Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase IIIb multi-centre, open, controlled study to assess the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b – meningococcal serogroup C conjugate (Hib-MenC) vaccine (Menitorix) in preterm and full-term infants when co-administered with GSK Biologicals’ DTPa-HBV-IPV vaccine (Infanrix penta) and with Wyeth’s 7-valent pneumococcal conjugate vaccine (Prevenar) and given according to a 2, 4 and 6 months of age primary vaccination schedule and when given as a booster dose with concomitant GSK Biologicals’ DTPa-IPV vaccine (Infanrix IPV) and Wyeth’s Prevenar in the second year of life. Estudio fase IIIb abierto, multicéntrico, controlado, para evaluar la inmunogenicidad, reactogenicidad y seguridad de la vacuna conjugada frente a Haemophilus Influenzae tipo b y Meningococo del serogrupo C (Hib-MenC) (Menitorix) de GSK Biologicals en niños prematuros y nacidos a término cuando se administra simultáneamente con la vacuna DTPa-HBV-IPV de GSK Biologicals (Infanrix penta) y con la vacuna conjugada antineumocócica 7-valente de Wyeth (Prevenar) administrada como pauta primaria de vacunación a los 2, 4 y 6 meses de edad y cuando se administra como dosis de recuerdo simultáneamente con la vacuna DTPa-IPV de GSK Biologicals (Infanrix IPV) y Prevenar en el segundo año de vida.

    Summary
    EudraCT number
    		 2007-001167-29
    Trial protocol
    		 ES  
    Global end of trial date
    30 Dec 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Jun 2022
    First version publication date
    23 Jan 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    110215, 110217
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00586612
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'institut 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 32 2 656 81 11, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 32 2 656 81 11, 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
    10 Apr 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary vaccination At one month after the third dose (Post dose 3) in preterm and full-term infants: •To evaluate the immunogenicity of GSK Biologicals’ Hib-MenC vaccine when given concomitantly with GSK Biologicals’ DTPa-HBV-IPV vaccine and Wyeth’s 7-valent pneumococcal vaccine, in terms of percentage of subjects with: - Anti-PRP concentration >=0.15 microg/ml - rSBA-MenC titre >=1:8
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2007
    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
    Spain: 313
    Worldwide total number of subjects
    313
    EEA total number of subjects
    313
    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)
    313
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Primary phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Preterm group
    Arm description
    		 Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

    Investigational medicinal product name
    Infanrix penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

    Investigational medicinal product name
    Infanrix IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 1 dose in the Booster study.

    Arm title
    		 Full-term group
    Arm description
    		 Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

    Investigational medicinal product name
    Infanrix penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

    Investigational medicinal product name
    Infanrix IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 1 dose in the Booster study.

    Number of subjects in period 1
    		Preterm group Full-term group
    Started
    163
    150
    Completed
    162
    147
    Not completed
    1
    3
         Consent withdrawn by subject
    -
    2
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    -
    Period 2
    Period 2 title
    Booster phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Preterm group
    Arm description
    		 Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

    Investigational medicinal product name
    Infanrix penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

    Investigational medicinal product name
    Infanrix IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 1 dose in the Booster study.

    Arm title
    		 Full-term group
    Arm description
    		 Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

    Investigational medicinal product name
    Infanrix penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

    Investigational medicinal product name
    Infanrix IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 1 dose in the Booster study.

    Number of subjects in period 2 [1]
    		Preterm group Full-term group
    Started
    154
    144
    Completed
    151
    143
    Not completed
    3
    1
         Lost to follow-up
    3
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all the subjects enrolled in the Primary phase started the Booster phase.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Preterm group
    Reporting group description
    		 Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.

    Reporting group title
    Full-term group
    Reporting group description
    		 Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.

    Reporting group values
    		 Preterm group Full-term group Total
    Number of subjects
    		 163 150 313
    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: weeks
        geometric mean (standard deviation)
    		 8.9 ( 1.15 ) 8.8 ( 0.79 ) -
    Gender categorical
    Units: Subjects
        Female
    		 77 65 142
        Male
    		 86 85 171

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Preterm group
    Reporting group description
    		 Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.

