Subjects who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7

    Serious adverse events
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 416 (3.13%)
    15 / 415 (3.61%)
    9 / 275 (3.27%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    2 / 416 (0.48%)
    2 / 415 (0.48%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 415 (0.24%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 415 (0.00%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 416 (0.48%)
    1 / 415 (0.24%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 415 (0.24%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthropathy
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 415 (0.24%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 415 (0.24%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 415 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 415 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kawasaki's disease
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 415 (0.00%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 415 (0.24%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 416 (1.20%)
    4 / 415 (0.96%)
    5 / 275 (1.82%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 415 (0.24%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 415 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 416 (0.00%)
    2 / 415 (0.48%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 415 (0.24%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    253 / 416 (60.82%)
    221 / 415 (53.25%)
    168 / 275 (61.09%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    124 / 413 (30.02%)
    113 / 412 (27.43%)
    85 / 272 (31.25%)
         occurrences all number
    124
    113
    85
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    232 / 416 (55.77%)
    205 / 412 (49.76%)
    160 / 272 (58.82%)
         occurrences all number
    232
    205
    160
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    112 / 413 (27.12%)
    100 / 412 (24.27%)
    86 / 272 (31.62%)
         occurrences all number
    112
    100
    86
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    60 / 412 (14.56%)
    56 / 412 (13.59%)
    49 / 272 (18.01%)
         occurrences all number
    60
    56
    49
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    114 / 413 (27.60%)
    99 / 412 (24.03%)
    91 / 272 (33.46%)
         occurrences all number
    114
    99
    91
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    34 / 413 (8.23%)
    39 / 412 (9.47%)
    19 / 272 (6.99%)
         occurrences all number
    34
    39
    19
    Psychiatric disorders
    Crying
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    148 / 413 (35.84%)
    139 / 412 (33.74%)
    102 / 272 (37.50%)
         occurrences all number
    148
    139
    102
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    201 / 413 (48.67%)
    176 / 412 (42.72%)
    146 / 272 (53.68%)
         occurrences all number
    201
    176
    146
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    27 / 416 (6.49%)
    23 / 415 (5.54%)
    12 / 275 (4.36%)
         occurrences all number
    27
    23
    12
    Metabolism and nutrition disorders
    Anorexia
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    118 / 413 (28.57%)
    121 / 412 (29.37%)
    90 / 272 (33.09%)
         occurrences all number
    118
    121
    90
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) for solicited adverse events in the table reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) for solicited adverse events in the table reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) for solicited adverse events in the table reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) for solicited adverse events in the table reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) for solicited adverse events in the table reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) for solicited adverse events in the table reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) for solicited adverse events in the table reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) for solicited adverse events in the table reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) for solicited adverse events in the table reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jun 2011
    Protocol was amended to add measles, mumps, rubella and varicella, and yellow fever vaccinations and to take into account the National Campaign of Intensification against polio in Costa Rica.
    06 Oct 2011
    A 5th dose of a pneumococcal conjugate vaccine (administered after completing V02 and at least one month after the PCV7 booster dose) was added by using the 13-valent PCV as result of a change of the National Vaccination calendar in Costa Rica.
    17 Sep 2012
    The principal Investigator was changed in Costa Rica.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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