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    Clinical Trial Results:
    A phase IIIa open, randomised, controlled study to assess the safety, reactogenicity and immunogenicity induced by a booster dose of GlaxoSmithKline (GSK) Biologicals 10-valent pneumococcal conjugate vaccine when co-administered with GSK Biologicals’ measles-mumps-rubella-varicella vaccine (MMRV) vaccine in children during their second year of life, previously vaccinated in infancy in the primary study 10PN-PD-DIT-001 (105553) with GSK Biologicals 10-valent pneumococcal conjugate vaccine.

    Summary
    EudraCT number
    		 2006-001934-42
    Trial protocol
    		 FI  
    Global end of trial date
    21 Dec 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Mar 2016
    First version publication date
    29 Apr 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    107706
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00370227
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.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 Jan 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the incidence of post-immunization rectal fever >39.0°C following a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with the first dose of MMRV vaccine in children 12 to 14 months of age.
    Protection of trial subjects
    All subjects were supervised after vaccination administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. In addition , careful assessment of subjects was performed as regards the following: risk of/ contraindication to further vaccination with DTPa-HBV-IPV/Hib and MMRV vaccines. Concerning the DTPa-HBV-IPV/Hib vaccine, occurrences of encephalopathy within 7 days from vaccination and of fever (rectally) equal or higher than 40.5°C within 48 hours of vaccination were closely followed up. Concerning the MMRV vaccine, since it is recommended that members of the investigational team and subjects’ environment be as much as possible immune to varicella, the presence of a susceptible high-risk person (e.g., newborns between 0-4 weeks old, pregnant women with negative history of chickenpox and without recorded vaccination against chickenpox, immunocompromised persons including those with HIV) in the same household as the subject during the study period was considered as an exclusion criteria. It was also recommended that this information be given to the parents/guardians such that, in the advent of a member of the household becoming high-risk within the period of the study, vaccine recipients and especially those who may develop a vaccine-associated rash would avoid close association with these susceptible high-risk individuals. In such circumstances, the potential risk of transmission of the attenuated virus present in the vaccine was to be weighed against the risk of infection and subsequent transmission of natural varicella by individuals who did not benefit from vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Oct 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 4 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 325
    Worldwide total number of subjects
    325
    EEA total number of subjects
    325
    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)
    325
    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 included an Active Phase (Days 0 to 84-112 for 10Pn-MMRV & DTPa-HBV-IPV/Hib-MMRV groups and Days 0 to 42-56 for 10Pn-DTPa-HBV-IPV/Hib Group), & an Extended Safety Follow-Up (ESFU) Phase of up to 4 months duration (til 20-22 months of age [MoA] for 10Pn-MMRV & DTPa-HBV-IPV/Hib-MMRV groups & til 18-20 MoA for 10Pn-DTPa-HBV-IPV/Hib Group).

    Pre-assignment
    Screening details
    		 Screening checks included checks on inclusion/exclusion criteria, contraindications/precautions and subjects’ medical history. Parent(s)/guardian(s) of subjects signed informed consent forms. Risk impact from fever (rectally) >= 38.0°C and/or >= 40.5°C prior to vaccination and for high risk persons for varicella in the same household were evaluated

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 10Pn-MMRV Group
    Arm description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the 2nd dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of 10Pn vaccine co-administered with the 1st dose of Priorix-Tetra™ (or MMRV vaccine), and, at 14 to 16 months of age, the 2nd dose of MMRV vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the left thigh or deltoid and the MMRV vaccine subcutaneously in the right deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10 valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, Synflorix™ (by GSK Biologicals)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One booster dose administered intramuscularly at 12-14 months of age in the left thigh or deltoid

    Investigational medicinal product name
    Priorix-Tetra™
    Investigational medicinal product code
    Other name
    MMRV vaccine; GSK Biologicals’ combined measles–mumps-rubella-varicella vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously in the right deltoid at 12-14 and at 14-16 months of age.

    Investigational medicinal product name
    DTPa-HBV-IPV/Hib
    Investigational medicinal product code
    Other name
    Infanrix hexa™ (by GSK Biologicals)
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly at 14-16 months of age in the left thigh or deltoid.

    Arm title
    		 DTPa-HBV-IPV/Hib-MMRV Group
    Arm description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In the 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the 2nd dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of DTPa-HBV-IPV/Hib vaccine co-administered with the 1st dose of Priorix-Tetra™ (or MMRV vaccine), and, at 14 to 16 months of age, the 2nd dose of MMRV vaccine co-administered with a booster dose of 10Pn vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the left thigh or deltoid and the MMRV vaccine subcutaneously in the right deltoid.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    10 valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, Synflorix™ (by GSK Biologicals)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One booster dose administered at 14-16 months of age in the left thigh or deltoid

    Investigational medicinal product name
    Priorix-Tetra™
    Investigational medicinal product code
    Other name
    MMRV vaccine; GSK Biologicals’ combined measles–mumps-rubella-varicella vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously in the right deltoid at 12-14 and at 14-16 months of age.

    Investigational medicinal product name
    DTPa-HBV-IPV/Hib
    Investigational medicinal product code
    Other name
    Infanrix hexa™ (by GSK Biologicals)
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly at 12-14 months of age in the left thigh or deltoid.

    Arm title
    		 10Pn-DTPa-HBV-IPV/Hib Group
    Arm description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In the 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of 10Pn vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the thigh or deltoid, respectively in the left and right side.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    10 valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, Synflorix™ (by GSK Biologicals)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One booster dose administered at 14-16 months of age in the left thigh or deltoid

    Investigational medicinal product name
    DTPa-HBV-IPV/Hib
    Investigational medicinal product code
    Other name
    Infanrix hexa™ (by GSK Biologicals)
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly at 12-14 months of age in the right thigh or deltoid.