    Reporting group title
    Full-term group
    Reporting group description
    		 Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.
    Reporting group title
    Preterm group
    Reporting group description
    		 Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.

    Reporting group title
    Full-term group
    Reporting group description
    		 Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.

    Primary: Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 0.15 micrograms per milliliter (µg/mL)

    		 Close Top of page
    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 0.15 micrograms per milliliter (µg/mL) [1]
    End point description
    Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.
    End point type
    Primary
    End point timeframe
    One month after the third vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    140
    142
    Units: Subjects
        (anti-PRP)
    139
    141
    No statistical analyses for this end point

    Primary: Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to 1:8

    		 Close Top of page
    End point title
    		 Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to 1:8 [2]
    End point description
    rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.
    End point type
    Primary
    End point timeframe
    One month after the third 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: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    143
    140
    Units: Subjects
        (rSBA-MenC)
    142
    140
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-Polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with Anti-Polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to the cut-off values
    End point description
    Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.
    End point type
    Secondary
    End point timeframe
    Before vaccination (at Day 0)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    140
    138
    Units: Subjects
        ≥ 0.15 µg/mL
    38
    43
        ≥ 1.0 µg/mL
    5
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 1 microgram per milliliter

    		 Close Top of page
    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 1 microgram per milliliter
    End point description
    Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    One month after the third vaccination
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    140
    142
    Units: Subjects
        (anti-PRP)
    133
    134
    No statistical analyses for this end point

    Secondary: Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to the cut-off values
    End point description
    rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.
    End point type
    Secondary
    End point timeframe
    Before vaccination (at Day 0)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    141
    137
    Units: Subjects
        ≥ 1:8
    16
    23
        ≥ 1:32
    5
    11
        ≥ 1:128
    0
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to the cut-off values
    End point description
    rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.
    End point type
    Secondary
    End point timeframe
    One month after the third vaccination
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    143
    140
    Units: Subjects
        ≥ 1:32
    142
    139
        ≥ 1:128
    135
    136
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-polysaccharide C (anti-PSC) antibody concentration greater than or equal to (≥) the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with Anti-polysaccharide C (anti-PSC) antibody concentration greater than or equal to (≥) the cut-off values
    End point description
    Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.
    End point type
    Secondary
    End point timeframe
    Before vaccination (at Day 0)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    142
    137
    Units: Subjects
        ≥ 0.3 µg/mL
    23
    36
        ≥ 2.0 µg/mL
    3
    8
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-polysaccharide C (anti-PSC) antibody concentration greater than or equal to (≥) the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with Anti-polysaccharide C (anti-PSC) antibody concentration greater than or equal to (≥) the cut-off values
    End point description
    Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.
    End point type
    Secondary
    End point timeframe
    One month after the third dose
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    140
    141
    Units: Subjects
        ≥ 0.3 µg/mL
    140
    141
        ≥ 2.0 µg/mL
    127
    136
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentration greater than or equal to (≥) the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentration greater than or equal to (≥) the cut-off values
    End point description
    Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before vaccination (at Day 0)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    112
    118
    Units: Subjects
        ≥ 10 mIU/mL
    89
    78
        ≥ 100 mIU/mL
    3
    8
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentration greater than or equal to (≥) the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentration greater than or equal to (≥) the cut-off values
    End point description
    Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.
    End point type
    Secondary
    End point timeframe
    One month after the third dose
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    129
    129
    Units: Subjects
        ≥ 10 mIU/mL
    128
    129
        ≥ 100 mIU/mL
    109
    117
    No statistical analyses for this end point

    Secondary: Anti-polyribosylribitol phosphate (anti-PRP) and anti-polysaccharide C (anti-PSC) concentration

    		 Close Top of page
    End point title
    		 Anti-polyribosylribitol phosphate (anti-PRP) and anti-polysaccharide C (anti-PSC) concentration
    End point description
    Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    Before vaccination (at Day 0)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    142
    138
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP (n=140, 138)
    0.116 (0.101 to 0.133)
    0.14 (0.117 to 0.167)
        Anti-PSC (n=142, 137)
    0.19 (0.17 to 0.22)
    0.25 (0.21 to 0.3)
    No statistical analyses for this end point

    Secondary: Anti-polyribosylribitol phosphate (anti-PRP) and anti-polysaccharide C (anti-PSC) concentration

    		 Close Top of page
    End point title
    		 Anti-polyribosylribitol phosphate (anti-PRP) and anti-polysaccharide C (anti-PSC) concentration
    End point description
    Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    One month after the third dose
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    140
    142
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP (n= 140, 142)
    10.437 (8.398 to 12.97)
    10.473 (8.547 to 12.833)
        Anti-PSC (n= 140, 141)
    6.34 (5.57 to 7.22)
    7.46 (6.67 to 8.34)
    No statistical analyses for this end point

    Secondary: Anti-hepatitis B surface antigen (anti-HBs) concentration

    		 Close Top of page
    End point title
    		 Anti-hepatitis B surface antigen (anti-HBs) concentration
    End point description
    Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    Before vaccination (at Day 0)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    112
    118
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-hepatitis B surface antigen (anti-HBs)
    24.79 (19.82 to 31)
    16.67 (13.52 to 20.56)
    No statistical analyses for this end point

    Secondary: Anti-hepatitis B surface antigen (anti-HBs) concentration

    		 Close Top of page
    End point title
    		 Anti-hepatitis B surface antigen (anti-HBs) concentration
    End point description
    Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    One month after the third dose
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    129
    129
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-hepatitis B surface antigen (anti-HBs)
    372.3 (299.98 to 462.04)
    586.58 (473.8 to 726.21)
    No statistical analyses for this end point

    Secondary: Meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer

    		 Close Top of page
    End point title
    		 Meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer
    End point description
    rSBA-MenC titers are given as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    Before vaccination (at Day 0)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    141
    137
    Units: Titer
    geometric mean (confidence interval 95%)
        (rSBA-MenC)
    4.9 (4.5 to 5.5)
    5.9 (4.9 to 6.9)
    No statistical analyses for this end point

    Secondary: Meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer

    		 Close Top of page
    End point title
    		 Meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer
    End point description
    rSBA-MenC titers are given as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    One month after the third dose
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    143
    140
    Units: titre
    geometric mean (confidence interval 95%)
        (rSBA-MenC)
    1055.9 (859.1 to 1297.7)
    1346.2 (1130.4 to 1603.1)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local symptoms

    		 Close Top of page
    End point title
    		 Number of subjects reporting solicited local symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period after any primary vaccination dose
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    163
    150
    Units: Subjects
        Pain
    106
    100
        Redness
    94
    123
        Swelling
    91
    113
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general symptoms

    		 Close Top of page
    End point title
    		 Number of subjects reporting solicited general symptoms
    End point description
    Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period after any primary vaccination dose
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    163
    150
    Units: Subjects
        Drowsiness
    111
    102
        Fever
    89
    85
        Irritability/fussiness
    128
    105
        Loss of appetite
    99
    100
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects reporting unsolicited adverse events (AEs)
    End point description
    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    Within 31 days after each primary vaccination
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    163
    150
    Units: Subjects
        (AEs)
    56
    72
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAEs)

    		 Close Top of page
    End point title
    		 Number of subjects reporting serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    Throughout the entire primary vaccination phase
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    163
    150
    Units: Subjects
        (SAEs)
    11
    8
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 0.15 microgram per milliliter (µg/mL)

    		 Close Top of page
    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 0.15 microgram per milliliter (µg/mL)
    End point description
    Anti-PRP antibody cut-off value assessed was 0.15 microgram per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Month 14) and one month after the booster vaccination (Month 15)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    133
    134
    Units: Subjects
        Pre-booster (n= 133; 130)
    116
    117
        Post-booster (n= 132; 134)
    132
    134
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 1.0 microgram per milliliter (µg/mL)

    		 Close Top of page
    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 1.0 microgram per milliliter (µg/mL)
    End point description
    Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Month 14) and one month after the booster vaccination (Month 15)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    133
    134
    Units: Subjects
        Pre-booster (n= 133; 130)
    53
    53
        Post-booster (n= 132; 134)
    132
    134
    No statistical analyses for this end point