    Number of subjects in period 1
    		10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Started
    110
    101
    114
    Completed
    108
    100
    111
    Not completed
    2
    1
    3
         Consent withdrawn by subject
    1
    1
    2
         Lost to follow-up
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    10Pn-MMRV Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the 2nd dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of 10Pn vaccine co-administered with the 1st dose of Priorix-Tetra™ (or MMRV vaccine), and, at 14 to 16 months of age, the 2nd dose of MMRV vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the left thigh or deltoid and the MMRV vaccine subcutaneously in the right deltoid.

    Reporting group title
    DTPa-HBV-IPV/Hib-MMRV Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In the 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the 2nd dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of DTPa-HBV-IPV/Hib vaccine co-administered with the 1st dose of Priorix-Tetra™ (or MMRV vaccine), and, at 14 to 16 months of age, the 2nd dose of MMRV vaccine co-administered with a booster dose of 10Pn vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the left thigh or deltoid and the MMRV vaccine subcutaneously in the right deltoid.

    Reporting group title
    10Pn-DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In the 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of 10Pn vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the thigh or deltoid, respectively in the left and right side.

    Reporting group values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group Total
    Number of subjects
    		 110 101 114 325
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 12.3 ( 0.48 ) 12.3 ( 0.5 ) 12.3 ( 0.52 ) -
    Gender categorical
    Units: Subjects
        Female
    		 49 52 65 166
        Male
    		 61 49 49 159

    End points

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    End points reporting groups
    Reporting group title
    10Pn-MMRV Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the 2nd dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of 10Pn vaccine co-administered with the 1st dose of Priorix-Tetra™ (or MMRV vaccine), and, at 14 to 16 months of age, the 2nd dose of MMRV vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the left thigh or deltoid and the MMRV vaccine subcutaneously in the right deltoid.

    Reporting group title
    DTPa-HBV-IPV/Hib-MMRV Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In the 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the 2nd dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of DTPa-HBV-IPV/Hib vaccine co-administered with the 1st dose of Priorix-Tetra™ (or MMRV vaccine), and, at 14 to 16 months of age, the 2nd dose of MMRV vaccine co-administered with a booster dose of 10Pn vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the left thigh or deltoid and the MMRV vaccine subcutaneously in the right deltoid.

    Reporting group title
    10Pn-DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In the 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of 10Pn vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the thigh or deltoid, respectively in the left and right side.

    Primary: Number of subjects with fever as solicited general symptom

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    End point title
    		 Number of subjects with fever as solicited general symptom [1]
    End point description
    Fever as solicited general symptom was defined as rectal temperature above 39.0 degrees centigrade (°C).
    End point type
    Primary
    End point timeframe
    Within 15 days (Day 0-14) post vaccination with Dose 1 (D1) (= booster dose of 10Pn and the first dose of MMRV vaccine)
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    109
    101
    112
    Units: Subjects
        Fever (>39.0°C), post D1 (N=109;101;112)
    31
    33
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects with any and grade 3 solicited local symptoms
    End point description
    Solicited local symptoms assessed were pain, redness and swelling at the injection site (in MedDRA terms: injection site pain, redness and swelling). Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Days 0-3) post vaccination, across doses
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    109
    101
    112
    Units: Subjects
        Any Pain, Across doses (N=109;101;112)
    69
    50
    73
        Grade 3 Pain, Across doses (N=109;101;112)
    6
    0
    4
        Any Redness, Across doses (N=109;101;112)
    79
    75
    70
        Grade 3 Redness, Across doses (N=109;101;112)
    13
    7
    7
        Any Swelling, Across doses (N=109;101;112)
    58
    57
    52
        Grade 3 Swelling, Across doses (N=109;101;112)
    16
    9
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with any and Grade 3 solicited general symptoms

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    End point title
    		 Number of subjects with any and Grade 3 solicited general symptoms
    End point description
    Solicited general symptoms assessed were drowsiness (Drows), irritability (Irr) and loss of appetite (Loss App). Grade 3 (G3) Drows was defined as drowsiness that prevented normal activity. G3 Irr was defined as crying that could not be comforted/which prevented normal activity. G3 Loss App was defined as not eating at all. Any was defined as incidence of the specified symptom regardless of intensity/relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Days 0-3) post vaccination, across doses
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    109
    101
    112
    Units: Subjects
        Any Drows, Across doses (N=109;101;112)
    55
    54
    57
        G3 Drows, Across doses (N=109;101;112)
    0
    0
    0
        Any Irr, Across doses (N=109;101;112)
    80
    73
    84
        G3 Irr, Across doses (N=109;101;112)
    4
    1
    5
        Any Loss App, Across doses (N=109;101;112)
    47
    33
    37
        G3 Loss App, Across doses (N=109;101;112)
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with any and Grade 3 solicited general symptoms specific to MMRV vaccination

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    End point title
    		 Number of subjects with any and Grade 3 solicited general symptoms specific to MMRV vaccination
    End point description
    Solicited general symptoms assessed were fever (as solicited general symptom following MMRV vaccination defined as rectal temperature higher than or equal to [≥] 38.0 degrees centigrade [°C]), rash (or exanthema) (referred to as ‘rash’ below), parotid/ salivary gland swelling (referred to as ‘parotid gland’ below), and any suspected signs of meningism including febrile convulsions (referred to as ‘meningism’ below). G3 fever was defined as rectal temperature higher than (>) 40.0°C, G3 meningism as meningism which prevented normal, everyday activity, G3 parotid gland as swelling with accompanying symptoms and G3 rash as subject presenting ≥ 150 lesions. Any was defined as incidence of the specified symptom regardless of intensity/relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Days 0-42) post vaccination, across doses
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    109
    101
    112
    Units: Subjects
        Any Fever (>=38.0°C), across doses (N=109;101;112)
    101
    88
    69
        G3 Fever (> 40.0°C), across doses (N=109;101;112)
    6
    6
    4
        Any Meningism, across doses (N=109;101;112)
    0
    0
    1
        G3 Meningism, across doses (N=109;101;112)
    0
    0
    1
        Any Parotid Gland, across doses (N=109;101;112)
    0
    0
    0
        G3 Parotid Gland, across doses (N=109;101;112)
    0
    0
    0
        Any Rash, across doses (N=109;101;112)
    38
    48
    18
        G3 Rash, across doses (N=109;101;112)
    8
    11
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Days 0-42) post vaccination, across doses
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    110
    101
    114
    Units: Subjects
        Any unsolicited AEs
    88
    80
    78
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs) during the Active Phase of the study, for subjects in 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups

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    End point title
    		 Number of subjects with serious adverse events (SAEs) during the Active Phase of the study, for subjects in 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups [2]
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity . The endpoint only concerns subjects in 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups, for whom the Active Phase of the study ended at Day 86-112.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 86-112 (from 12-14 to 16-18 months of age for subjects)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    110
    101
    Units: Subjects
        Any SAE(s)
    2
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs) during the Active Phase of the study, for subjects in 10Pn-DTPa-HBV-IPV/Hib Group

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    End point title
    		 Number of subjects with serious adverse events (SAEs) during the Active Phase of the study, for subjects in 10Pn-DTPa-HBV-IPV/Hib Group [3]
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity . The endpoint only concerns subjects in 10Pn-DTPa-HBV-IPV/Hib Group, for whom the Active Phase of the study ended at Day 42-56.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 42-56 (from 12-14 to 14-16 months of age for subjects)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-DTPa-HBV-IPV/Hib Group
    End point values
    		 10Pn-DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    114
    Units: Subjects
        Any SAE(s)
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs) throughout the entire study

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    End point title
    		 Number of subjects with serious adverse events (SAEs) throughout the entire study
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity . Please note that this endpoint was analysed only in subjects participating to the ESFU Phase (that is, 108, 100 and 111 subjects in the 10Pn-MMRV, DTPa-HBV-IPV/Hib-MMRV and 10Pn-DTPa-HBV-IPV/Hib Groups, respectively).
    End point type
    Secondary
    End point timeframe
    Throughout the entire study, e. a. during the Active and ESFU phases of the study (from Day 0 to Day 222-266 for 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups, and to Day 180-210 for 10Pn-DTPa-HBV-IPV/Hib Group)
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    108
    100
    111
    Units: Subjects
        Any SAE(s)
    5
    3
    4
    No statistical analyses for this end point

    Secondary: Number of subjects with seroprotective levels of antibodies against anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antigens

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    End point title
    		 Number of subjects with seroprotective levels of antibodies against anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antigens [4]
    End point description
    A subject with seroprotective levels of antibodies against pneumococcal serotypes1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antigens was defined as a subject with anti-pneumococcal serotype antibody concentration above than or equal to (≥) 0.20 microgram per millilitre (μg/mL). Anti-pneumococcal serotypes antibodies assessed were antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using ≥0.05 μg/mL as seropositivity cut off. This endpoint was assessed solely in the 10Pn-MMRV and 10Pn-DTPa-HBV-IPV/Hib groups.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and Day 42 (Day 42-56 after booster vaccination with 10Pn/1st Dose MMRV)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and 10Pn-DTPa-HBV-IPV/Hib groups.
    End point values
    		 10Pn-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    108
    110
    Units: Subjects
        Anti-1 , PRE (N=107;110)
    47
    62
        Anti-1 , Day 42 (N=104;106)
    103
    104
        Anti-4 , PRE (N=106;110)
    74
    88
        Anti-4 , Day 42 (N=104;106)
    104
    106
        Anti-5 , PRE (N=106;110)
    81
    95
        Anti-5 , Day 42 (N=104;106)
    104
    105
        Anti-6B , PRE (N=106;110)
    77
    86
        Anti-6B , Day 42 (N=104;106)
    100
    99
        Anti-7F , PRE (N=108;110)
    103
    107
        Anti-7F , Day 42 (N=104;106)
    104
    106
        Anti-9V , PRE (N=106;110)
    101
    104
        Anti-9V , Day 42 (N=104;106)
    104
    105
        Anti-14 , PRE (N=107;110)
    102
    105
        Anti-14 , Day 42 (N=104;106)
    103
    106
        Anti-18C , PRE (N=107;110)
    81
    97
        Anti-18C , Day 42 (N=104;106)
    104
    106
        Anti-19F , PRE (N=106;110)
    87
    95
        Anti-19F , Day 42 (N=104;106)
    101
    104
        Anti-23F , PRE (N=106;110)
    68
    88
        Anti-23F , Day 42 (N=104;106)
    101
    100
    No statistical analyses for this end point

    Secondary: Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F).

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    End point title
    		 Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). [5]
    End point description
    Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean concentrations (GMCs), in microgram per millilitre (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. This endpoint was assessed solely in the 10Pn-MMRV and 10Pn-DTPa-HBV-IPV/Hib groups.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and Day 42 (Day 42-56 after booster vaccination with 10Pn/1st Dose MMRV)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and 10Pn-DTPa-HBV-IPV/Hib groups.
    End point values
    		 10Pn-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    108
    110
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 , PRE (N=107;110)
    0.17 (0.15 to 0.21)
    0.21 (0.18 to 0.25)
        Anti-1 , Day 42 (N=104;106)
    1.11 (0.96 to 1.28)
    1.15 (0.98 to 1.34)
        Anti-4 , PRE (N=106;110)
    0.33 (0.27 to 0.39)
    0.43 (0.36 to 0.51)
        Anti-4 , Day 42 (N=104;106)
    2.11 (1.83 to 2.42)
    1.98 (1.72 to 2.27)
        Anti-5 , PRE (N=106;110)
    0.33 (0.28 to 0.39)
    0.33 (0.28 to 0.39)
        Anti-5 , Day 42 (N=104;106)
    1.61 (1.36 to 1.89)
    1.61 (1.36 to 1.89)
        Anti-6B , PRE (N=106;110)
    0.33 (0.27 to 0.41)
    0.37 (0.3 to 0.45)
        Anti-6B , Day 42 (N=104;106)
    1.42 (1.17 to 1.73)
    1.34 (1.07 to 1.69)
        Anti-7F , PRE (N=108;110)
    0.77 (0.66 to 0.89)
    0.94 (0.82 to 1.08)
        Anti-7F , Day 42 (N=104;106)
    2.94 (2.62 to 3.3)
    3.43 (3.04 to 3.87)
        Anti-9V , PRE (N=106;110)
    0.64 (0.56 to 0.74)
    0.8 (0.68 to 0.94)
        Anti-9V , Day 42 (N=104;106)
    2.33 (2.05 to 2.65)
    2.56 (2.25 to 2.92)
        Anti-14 , PRE (N=107;110)
    1.13 (0.93 to 1.37)
    1.27 (1.05 to 1.54)
        Anti-14 , Day 42 (N=104;106)
    4.18 (3.53 to 4.97)
    4.32 (3.73 to 5.01)
        Anti-18C , PRE (N=107;110)
    0.38 (0.32 to 0.45)
    0.54 (0.45 to 0.64)
        Anti-18C , Day 42 (N=104;106)
    4.14 (3.66 to 4.68)
    3.99 (3.53 to 4.52)
        Anti-19F , PRE (N=106;110)
    0.53 (0.42 to 0.66)
    0.7 (0.56 to 0.87)
        Anti-19F , Day 42 (N=104;106)
    4.23 (3.4 to 5.27)
    3.62 (3.03 to 4.32)
        Anti-23F , PRE (N=106;110)
    0.34 (0.27 to 0.43)
    0.46 (0.36 to 0.6)
        Anti-23F , Day 42 (N=104;106)
    1.68 (1.36 to 2.08)
    1.65 (1.34 to 2.04)
    No statistical analyses for this end point

    Secondary: Antibody concentrations to protein D

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    End point title
    		 Antibody concentrations to protein D [6]
    End point description
    Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. This endpoint was assessed solely in the 10Pn-MMRV and 10Pn-DTPa-HBV-IPV/Hib groups.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and Day 42 (Day 42-56 after booster vaccination with 10Pn/1st Dose MMRV)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and 10Pn-DTPa-HBV-IPV/Hib groups.
    End point values
    		 10Pn-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    108
    108
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD, PRE (N= 108;108)
    594.8 (490.7 to 720.8)
    717.6 (582 to 884.7)
        Anti-PD, Day 42 (N=104;106 )
    2655.8 (2123.9 to 3320.8)
    2666 (2190.1 to 3245.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with seroprotective levels of antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antigens

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    End point title
    		 Number of subjects with seroprotective levels of antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antigens [7]
    End point description
    A subject with seroprotective levels of antibodies against pneumococcal serotypes1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antigens was defined as a subject with anti-pneumococcal serotype antibody concentration above than or equal to (≥) 0.20 microgram per millilitre (μg/mL). Anti-pneumococcal serotypes antibodies assessed were antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using ≥ 0.05 μg/mL as seropositivity cut off. This endpoint was assessed solely in the DTPa-HBV-IPV/Hib-MMRV Group.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and Day 84 (Day 42-56 after 2nd dose MMRV)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the DTPa-HBV-IPV/Hib-MMRV Group
    End point values
    		 DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    93
    Units: Subjects
        Anti-1 , PRE (N=92)
    45
        Anti-1 , Day 84 (N=91)
    88
        Anti-4 , PRE (N=92)
    72
        Anti-4 , Day 84 (N=91)
    91
        Anti-5 , PRE (N=92)
    78
        Anti-5 , Day 84 (N=91)
    91
        Anti-6B , PRE (N=92)
    81
        Anti-6B , Day 84 (N=91)
    87
        Anti-7F , PRE (N=91)
    89
        Anti-7F , Day 84 (N=91)
    91
        Anti-9V , PRE (N=92)
    83
        Anti-9V , Day 84 (N=91)
    91
        Anti-14 , PRE (N=92)
    85
        Anti-14 , Day 84 (N=91)
    91
        Anti-18C , PRE (N=93)
    77
        Anti-18C , Day 84 (N=91)
    90
        Anti-19F , PRE (N=93)
    81
        Anti-19F , Day 84 (N=91)
    91
        Anti-23F , PRE (N=92)
    72
        Anti-23F , Day 84 (N=91)
    90
    No statistical analyses for this end point

    Secondary: Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F).

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    End point title
    		 Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). [8]
    End point description
    Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean concentrations (GMCs), in microgram per millilitre (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. This endpoint was assessed solely in the DTPa-HBV-IPV/Hib-MMRV Group.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and Day 84 (Day 84-56 after 2nd dose MMRV)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the DTPa-HBV-IPV/Hib-MMRV Group.
    End point values
    		 DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    93
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 , PRE (N=92)
    0.19 (0.16 to 0.24)
        Anti-1 , Day 84 (N=91)
    1.24 (1.04 to 1.49)
        Anti-4 , PRE (N=92)
    0.47 (0.38 to 0.59)
        Anti-4 , Day 84 (N=91)
    2.54 (2.16 to 2.98)
        Anti-5 , PRE (N=92)
    0.45 (0.38 to 0.53)
        Anti-5 , Day 84 (N=91)
    1.93 (1.61 to 2.32)
        Anti-6B , PRE (N=92)
    0.51 (0.4 to 0.65)
        Anti-6B , Day 84 (N=91)
    1.63 (1.31 to 2.01)
        Anti-7F , PRE (N=91)
    0.83 (0.71 to 0.98)
        Anti-7F , Day 84 (N=91)
    2.93 (2.55 to 3.36)
        Anti-9V , PRE (N=92)
    0.72 (0.59 to 0.87)
        Anti-9V , Day 84 (N=91)
    2.6 (2.21 to 3.06)
        Anti-14 , PRE (N=92)
    1.21 (0.93 to 1.57)
        Anti-14 , Day 84 (N=91)
    4.19 (3.5 to 5.01)
        Anti-18C , PRE (N=93)
    0.46 (0.38 to 0.56)
        Anti-18C , Day 84 (N=91)
    2.74 (2.3 to 3.26)
        Anti-19F , PRE (N=93)
    0.68 (0.54 to 0.86)
        Anti-19F , Day 84 (N=91)
    3.94 (3.33 to 4.67)
        Anti-23F , PRE (N=92)
    0.47 (0.38 to 0.58)
        Anti-23F , Day 84 (N=91)
    2.41 (2.03 to 2.85)
    No statistical analyses for this end point

    Secondary: Antibody concentrations to protein D

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    End point title
    		 Antibody concentrations to protein D [9]
    End point description
    Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was >= 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. This endpoint was assessed solely in the DTPa-HBV-IPV/Hib-MMRV Group
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and Day 84 (Day 84-56 after 2nd dose MMRV)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-DTPa-HBV-IPV/Hib Group
    End point values
    		 DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    91
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD, PRE
    690.2 (545.2 to 873.7)
        Anti-PD, Day 84
    3346.1 (2580.8 to 4338.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with seropositive levels of antibodies against mumps antigens

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    End point title
    		 Number of subjects with seropositive levels of antibodies against mumps antigens [10]
    End point description
    A subject with seropositive levels of antibodies against mumps antigens (S+ Mumps) was defined as a subject with anti-mumps antibody concentrations ≥ 231 units per millilitre (U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    102
    88
    Units: Subjects
        S+ Mumps, Day 42 (N=102;88)
    92
    79
        S+ Mumps, Day 84 (N=102;89)
    99
    89
    No statistical analyses for this end point

    Secondary: Number of subjects with seropositive levels of antibodies against rubella antigens

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    End point title
    		 Number of subjects with seropositive levels of antibodies against rubella antigens [11]
    End point description
    A subject with seropositive levels of antibodies against rubella antigens (S+ Rubella) was defined as a subject with anti-rubella antibody concentrations ≥ 4 international units per millilitre (IU/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    102
    89
    Units: Subjects
        S+ Rubella, Day 42 (N=102;88)
    102
    86
        S+ Rubella, Day 84 (N=102;89)
    101
    89
    No statistical analyses for this end point

    Secondary: Number of subjects with seropositive levels of antibodies against varicella antigens

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    End point title
    		 Number of subjects with seropositive levels of antibodies against varicella antigens [12]
    End point description
    A subject with seropositive levels of antibodies against varicella antigens (S+ Varicella) was defined as a subject with anti-varicella antibody titers ≥4.
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine)
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    100
    89
    Units: Subjects
        S+ Varicella, Day 42 (N=99;87)
    99
    85
        S+ Varicella, Day 84 (N=100;89)
    100
    89
    No statistical analyses for this end point

    Secondary: Number of subjects seroconverted as regards antibodies against measles antigens

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    End point title
    		 Number of subjects seroconverted as regards antibodies against measles antigens [13]
    End point description
    Seroconversion for measles (SCR Measles) was defined as a) appearance of antibody levels ≥the 150 milli-International units per millilitre (mIU/mL) seropositivity assay cut-off in seronegative subjects prior to dose 1 of MMRV vaccine or b) Appearance of antibody levels ≥ the 150 mIU/mL seropositivity assay cut-off in seronegative subjects prior to Dose 1 and 42-56 days after the first dose of MMRV vaccine (prior to Dose 2 of MMRV vaccine). Only the appearance of antibody levels ≥ the 150 mIU/mL seropositivity assay cut-off as assessed at 42-56 days after the second dose of MMRV vaccine, and in seronegative subjects prior to Dose 1 was analysed and tabulated. A seronegative subject as regards antibodies against measles antigens was defined as a subject with anti-measles antibody concentrations < 150 mIU/mL.
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    102
    89
    Units: Subjects
        SCR Measles, Day 42 (N=102;88)
    100
    86
        SCR Measles, Day 84 (N=102;89)
    101
    89
    No statistical analyses for this end point

    Secondary: Number of subjects seroconverted as regards antibodies against mumps antigens

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    End point title
    		 Number of subjects seroconverted as regards antibodies against mumps antigens [14]
    End point description
    Seroconversion for mumps (SCR Mumps) was defined as a) appearance of antibody levels ≥ the 231 units per millilitre (U/mL) seropositivity assay cut-off of in seronegative subjects prior to dose 1 of MMRV vaccine or b) appearance of antibody levels ≥ the 231 U/mL seropositivity assay cut-off in seronegative subjects prior to Dose 1 and 42-56 days after the first dose of MMRV vaccine (prior to Dose 2 of MMRV vaccine). Only the appearance of antibody levels ≥ the 231 U/mL seropositivity assay cut-off as assessed at 42-56 days after the second dose of MMRV vaccine, and in seronegative subjects prior to Dose 1 was analysed and tabulated. A subject with seronegative levels of antibodies against mumps antigens was defined as a subject with anti-mumps antibody concentrations < 231 units per millilitre (U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine)
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    102
    89
    Units: Subjects
        SCR Mumps, Day 42 (N=102;88)
    92
    88
        SCR Mumps, Day 84 (N=102;89)
    99
    89
    No statistical analyses for this end point

    Secondary: Number of subjects seroconverted as regards antibodies against rubella antigens

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    End point title
    		 Number of subjects seroconverted as regards antibodies against rubella antigens [15]
    End point description
    Seroconversion for rubella (SCR Rubella) was defined as a) appearance of antibody levels ≥ the 4 international units per millilitre (IU/mL) seropositivity assay cut-off in seronegative subjects prior to dose 1 of MMRV vaccine or b) appearance of antibody levels ≥ the 4 IU/mL seropositivity assay cut-off in seronegative subjects prior to Dose 1 and 42-56 days after the first dose of MMRV vaccine (prior to Dose 2 of MMRV vaccine). Only the appearance of antibody levels ≥ the 4 IU/mL seropositivity assay cut-off as assessed at 42-56 days after the second dose of MMRV vaccine, and in seronegative subjects prior to Dose 1 was analysed and tabulated. A subject with seronegative levels of antibodies against rubella antigens was defined as a subject with anti-rubella antibody concentrations < 4 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine)
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    102
    89
    Units: Subjects
        SCR Rubella, Day 42 (N=102;88)
    102
    86
        SCR Rubella, Day 84 (N=102;89)
    101
    89
    No statistical analyses for this end point

    Secondary: Number of subjects seroconverted as regards antibodies against varicella antigens

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    End point title
    		 Number of subjects seroconverted as regards antibodies against varicella antigens [16]
    End point description
    Seroconversion for varicella (SCR Varicella) was defined as a) appearance of antibody levels ≥ the seropositivity assay cut-off of 4 (in titers) in seronegative subjects prior to dose 1 of MMRV vaccine or b) appearance of antibody levels ≥ the seropositivity assay cut-off of 4 (in titers) in seronegative subjects prior to Dose 1 and 42-56 days after the first dose of MMRV vaccine (prior to Dose 2 of MMRV vaccine). Only the appearance of antibody levels ≥ the seropositivity assay cut-off of 4 (in titers) as assessed at 42-56 days after the second dose of MMRV vaccine, and in seronegative subjects prior to Dose 1 was analysed and tabulated. A subject with seronegative levels of antibodies against varicella antigens was defined as a subject with anti-varicella antibody titer < 4.
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine)
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    99
    87
    Units: Subjects
        SCR Varicella, Day 42 (N=98;85)
    98
    83
        SCR Varicella, Day 84 (N=99;87)
    99
    87
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against measles antigens

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    End point title
    		 Concentrations of antibodies against measles antigens [17]
    End point description
    The seropositivity cut-off for the assay was an anti-measles antibody (Anti-Measles Ab) concentration ≥ 150 milli-international units per millilitre (mIU/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine).
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    102
    89
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-Measles Ab, Day 42 (N=102;88)
    3740.2 (3181.7 to 4396.8)
    2836.9 (2374 to 3390.1)
        Anti-Measles Ab, Day 84 (N=102;89)
    4792.3 (4071.7 to 5640.5)
    4331.6 (3716.8 to 5048.1)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against mumps antigens

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    End point title
    		 Concentrations of antibodies against mumps antigens [18]
    End point description
    The seropositivity cut-off for the assay was an anti-mumps antibody (Anti-Mumps Ab) concentration ≥ 231 units per millilitre (U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine).
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    102
    89
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-Mumps Ab, Day 42 (N=102;88)
    810.8 (667.3 to 985.1)
    801 (648.5 to 989.4)
        Anti-Mumps Ab, Day 84 (N=102;89)
    1132.7 (968.2 to 1325.2)
    1411.2 (1210.1 to 1645.7)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against rubella antigens

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    End point title
    		 Concentrations of antibodies against rubella antigens [19]
    End point description
    The seropositivity cut-off for the assay was an anti-rubella antibody (Anti-Rubella Ab) concentration ≥4 international units per millilitre (IU/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine).
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    102
    89
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-Rubella Ab, Day 42 (N=102;88)
    39.5 (33.8 to 46.2)
    33 (27 to 40.2)
        Anti-Rubella Ab, Day 84 (N=102;89)
    78.4 (68.3 to 90)
    85.9 (73.8 to 99.9)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against varicella antigens

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    End point title
    		 Concentrations of antibodies against varicella antigens [20]
    End point description
    The seropositivity cut-off for the assay was an anti-varicella antibody (Anti-Varicella Ab) titer ≥ 4
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine)
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    100
    89
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-Varicella Ab, Day 42 (N=99;87)
    124.5 (102.8 to 150.7)
    115.4 (89.2 to 149.3)
        Anti-Varicella Ab, Day 84 (N=100;89)
    1629.3 (1361.9 to 1949.1)
    1583.8 (1290.8 to 1943.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with seropositive levels of antibodies against measles antigens

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    End point title
    		 Number of subjects with seropositive levels of antibodies against measles antigens [21]
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 42 (42-56 days post 1st dose of MMRV vaccine) at Day 84 (42-56 days post 2nd dose of MMRV vaccine)
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analysed in the 10Pn-MMRV and DTPa-HBV-IPV/Hib-MMRV groups.
    End point values
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group
    Number of subjects analysed
    102
    89
    Units: Subjects
        S+ Measles, Day 42 (N=102;88)
    100
    86
        S+ Measles, Day 84 (N=102;89)
    101
    89
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Fever as solicited general symptom (SGS): 15 days post vaccination. Solicited symptoms: 4 days post vaccination. SGSs specific to MMRV & unsolicited AEs: 43 days post vaccination. See below for SAEs timeframes.
    Adverse event reporting additional description
    SAEs: 1) Active Phase: Day 0 to Day 86-112 (2 groups receiving MMRV)/ Day 42-56 (other group); 2) Entire study: Day 0 to Day 222-266 (2 groups receiving MMRV)/Day 180-210 (other group). The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    10Pn-MMRV Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the 2nd dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this107706 study, subjects received at 12 to 14 months of age a booster dose of 10Pn vaccine co-administered with the 1st dose of Priorix-Tetra™ (or MMRV vaccine), and, at 14 to 16 months of age, the 2nd dose of MMRV vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the left thigh or deltoid and the MMRV vaccine subcutaneously in the right deltoid.

    Reporting group title
    DTPa-HBV-IPV/Hib-MMRV Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In the 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the 2nd dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of DTPa-HBV-IPV/Hib vaccine co-administered with the 1st dose of Priorix-Tetra™ (or MMRV vaccine), and, at 14 to 16 months of age, the 2nd dose of MMRV vaccine co-administered with a booster dose of 10Pn vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the left thigh or deltoid and the MMRV vaccine subcutaneously in the right deltoid.

    Reporting group title
    10Pn-DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT (or 10Pn) vaccine during the 10PN-PD-DIT-001 (105553) study (EudraCT number: 2005-003300-11). In the 105553 study, subjects had been primed with 3 doses of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected IM in the left thigh. In this 107706 study, subjects received at 12 to 14 months of age a booster dose of 10Pn vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine. The 10Pn and DTPa-HBV-IPV/Hib vaccines were administered IM in the thigh or deltoid, respectively in the left and right side.

    Serious adverse events
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 110 (4.55%)
    3 / 101 (2.97%)
    4 / 114 (3.51%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Febrile convulsion (Entire Study)
         subjects affected / exposed [1]
    0 / 108 (0.00%)
    1 / 100 (1.00%)
    0 / 111 (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
    Respiratory, thoracic and mediastinal disorders
    Bronchitis chronic (Active Phase)
         subjects affected / exposed
    0 / 110 (0.00%)
    0 / 101 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic (Entire Study)
         subjects affected / exposed [2]
    1 / 108 (0.93%)
    1 / 100 (1.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Adenovirus infection (Active Phase)
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 101 (0.00%)
    0 / 114 (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
    Skin infection (Active Phase)
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 101 (0.00%)
    0 / 114 (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
    Adenovirus infection (Entire Study)
         subjects affected / exposed [3]
    1 / 108 (0.93%)
    0 / 100 (0.00%)
    0 / 111 (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
    Bronchitis (Entire Study)
         subjects affected / exposed [4]
    1 / 108 (0.93%)
    0 / 100 (0.00%)
    0 / 111 (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
    Exanthema subitum (Entire Study)
         subjects affected / exposed [5]
    0 / 108 (0.00%)
    0 / 100 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis (Entire Study)
         subjects affected / exposed [6]
    0 / 108 (0.00%)
    1 / 100 (1.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus (Entire Study)
         subjects affected / exposed [7]
    1 / 108 (0.93%)
    0 / 100 (0.00%)
    0 / 111 (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
    Laryngitis (Entire Study)
         subjects affected / exposed [8]
    0 / 108 (0.00%)
    0 / 100 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin infection (Entire Study)
         subjects affected / exposed [9]
    1 / 108 (0.93%)
    0 / 100 (0.00%)
    0 / 111 (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
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: SAEs for the Entire Study period were only assessed in subjects participating to the ESFU Phase (that is, 108, 100 and 111 subjects in the 10Pn-MMRV, DTPa-HBV-IPV/Hib-MMRV and 10Pn-DTPa-HBV-IPV/Hib Groups, respectively).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: SAEs for the Entire Study period were only assessed in subjects participating to the ESFU Phase (that is, 108, 100 and 111 subjects in the 10Pn-MMRV, DTPa-HBV-IPV/Hib-MMRV and 10Pn-DTPa-HBV-IPV/Hib Groups, respectively).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: SAEs for the Entire Study period were only assessed in subjects participating to the ESFU Phase (that is, 108, 100 and 111 subjects in the 10Pn-MMRV, DTPa-HBV-IPV/Hib-MMRV and 10Pn-DTPa-HBV-IPV/Hib Groups, respectively).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: SAEs for the Entire Study period were only assessed in subjects participating to the ESFU Phase (that is, 108, 100 and 111 subjects in the 10Pn-MMRV, DTPa-HBV-IPV/Hib-MMRV and 10Pn-DTPa-HBV-IPV/Hib Groups, respectively).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: SAEs for the Entire Study period were only assessed in subjects participating to the ESFU Phase (that is, 108, 100 and 111 subjects in the 10Pn-MMRV, DTPa-HBV-IPV/Hib-MMRV and 10Pn-DTPa-HBV-IPV/Hib Groups, respectively).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: SAEs for the Entire Study period were only assessed in subjects participating to the ESFU Phase (that is, 108, 100 and 111 subjects in the 10Pn-MMRV, DTPa-HBV-IPV/Hib-MMRV and 10Pn-DTPa-HBV-IPV/Hib Groups, respectively).
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: SAEs for the Entire Study period were only assessed in subjects participating to the ESFU Phase (that is, 108, 100 and 111 subjects in the 10Pn-MMRV, DTPa-HBV-IPV/Hib-MMRV and 10Pn-DTPa-HBV-IPV/Hib Groups, respectively).
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: SAEs for the Entire Study period were only assessed in subjects participating to the ESFU Phase (that is, 108, 100 and 111 subjects in the 10Pn-MMRV, DTPa-HBV-IPV/Hib-MMRV and 10Pn-DTPa-HBV-IPV/Hib Groups, respectively).
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: SAEs for the Entire Study period were only assessed in subjects participating to the ESFU Phase (that is, 108, 100 and 111 subjects in the 10Pn-MMRV, DTPa-HBV-IPV/Hib-MMRV and 10Pn-DTPa-HBV-IPV/Hib Groups, respectively).
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 10Pn-MMRV Group DTPa-HBV-IPV/Hib-MMRV Group 10Pn-DTPa-HBV-IPV/Hib Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    101 / 110 (91.82%)
    88 / 101 (87.13%)
    84 / 114 (73.68%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    69 / 109 (63.30%)
    50 / 101 (49.50%)
    73 / 112 (65.18%)
         occurrences all number
    69
    50
    73
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    79 / 109 (72.48%)
    75 / 101 (74.26%)
    70 / 112 (62.50%)
         occurrences all number
    79
    75
    70
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    58 / 109 (53.21%)
    57 / 101 (56.44%)
    52 / 112 (46.43%)
         occurrences all number
    58
    57
    52
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    55 / 109 (50.46%)
    54 / 101 (53.47%)
    57 / 112 (50.89%)
         occurrences all number
    55
    54
    57
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    80 / 109 (73.39%)
    73 / 101 (72.28%)
    84 / 112 (75.00%)
         occurrences all number
    80
    73
    84
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    47 / 109 (43.12%)
    33 / 101 (32.67%)
    37 / 112 (33.04%)
         occurrences all number
    47
    33
    37
    Temperature (rectally) > 39.0 °C
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    38 / 109 (34.86%)
    34 / 101 (33.66%)
    9 / 112 (8.04%)
         occurrences all number
    38
    34
    9
    Temperature (rectally) ≥ 38.0°C
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    101 / 109 (92.66%)
    88 / 101 (87.13%)
    69 / 112 (61.61%)
         occurrences all number
    101
    88
    69
    Rash
         subjects affected / exposed [18]
    38 / 109 (34.86%)
    48 / 101 (47.52%)
    18 / 112 (16.07%)
         occurrences all number
    38
    48
    18
    Injection site induration (Unsolicited AE)
         subjects affected / exposed
    5 / 110 (4.55%)
    8 / 101 (7.92%)
    10 / 114 (8.77%)
         occurrences all number
    5
    8
    10
    Irritability (Unsolicited AE)
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 110 (17.27%)
    14 / 101 (13.86%)
    6 / 114 (5.26%)
         occurrences all number
    19
    14
    6
    Eye disorders
    Conjunctivitis (Unsolicited AE)
         subjects affected / exposed
    10 / 110 (9.09%)
    6 / 101 (5.94%)
    6 / 114 (5.26%)
         occurrences all number
    10
    6
    6
    Gastrointestinal disorders
    Diarrhoea (Unsolicited AE)
         subjects affected / exposed
    17 / 110 (15.45%)
    15 / 101 (14.85%)
    9 / 114 (7.89%)
         occurrences all number
    17
    15
    9
    Teething (Unsolicited AE)
         subjects affected / exposed
    14 / 110 (12.73%)
    14 / 101 (13.86%)
    5 / 114 (4.39%)
         occurrences all number
    14
    14
    5
    Vomiting (Unsolicited AE)
         subjects affected / exposed
    7 / 110 (6.36%)
    8 / 101 (7.92%)
    3 / 114 (2.63%)
         occurrences all number
    7
    8
    3
    Respiratory, thoracic and mediastinal disorders
    Cough (Unsolicited AE)
         subjects affected / exposed
    15 / 110 (13.64%)
    27 / 101 (26.73%)
    7 / 114 (6.14%)
         occurrences all number
    15
    27
    7
    Infections and infestations
    Bronchitis (Unsolicited AE)
         subjects affected / exposed
    4 / 110 (3.64%)
    5 / 101 (4.95%)
    5 / 114 (4.39%)
         occurrences all number
    4
    5
    5
    Gastroenteritis (Unsolicited AE)
         subjects affected / exposed
    6 / 110 (5.45%)
    5 / 101 (4.95%)
    8 / 114 (7.02%)
         occurrences all number
    6
    5
    8
    Otitis media (Unsolicited AE)
         subjects affected / exposed
    26 / 110 (23.64%)
    28 / 101 (27.72%)
    18 / 114 (15.79%)
         occurrences all number
    26
    28
    18
    Respiratory tract infection (Unsolicited AE)
         subjects affected / exposed
    5 / 110 (4.55%)
    5 / 101 (4.95%)
    3 / 114 (2.63%)
         occurrences all number
    5
    5
    3
    Rhinitis (Unsolicited AE)
         subjects affected / exposed
    19 / 110 (17.27%)
    30 / 101 (29.70%)
    13 / 114 (11.40%)
         occurrences all number
    19
    30
    13
    Upper respiratory tract infection (Unsolicited AE)
         subjects affected / exposed
    27 / 110 (24.55%)
    21 / 101 (20.79%)
    18 / 114 (15.79%)
         occurrences all number
    27
    21
    18
    Metabolism and nutrition disorders
    Anorexia (Unsolicited AE)
         subjects affected / exposed
    8 / 110 (7.27%)
    2 / 101 (1.98%)
    1 / 114 (0.88%)
         occurrences all number
    8
    2
    1
    Notes
    [10] - 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: Assessment of solicited local and general symptoms was done in subjects with available results for the symptom specified.
    [11] - 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: Assessment of solicited local and general symptoms was done in subjects with available results for the symptom specified.
    [12] - 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: Assessment of solicited local and general symptoms was done in subjects with available results for the symptom specified.
    [13] - 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: Assessment of solicited local and general symptoms was done in subjects with available results for the symptom specified.
    [14] - 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: Assessment of solicited local and general symptoms was done in subjects with available results for the symptom specified.
    [15] - 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: Assessment of solicited local and general symptoms was done in subjects with available results for the symptom specified.
    [16] - 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: Assessment of solicited local and general symptoms was done in subjects with available results for the symptom specified.
    [17] - 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: Assessment of solicited local and general symptoms was done in subjects with available results for the symptom specified.
    [18] - 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: Assessment of solicited local and general symptoms was done in subjects with available results for the symptom specified.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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