    Secondary: Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to the cut-off values
    End point description
    rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.
    End point type
    Secondary
    End point timeframe
    Prior to (Month 14) and one month after the booster vaccination (Month 15)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    134
    137
    Units: Subjects
        ≥ 1:8 pre-booster (n= 134; 134)
    102
    117
        ≥ 1:8 post-booster (n= 133; 137)
    132
    136
        ≥ 1:32 pre-booster (n= 134; 134)
    95
    115
        ≥ 1:32 post-booster (n= 133; 137)
    132
    136
        ≥ 1:128 pre-booster (n= 134; 134)
    69
    85
        ≥ 1:128 post-booster (n= 133; 137)
    131
    136
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polysaccharide C (anti-PSC) antibody concentration greater than or equal to the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with anti-polysaccharide C (anti-PSC) antibody concentration greater than or equal to the cut-off values
    End point description
    Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.
    End point type
    Secondary
    End point timeframe
    Prior to (Month 14) and one month after the booster vaccination (Month 15)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    130
    129
    Units: Subjects
        ≥ 0.3 µg/mL pre-booster (n= 130; 127)
    74
    92
        ≥ 0.3 µg/mL post-booster (n= 117; 129)
    116
    129
        ≥ 2.0 µg/mL pre-booster (n= 130; 127)
    11
    11
        ≥ 2.0 µg/mL post-booster (n= 117; 129)
    105
    124
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentration greater than or equal to the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentration greater than or equal to the cut-off values
    End point description
    Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL. Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component.
    End point type
    Secondary
    End point timeframe
    Prior to (Month 14) the booster vaccination
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    125
    116
    Units: Subjects
        ≥ 10 mIU/mL pre-booster
    121
    113
        ≥ 100 mIU/mL pre-booster
    61
    71
    No statistical analyses for this end point

    Secondary: Anti-polyribosylribitol phosphate (anti-PRP) and anti-polysaccharide C (anti-PSC) concentration

    		 Close Top of page
    End point title
    		 Anti-polyribosylribitol phosphate (anti-PRP) and anti-polysaccharide C (anti-PSC) concentration
    End point description
    Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Month 14) and one month after the booster vaccination (Month 15)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    133
    134
    Units: µg/mL
    geometric mean (confidence interval 95%)
        anti-PRP pre-booster (n= 133; 130)
    0.706 (0.565 to 0.881)
    0.777 (0.622 to 0.972)
        anti-PRP post-booster (n= 132; 134)
    50.343 (41.627 to 60.884)
    54.625 (45.325 to 65.834)
        anti-PSC pre-booster (n= 130; 127)
    0.42 (0.35 to 0.51)
    0.56 (0.47 to 0.67)
        anti-PSC post-booster (n= 117; 129)
    10.06 (8.14 to 12.45)
    11.31 (9.6 to 13.31)
    No statistical analyses for this end point

    Secondary: Anti-hepatitis B surface antigen (anti-HBs) concentration

    		 Close Top of page
    End point title
    		 Anti-hepatitis B surface antigen (anti-HBs) concentration
    End point description
    Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL). Note: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component.
    End point type
    Secondary
    End point timeframe
    Prior to (Month 14) the booster vaccination
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    125
    116
    Units: :mIU/mL
    geometric mean (confidence interval 95%)
        (anti-HBs)
    95.9 (75.6 to 121.5)
    145.6 (112.1 to 189.1)
    No statistical analyses for this end point

    Secondary: Meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer

    		 Close Top of page
    End point title
    		 Meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer
    End point description
    rSBA-MenC titers are given as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    Prior to (Month 14) and one month after the booster vaccination (Month 15)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    134
    137
    Units: titre
    geometric mean (confidence interval 95%)
        Pre-booster (n= 134; 134)
    79.3 (56.3 to 111.8)
    147.8 (110.9 to 197.1)
        Post-booster (n= 133; 137)
    4883.1 (3783.1 to 6302.9)
    5288.8 (4244.9 to 6589.4)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited symptoms (local and general)

    		 Close Top of page
    End point title
    		 Number of subjects reporting solicited symptoms (local and general)
    End point description
    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period following booster vaccination
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    154
    144
    Units: Subjects
        Pain
    82
    98
        Redness
    77
    109
        Swelling
    67
    94
        Drowsiness
    33
    46
        Fever
    43
    53
        Irritability
    70
    69
        Loss of appetite
    34
    50
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects reporting unsolicited adverse events (AEs)
    End point description
    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    Within 31 days after the booster vaccination (month 15)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    154
    144
    Units: Subjects
        (AEs)
    34
    42
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAEs)

    		 Close Top of page
    End point title
    		 Number of subjects reporting serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Period 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14). Period 2 is defined as the administration of the booster dose until the end of the study (Month 15).
    End point type
    Secondary
    End point timeframe
    31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)
    End point values
    		 Preterm group Full-term group
    Number of subjects analysed
    154
    144
    Units: Subjects
        Period 1
    10
    2
        Period 2
    1
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination.
    Adverse event reporting additional description
    Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Preterm group
    Reporting group description
    		 Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.

    Reporting group title
    Full-term group
    Reporting group description
    		 Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix, Infanrix penta and Prevenar and a booster dose of Menitorix, Infanrix IPV and Prevenar at 16-18 months of age.

    Serious adverse events
    		 Preterm group Full-term group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 163 (13.50%)
    10 / 150 (6.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    4 / 163 (2.45%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    6 / 163 (3.68%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 163 (2.45%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candidiasis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningococcal sepsis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Preterm group Full-term group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    153 / 163 (93.87%)
    144 / 150 (96.00%)
    General disorders and administration site conditions
    Injection site nodule
         subjects affected / exposed
    3 / 163 (1.84%)
    24 / 150 (16.00%)
         occurrences all number
    3
    24
    Pain (After primary vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    106 / 163 (65.03%)
    100 / 150 (66.67%)
         occurrences all number
    106
    100
    Redness (After primary vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    94 / 163 (57.67%)
    123 / 150 (82.00%)
         occurrences all number
    94
    123
    Swelling (After primary vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    91 / 163 (55.83%)
    113 / 150 (75.33%)
         occurrences all number
    91
    123
    Drowsiness (After primary vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    111 / 163 (68.10%)
    102 / 150 (68.00%)
         occurrences all number
    111
    102
    Fever (After primary vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    89 / 163 (54.60%)
    85 / 150 (56.67%)
         occurrences all number
    89
    85
    Irritability/fussiness (After primary vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    128 / 163 (78.53%)
    105 / 150 (70.00%)
         occurrences all number
    128
    105
    Loss of appetite (After primary vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    99 / 163 (60.74%)
    100 / 150 (66.67%)
         occurrences all number
    99
    100
    Pain (After booster vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    82 / 154 (53.25%)
    98 / 144 (68.06%)
         occurrences all number
    82
    98
    Redness (After booster vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    77 / 154 (50.00%)
    109 / 144 (75.69%)
         occurrences all number
    77
    109
    Swelling (After booster vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    67 / 154 (43.51%)
    94 / 144 (65.28%)
         occurrences all number
    67
    94
    Drowsiness (After booster vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    33 / 154 (21.43%)
    46 / 144 (31.94%)
         occurrences all number
    33
    46
    Fever (After booster vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    43 / 154 (27.92%)
    53 / 144 (36.81%)
         occurrences all number
    43
    53
    Irritability/fussiness (After booster vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    70 / 154 (45.45%)
    69 / 144 (47.92%)
         occurrences all number
    70
    69
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    9 / 163 (5.52%)
    6 / 150 (4.00%)
         occurrences all number
    9
    6
    Infections and infestations
    Injection site haematoma
         subjects affected / exposed
    1 / 163 (0.61%)
    9 / 150 (6.00%)
         occurrences all number
    1
    9
    Loss of appetite (After booster vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    34 / 154 (22.08%)
    50 / 144 (34.72%)
         occurrences all number
    34
    69
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 163 (4.29%)
    11 / 150 (7.33%)
         occurrences all number
    7
    11
    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 analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [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 analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [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 analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [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 analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [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 analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [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 analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [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 analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu Apr 25 03:30:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA