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   43851   clinical trials with a EudraCT protocol, of which   7283   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:
    Phase III, non-randomised, open-label study to evaluate the safety and immunogenicity of a prime-boost schedule of the H1N1 candidate vaccine adjuvanted with AS03B administered to subjects aged 3 to 17 years.

    Summary
    EudraCT number
    		 2009-015011-41
    Trial protocol
    		 DE  
    Global end of trial date
    22 Nov 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Mar 2021
    First version publication date
    31 May 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections in safety section.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    113638
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00972517
    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 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000725-PIP01-09
    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
    22 Nov 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Nov 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Nov 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the humoral immune response after two primary administrations of the candidate H1N1 pandemic vaccine that meets or exceeds the EMEA (CHMP) guidance targets for pandemic vaccine seroconversion rate (SCR), seroprotection rate (SPR) and geometric mean fold rise (GMFR) at 21 days after the second dose of H1N1 vaccine in children aged 3 to 17 years. To evaluate the superiority in terms of vaccine virus homologous haemagglutination inhibition (HI) antibody response of a single dose of the H1N1 candidate vaccine administered as a 6-month booster after 2-dose primary vaccination compared to the response after the first dose of primary vaccination.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of anaphylaxis following the administration of vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 245
    Worldwide total number of subjects
    245
    EEA total number of subjects
    245
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    123
    Adolescents (12-17 years)
    122
    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
    		 One subject was enrolled but not vaccinated and therefore, was not included in the number of subjects under "started".

    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
    At Day 21 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Flu BS1_3-5 Years Group
    Arm description
    		 Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination);
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pandemrix
    Investigational medicinal product code
    GSK2340272A
    Other name
    GlaxoSmithKline (GSK) Biologicals’ A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the Flu vaccine at Day 0 and 21, administered in the deltoid region of the non-dominant arm.

    Arm title
    		 Flu BS1_6-9 Years Group
    Arm description
    		 Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination);
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pandemrix
    Investigational medicinal product code
    GSK2340272A
    Other name
    GlaxoSmithKline (GSK) Biologicals’ A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the Flu vaccine at Day 0 and 21, administered in the deltoid region of the non-dominant arm

    Arm title
    		 Flu BS1_10-17 Years Group
    Arm description
    		 Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination);
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pandemrix
    Investigational medicinal product code
    GSK2340272A
    Other name
    GlaxoSmithKline (GSK) Biologicals’ A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the Flu vaccine at Day 0 and 21, administered in the deltoid region of the non-dominant arm.

    Arm title
    		 Flu BS2_3-5 Years Group
    Arm description
    		 Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pandemrix
    Investigational medicinal product code
    GSK2340272A
    Other name
    GlaxoSmithKline (GSK) Biologicals’ A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the Flu vaccine at Day 0 and 21, administered in the deltoid region of the non-dominant arm.

    Arm title
    		 Flu BS2_6-9 Years Group
    Arm description
    		 Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pandemrix
    Investigational medicinal product code
    GSK2340272A
    Other name
    GlaxoSmithKline (GSK) Biologicals’ A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the Flu vaccine at Day 0 and 21, administered in the deltoid region of the non-dominant arm.

    Arm title
    		 Flu BS2_10-17 Years Group
    Arm description
    		 Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pandemrix
    Investigational medicinal product code
    GSK2340272A
    Other name
    GlaxoSmithKline (GSK) Biologicals’ A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the Flu vaccine at Day 0 and 21, administered in the deltoid region of the non-dominant arm.

    Arm title
    		 Flu pooled_3-5 Years Group
    Arm description
    		 Pooled data of subjects aged 3 to 5 years from the Flu BS1 and Flu BS2 Groups
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pandemrix
    Investigational medicinal product code
    GSK2340272A
    Other name
    GlaxoSmithKline (GSK) Biologicals’ A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the Flu vaccine at Day 0 and 21, administered in the deltoid region of the non-dominant arm.

    Arm title
    		 Flu pooled_6-9 Years Group
    Arm description
    		 Pooled data of subjects aged 6 to 9 years from the Flu BS1 and Flu BS2 Groups
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pandemrix
    Investigational medicinal product code
    GSK2340272A
    Other name
    GlaxoSmithKline (GSK) Biologicals’ A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the Flu vaccine at Day 0 and 21, administered in the deltoid region of the non-dominant arm.

    Arm title
    		 Flu pooled_10-17 Years Group
    Arm description
    		 Pooled data of subjects aged 10 to 17 years from the Flu BS1 and Flu BS2 Groups
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pandemrix
    Investigational medicinal product code
    GSK2340272A
    Other name
    GlaxoSmithKline (GSK) Biologicals’ A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the Flu vaccine at Day 0 and 21, administered in the deltoid region of the non-dominant arm.

    Number of subjects in period 1
    		Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group Flu pooled_3-5 Years Group Flu pooled_6-9 Years Group Flu pooled_10-17 Years Group
    Started
    31
    31
    60
    30
    34
    58
    61
    65
    118
    Completed
    31
    30
    60
    27
    33
    58
    58
    63
    118
    Not completed
    0
    1
    0
    3
    1
    0
    3
    2
    0
         Consent withdrawn by subject
    -
    1
    -
    2
    1
    -
    2
    2
    -
         Adverse event, non-fatal
    -
    -
    -
    1
    -
    -
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups [1]
    Reporting group title
    At Day 21
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of the 245 subjects enrolled in this trial, 1 subject did not receive vaccination even though the subject number had been allocated; hence he/she was excluded from the study start.
    Reporting group values
    		 At Day 21 Total
    Number of subjects
    		 244 244
    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: years
        geometric mean (standard deviation)
    		 9.2 ± 4.15 -
    Gender categorical
    Units: Subjects
        Female
    		 116 116
        Male
    		 128 128

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Flu BS1_3-5 Years Group
    Reporting group description
    		 Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination);

    Reporting group title
    Flu BS1_6-9 Years Group
    Reporting group description
    		 Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination);

    Reporting group title
    Flu BS1_10-17 Years Group
    Reporting group description
    		 Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination);

    Reporting group title
    Flu BS2_3-5 Years Group
    Reporting group description
    		 Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).

    Reporting group title
    Flu BS2_6-9 Years Group
    Reporting group description
    		 Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).

    Reporting group title
    Flu BS2_10-17 Years Group
    Reporting group description
    		 Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).

    Reporting group title
    Flu pooled_3-5 Years Group
    Reporting group description
    		 Pooled data of subjects aged 3 to 5 years from the Flu BS1 and Flu BS2 Groups

    Reporting group title
    Flu pooled_6-9 Years Group
    Reporting group description
    		 Pooled data of subjects aged 6 to 9 years from the Flu BS1 and Flu BS2 Groups

    Reporting group title
    Flu pooled_10-17 Years Group
    Reporting group description
    		 Pooled data of subjects aged 10 to 17 years from the Flu BS1 and Flu BS2 Groups

    Primary: Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against the Flu A/California/7/2009 (H1N1) vaccine strain

    		 Close Top of page
    End point title
    		 Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against the Flu A/California/7/2009 (H1N1) vaccine strain [1] [2]
    End point description
    Antibody titers were expressed as Geometric mean titers (GMTs).
    End point type
    Primary
    End point timeframe
    At Day 0, Day 21 and Day 42
    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: This outcome was descriptive; hence no statistical analyses were required.
    [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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Number of subjects analysed
    28
    30
    54
    25 [3]
    30 [4]
    57 [5]
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1, Day 0
    5.7 (4.5 to 7.2)
    5.2 (4.8 to 5.8)
    9.9 (7 to 14.1)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        H1N1, Day 21
    192.6 (145.6 to 254.8)
    190.3 (147 to 246.3)
    479.3 (361.8 to 634.9)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        H1N1, Day 42
    1361.7 (1107 to 1674.9)
    970.1 (765.8 to 1228.8)
    1069.4 (892.6 to 1281.3)
    1161.7 (905.2 to 1490.9)
    915.7 (759.1 to 1104.6)
    979.6 (845.3 to 1135.2)
    Notes
    [3] - This outcome measure was assessed only at Day 42 for the Flu BS2_3-5 Years Group.
    [4] - This outcome measure was assessed only at Day 42 for the Flu BS2_6-9 Years Group.
    [5] - This outcome measure was assessed only at Day 42 for the Flu BS2_10-17 Years Group.
    No statistical analyses for this end point

    Primary: Number of seroconverted subjects for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain

    		 Close Top of page
    End point title
    		 Number of seroconverted subjects for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain [6] [7]
    End point description
    A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This outcome was descriptive; hence no statistical analyses were required.
    [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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
    Number of subjects analysed
    28
    30
    54
    Units: Subjects
        H1N1
    28
    30
    53
    No statistical analyses for this end point

    Primary: Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain

    		 Close Top of page
    End point title
    		 Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain [8] [9]
    End point description
    A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This outcome was descriptive; hence no statistical analyses were required.
    [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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
    Number of subjects analysed
    28
    30
    54
    Units: Subjects
        H1N1
    28
    30
    54
    No statistical analyses for this end point

    Primary: HI antibody geometric mean fold rise (GMFR) against the Flu A/California/7/2009 (H1N1) virus strain

    		 Close Top of page
    End point title
    		 HI antibody geometric mean fold rise (GMFR) against the Flu A/California/7/2009 (H1N1) virus strain [10] [11]
    End point description
    GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This outcome was descriptive; hence no statistical analyses were required.
    [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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
    Number of subjects analysed
    28
    30
    54
    Units: Fold increase
    geometric mean (confidence interval 95%)
        H1N1
    237.68 (175.28 to 322.29)
    185.25 (142.09 to 241.52)
    107.74 (76.64 to 151.45)
    No statistical analyses for this end point

    Secondary: Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against the Flu A/California/7/2009 (H1N1) vaccine strain

    		 Close Top of page
    End point title
    		 Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against the Flu A/California/7/2009 (H1N1) vaccine strain [12]
    End point description
    Antibody titers were expressed as geometric mean titers (GMTs)
    End point type
    Secondary
    End point timeframe
    At Month 6
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Number of subjects analysed
    27
    28
    53
    23
    27
    47
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1
    140.8 (118.2 to 167.6)
    154.2 (126.5 to 187.9)
    254.6 (199 to 325.7)
    129.4 (94.6 to 176.9)
    148.2 (119 to 184.4)
    243.6 (185.9 to 319.3)
    No statistical analyses for this end point

    Secondary: Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against the Flu A/California/7/2009 (H1N1) vaccine strain

    		 Close Top of page
    End point title
    		 Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against the Flu A/California/7/2009 (H1N1) vaccine strain [13]
    End point description
    Antibody titers were expressed as geometric mean titers (GMTs)
    End point type
    Secondary
    End point timeframe
    At Month 12
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Number of subjects analysed
    20
    26
    41
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1
    48.5 (35.7 to 65.7)
    60.5 (49.2 to 74.3)
    132.8 (94.9 to 185.8)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain

    		 Close Top of page
    End point title
    		 Number of seroconverted subjects for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain [14]
    End point description
    A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
    End point type
    Secondary
    End point timeframe
    At Month 6
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
    Number of subjects analysed
    27
    28
    53
    Units: Subjects
        H1N1
    27
    28
    50
    No statistical analyses for this end point

    Secondary: Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain

    		 Close Top of page
    End point title
    		 Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain [15]
    End point description
    A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
    End point type
    Secondary
    End point timeframe
    At Month 6
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Number of subjects analysed
    27
    28
    53
    23
    27
    47
    Units: Subjects
        H1N1
    27
    28
    53
    20
    27
    47
    No statistical analyses for this end point

    Secondary: Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain

    		 Close Top of page
    End point title
    		 Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain [16]
    End point description
    A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
    End point type
    Secondary
    End point timeframe
    At Month 12
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Number of subjects analysed
    20
    26
    41
    Units: Subjects
        H1N1
    17
    22
    37
    No statistical analyses for this end point

    Secondary: HI antibody geometric mean fold rise (GMFR) against the Flu A/California/7/2009 (H1N1) virus strain

    		 Close Top of page
    End point title
    		 HI antibody geometric mean fold rise (GMFR) against the Flu A/California/7/2009 (H1N1) virus strain [17]
    End point description
    GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
    End point type
    Secondary
    End point timeframe
    At Month 6
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
    Number of subjects analysed
    27
    28
    53
    Units: Fold increase
    geometric mean (confidence interval 95%)
        H1N1
    27.44 (22.42 to 33.57)
    29.35 (23.53 to 36.61)
    25.32 (18.6 to 34.47)
    No statistical analyses for this end point

    Secondary: Humoral immune response in terms of neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) vaccine strain

    		 Close Top of page
    End point title
    		 Humoral immune response in terms of neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) vaccine strain [18]
    End point description
    Antibody titers were expressed as Geometric mean titers (GMTs). This analysis was conducted on a subset of one third of the subjects who were randomly selected.
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21, Day 42 and Month 6
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Number of subjects analysed
    16
    15
    14
    12 [19]
    13
    15 [20]
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1, Day 0
    4.9 (3.9 to 6.1)
    7.1 (3.9 to 12.7)
    8 (3 to 21.3)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        H1N1, Day 21
    27.7 (13 to 58.8)
    65.9 (24.6 to 176.4)
    109.4 (34.5 to 346.7)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        H1N1, Day 42
    433.2 (295.2 to 635.6)
    473.7 (301.5 to 744.1)
    438.4 (191.3 to 1004.8)
    533.4 (298.4 to 953.7)
    260.1 (141.9 to 476.6)
    199.5 (112.7 to 353.2)
        H1N1, Month 6
    158.9 (110.4 to 228.8)
    203.3 (133.7 to 309.3)
    232.1 (81.8 to 658.4)
    156.6 (89.8 to 273.3)
    166 (88.7 to 310.6)
    150.9 (62.7 to 363.1)
    Notes
    [19] - This outcome measure was assessed only at Day 42 and Month 6 for the Flu BS2 Group.
    [20] - This outcome measure was assessed only at Day 42 and Month 6 for the Flu BS2 Group.
    No statistical analyses for this end point

    Secondary: Humoral immune response in terms of neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) vaccine strain

    		 Close Top of page
    End point title
    		 Humoral immune response in terms of neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) vaccine strain [21]
    End point description
    Antibody titers were expressed as Geometric mean titers (GMTs). This analysis was conducted on a subset of one third of the subjects who were randomly selected.
    End point type
    Secondary
    End point timeframe
    At Month 12
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Number of subjects analysed
    11
    12
    12
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1
    152.3 (88.8 to 261)
    129.9 (71.2 to 236.8)
    138.3 (71.6 to 267.2)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) virus strain

    		 Close Top of page
    End point title
    		 Number of seroconverted subjects for neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) virus strain [22]
    End point description
    A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years. This analysis was conducted on a subset of one third of the subjects who were randomly selected.
    End point type
    Secondary
    End point timeframe
    At Day 21 and Day 42
    Notes
    [22] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
    Number of subjects analysed
    16
    15
    14
    Units: Subjects
        H1N1, Day 21
    8
    10
    9
        H1N1, Day 42
    15
    15
    14
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) virus strain

    		 Close Top of page
    End point title
    		 Number of seroconverted subjects for neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) virus strain [23]
    End point description
    A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years. This analysis was conducted on a subset of one third of the subjects who were randomly selected.
    End point type
    Secondary
    End point timeframe
    At Month 6
    Notes
    [23] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
    Number of subjects analysed
    16
    15
    13
    Units: Subjects
        H1N1
    16
    14
    12
    No statistical analyses for this end point

    Secondary: Number of subjects reporting Any and Grade 3 solicited local symptoms

    		 Close Top of page
    End point title
    		 Number of subjects reporting Any and Grade 3 solicited local symptoms [24]
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school or cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. > 50mm.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period
    Notes
    [24] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu pooled_3-5 Years Group Flu pooled_6-9 Years Group Flu pooled_10-17 Years Group
    Number of subjects analysed
    60
    65
    118
    Units: Subjects
        Any Pain
    40
    49
    96
        Grade 3 Pain
    4
    9
    11
        Any Redness
    28
    28
    46
        Grade 3 Redness
    4
    2
    4
        Any Swelling
    22
    22
    46
        Grade 3 Swelling
    2
    3
    10
    No statistical analyses for this end point

    Secondary: Number of subjects reporting Any, Grade 3 and Related solicited general symptoms

    		 Close Top of page
    End point title
    		 Number of subjects reporting Any, Grade 3 and Related solicited general symptoms [25]
    End point description
    Solicited general symptoms assessed were arthralgia, diarrhoea, drowsiness, fatigue, gastro-intestinal symptoms, headache, irritability, loss of appetite, myalgia, shivering, sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period
    Notes
    [25] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu pooled_3-5 Years Group Flu pooled_6-9 Years Group Flu pooled_10-17 Years Group
    Number of subjects analysed
    60
    65
    118
    Units: Subjects
        Any Arthralgia
    0
    14
    25
        Grade 3 Arthralgia
    0
    1
    3
        Related Arthralgia
    0
    14
    23
        Any Diarrhoea
    9
    0
    0
        Grade 3 Diarrhoea
    2
    0
    0
        Related Diarrhoea
    5
    0
    0
        Any Drowsiness
    20
    0
    0
        Grade 3 Drowsiness
    3
    0
    0
        Related Drowsiness
    18
    0
    0
        Any Fatigue
    0
    24
    53
        Grade 3 Fatigue
    0
    4
    6
        Related Fatigue
    0
    23
    50
        Any Gastro-intestinal symptoms
    0
    13
    30
        Garde 3 Gastro-intestinal symptoms
    0
    1
    5
        Related Gastro-intestinal symptoms
    0
    10
    23
        Any Headache
    0
    19
    61
        Grade 3 Headache
    0
    4
    10
        Related Headache
    0
    19
    56
        Any Irritability
    18
    0
    0
        Grade 3 Irritability
    1
    0
    0
        Related Irritability
    18
    0
    0
        Any Loss of appetite
    18
    0
    0
        Grade 3 Loss of appetite
    1
    0
    0
        Related Loss of appetite
    17
    0
    0
        Any Myalgia
    0
    13
    45
        Grade 3 Myalgia
    0
    1
    3
        Related Myalgia
    0
    13
    43
        Any Shivering
    10
    10
    35
        Grade 3 Shivering
    0
    0
    3
        Related Shivering
    9
    9
    33
        Any Sweating
    9
    10
    18
        Grade 3 Sweating
    0
    0
    1
        Related Sweating
    8
    9
    15
        Any Fever (≥37.5°C)
    27
    13
    30
        Grade 3 Fever (>39°C)
    4
    3
    4
        Related Fever
    23
    11
    23
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any Medically Attended Adverse Events (MAEs)

    		 Close Top of page
    End point title
    		 Number of subjects reporting any Medically Attended Adverse Events (MAEs) [26]
    End point description
    MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to Month 12)
    Notes
    [26] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Number of subjects analysed
    31
    31
    60
    30
    34
    58
    Units: Subjects
        Subjects with any MAE(s)
    22
    19
    36
    24
    16
    34
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any Adverse Events of Specific Interest (AESI)/potential immune-mediated diseases (pIMDs)

    		 Close Top of page
    End point title
    		 Number of subjects reporting any Adverse Events of Specific Interest (AESI)/potential immune-mediated diseases (pIMDs) [27]
    End point description
    Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune etiology. “Any pIMD” was defined as at least one pIMD experienced by the study subject.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to Month 12)
    Notes
    [27] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu pooled_3-5 Years Group Flu pooled_6-9 Years Group Flu pooled_10-17 Years Group
    Number of subjects analysed
    61
    65
    118
    Units: Subjects
        Subjects with any AESI(s)/pIMD(s)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs).

    		 Close Top of page
    End point title
    		 Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs). [28]
    End point description
    An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
    Notes
    [28] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu pooled_3-5 Years Group Flu pooled_6-9 Years Group Flu pooled_10-17 Years Group
    Number of subjects analysed
    61
    65
    118
    Units: Subjects
        Any AE(s)
    42
    25
    53
        Grade 3 AE(s)
    3
    1
    5
        Related AE(s)
    9
    2
    4
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects reporting any and related serious adverse events (SAEs) [29]
    End point description
    A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to Month 12)
    Notes
    [29] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Number of subjects analysed
    31
    31
    60
    30
    34
    58
    Units: Subjects
        Any SAE(s)
    1
    1
    1
    1
    0
    3
        Related SAE(s)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with normal and abnormal haematological and biochemistry parameters with respect to Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated / Direct,Creatine and Blood urea nitrogen(BUN)

    		 Close Top of page
    End point title
    		 Number of subjects with normal and abnormal haematological and biochemistry parameters with respect to Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated / Direct,Creatine and Blood urea nitrogen(BUN) [30]
    End point description
    Subjects were categorized by age and according to their results at pre-vaccination (Day 0), Day 21, Day 42 and Month 6 which were below, within and above the normal ranges or unknown
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21, Day 42 and Month 6 (M6)
    Notes
    [30] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Number of subjects analysed
    31
    31
    60
    26 [31]
    33 [32]
    58 [33]
    Units: Subjects
        ALAT, Day 0 Unknown
    1
    1
    1
    0
    0
    0
        ALAT, Day 0 Below
    0
    0
    0
    0
    0
    0
        ALAT, Day 0 Within
    29
    30
    58
    0
    0
    0
        ALAT, Day 0 Above
    0
    0
    1
    0
    0
    0
        ALAT, Day 21 Unknown
    1
    0
    1
    0
    0
    0
        ALAT, Day 21 Below
    0
    0
    0
    0
    0
    0
        ALAT, Day 21 Within
    30
    30
    58
    0
    0
    0
        ALAT, Day 21 Above
    0
    0
    0
    0
    0
    0
        ALAT, Day 42 Unknown
    0
    0
    2
    0
    0
    0
        ALAT, Day 42 Below
    0
    0
    0
    0
    0
    0
        ALAT, Day 42 Within
    31
    30
    55
    26
    32
    56
        ALAT, Day 42 Above
    0
    0
    1
    0
    1
    1
        ALAT, M6 Unknown
    0
    0
    1
    0
    0
    0
        ALAT, M6 Below
    0
    0
    0
    0
    0
    0
        ALAT, M6 Within
    30
    29
    56
    24
    29
    52
        ALAT, M6 Above
    0
    0
    1
    0
    0
    1
        ASAT, Day 0 Unknown
    1
    1
    1
    0
    0
    0
        ASAT, Day 0 Below
    0
    0
    0
    0
    0
    0
        ASAT, Day 0 Within
    26
    29
    58
    0
    0
    0
        ASAT, Day 0 Above
    3
    1
    1
    0
    0
    0
        ASAT, Day 21 Unknown
    1
    0
    1
    0
    0
    0
        ASAT, Day 21 Below
    0
    0
    0
    0
    0
    0
        ASAT, Day 21 Within
    30
    29
    58
    0
    0
    0
        ASAT, Day 21 Above
    0
    1
    0
    0
    0
    0
        ASAT, Day 42 Unknown
    0
    1
    2
    0
    0
    0
        ASAT, Day 42 Below
    0
    0
    0
    0
    0
    0
        ASAT, Day 42 Within
    31
    29
    55
    25
    31
    55
        ASAT, Day 42 Above
    0
    0
    1
    1
    2
    2
        ASAT, M6 Unknown
    0
    0
    1
    0
    0
    0
        ASAT, M6 Below
    0
    0
    0
    0
    0
    0
        ASAT, M6 Within
    30
    28
    57
    24
    29
    50
        ASAT, M6 Above
    0
    1
    0
    0
    0
    3
        Total Bilirubin, Day 0 Unknown
    1
    1
    1
    0
    0
    0
        Total Bilirubin, Day 0 Below
    0
    0
    0
    0
    0
    0
        Total Bilirubin, Day 0 Within
    29
    28
    57
    0
    0
    0
        Total Bilirubin, Day 0 Above
    0
    2
    2
    0
    0
    0
        Total Bilirubin, Day 21 Unknown
    1
    0
    1
    0
    0
    0
        Total Bilirubin, Day 21 Below
    0
    0
    0
    0
    0
    0
        Total Bilirubin, Day 21 Within
    30
    28
    55
    0
    0
    0
        Total Bilirubin, Day 21 Above
    0
    2
    3
    0
    0
    0
        Total Bilirubin, Day 42 Unknown
    0
    0
    2
    0
    0
    0
        Total Bilirubin, Day 42 Below
    0
    0
    0
    0
    0
    0
        Total Bilirubin, Day 42 Within
    31
    30
    55
    26
    33
    55
        Total Bilirubin, Day 42 Above
    0
    0
    1
    0
    0
    2
        Total Bilirubin, M6 Unknown
    0
    0
    1
    0
    0
    0
        Total Bilirubin, M6 Below
    0
    0
    0
    0
    0
    0
        Total Bilirubin, M6 Within
    30
    28
    55
    24
    29
    51
        Total Bilirubin, M6 Above
    0
    1
    2
    0
    0
    2
        Bilirubin Conjugated / Direct, Day 0 Unknown
    1
    1
    1
    0
    0
    0
        Bilirubin Conjugated / Direct, Day 0 Below
    0
    0
    0
    0
    0
    0
        Bilirubin Conjugated / Direct, Day 0 Within
    29
    30
    58
    0
    0
    0
        Bilirubin Conjugated / Direct, Day 0 Above
    0
    0
    1
    0
    0
    0
        Bilirubin Conjugated / Direct, Day 21 Unknown
    1
    0
    1
    0
    0
    0
        Bilirubin Conjugated / Direct, Day 21 Below
    0
    0
    0
    0
    0
    0
        Bilirubin Conjugated / Direct, Day 21 Within
    30
    30
    58
    0
    0
    0
        Bilirubin Conjugated / Direct, Day 21 Above
    0
    0
    0
    0
    0
    0
        Bilirubin Conjugated / Direct, Day 42 Unknown
    0
    0
    2
    0
    0
    0
        Bilirubin Conjugated / Direct, Day 42 Below
    0
    0
    0
    0
    0
    0
        Bilirubin Conjugated / Direct, Day 42 Within
    31
    30
    56
    26
    33
    57
        Bilirubin Conjugated / Direct, Day 42 Above
    0
    0
    0
    0
    0
    0
        Bilirubin Conjugated / Direct, M6 Unknown
    0
    0
    1
    0
    0
    0
        Bilirubin Conjugated / Direct, M6 Below
    0
    0
    0
    0
    0
    0
        Bilirubin Conjugated / Direct, M6 Within
    30
    29
    57
    24
    29
    53
        Bilirubin Conjugated / Direct, M6 Above
    0
    0
    0
    0
    0
    0
        Creatine, Day 0 Unknown
    1
    1
    1
    0
    0
    0
        Creatine, Day 0 Below
    2
    0
    1
    0
    0
    0
        Creatine, Day 0 Within
    27
    29
    52
    0
    0
    0
        Creatine, Day 0 Above
    0
    1
    6
    0
    0
    0
        Creatine, Day 21 Unknown
    1
    0
    1
    0
    0
    0
        Creatine, Day 21 Below
    3
    0
    4
    0
    0
    0
        Creatine, Day 21 Within
    27
    28
    48
    0
    0
    0
        Creatine, Day 21 Above
    0
    2
    6
    0
    0
    0
        Creatine, Day 42 Unknown
    0
    0
    2
    0
    0
    0
        Creatine, Day 42 Below
    2
    1
    3
    0
    1
    2
        Creatine, Day 42 Within
    28
    29
    52
    24
    31
    51
        Creatine, Day 42 Above
    1
    0
    1
    2
    1
    4
        Creatine, M6 Unknown
    0
    0
    1
    0
    0
    0
        Creatine, M6 Below
    1
    1
    2
    1
    0
    5
        Creatine, M6 Within
    28
    28
    55
    22
    29
    47
        Creatine, M6 Above
    1
    0
    0
    1
    0
    1
        BUN, Day 0 Unknown
    1
    1
    1
    0
    0
    0
        BUN, Day 0 Below
    0
    0
    2
    0
    0
    0
        BUN, Day 0 Within
    28
    30
    57
    0
    0
    0
        BUN, Day 0 Above
    1
    0
    0
    0
    0
    0
        BUN, Day 21 Unknown
    1
    0
    1
    0
    0
    0
        BUN, Day 21 Below
    1
    2
    3
    0
    0
    0
        BUN, Day 21 Within
    29
    27
    55
    0
    0
    0
        BUN, Day 21 Above
    0
    1
    0
    0
    0
    0
        BUN, Day 42 Unknown
    0
    0
    2
    0
    0
    0
        BUN, Day 42 Below
    1
    2
    1
    1
    0
    0
        BUN, Day 42 Within
    29
    28
    55
    23
    32
    56
        BUN, Day 42 Above
    1
    0
    0
    2
    1
    1
        BUN, M6 Unknown
    1
    0
    1
    0
    0
    0
        BUN, M6 Below
    1
    0
    2
    0
    0
    0
        BUN, M6 Within
    27
    28
    54
    24
    27
    53
        BUN, M6 Above
    1
    1
    1
    0
    2
    0
    Notes
    [31] - The outcome measure for the Flu BS2_3-5 Group was assessed at Day 42 and Month 6 only.
    [32] - The outcome measure for the Flu BS2_6-9 Group was assessed at Day 42 and Month 6 only.
    [33] - The outcome measure for the Flu BS2_10-17 Group was assessed at Day 42 and Month 6 only.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    SAEs:During the entire study period(Day 0 to Month 6), Solicited local and general symptoms: During the 7-day(Days 0-6) post-vaccination period; Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Flu BS1_3-5 Years Group
    Reporting group description
    		 Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination);

    Reporting group title
    Flu BS1_6-9 Years Group
    Reporting group description
    		 Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination);

    Reporting group title
    Flu BS1_10-17 Years Group
    Reporting group description
    		 Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination);

    Reporting group title
    Flu BS2_3-5 Years Group
    Reporting group description
    		 Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).

    Reporting group title
    Flu BS2_6-9 Years Group
    Reporting group description
    		 Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).

    Reporting group title
    Flu BS2_10-17 Years Group
    Reporting group description
    		 Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).

    Serious adverse events
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    1 / 60 (1.67%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    3 / 58 (5.17%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ranula
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 60 (1.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Febrile infection
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 31 (96.77%)
    25 / 31 (80.65%)
    56 / 60 (93.33%)
    26 / 30 (86.67%)
    26 / 34 (76.47%)
    50 / 58 (86.21%)
    Nervous system disorders
    Headache (Non-systematic)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 31 (3.23%)
    9 / 31 (29.03%)
    30 / 60 (50.00%)
    4 / 30 (13.33%)
    10 / 34 (29.41%)
    31 / 58 (53.45%)
         occurrences all number
    1
    14
    47
    4
    13
    50
    Somnolence
         subjects affected / exposed
    11 / 31 (35.48%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    9 / 30 (30.00%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    16
    0
    0
    11
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    15 / 31 (48.39%)
    7 / 31 (22.58%)
    19 / 60 (31.67%)
    15 / 30 (50.00%)
    9 / 34 (26.47%)
    12 / 58 (20.69%)
         occurrences all number
    22
    10
    22
    22
    11
    14
    Influenza like illness
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    2 / 60 (3.33%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    4 / 58 (6.90%)
         occurrences all number
    1
    1
    2
    1
    0
    4
    Pain
         subjects affected / exposed
    19 / 31 (61.29%)
    24 / 31 (77.42%)
    51 / 60 (85.00%)
    21 / 30 (70.00%)
    25 / 34 (73.53%)
    45 / 58 (77.59%)
         occurrences all number
    29
    40
    92
    38
    42
    75
    Swelling
         subjects affected / exposed
    13 / 31 (41.94%)
    13 / 31 (41.94%)
    21 / 60 (35.00%)
    9 / 30 (30.00%)
    9 / 34 (26.47%)
    25 / 58 (43.10%)
         occurrences all number
    16
    18
    28
    13
    13
    38
    Arthralgia
         subjects affected / exposed
    0 / 31 (0.00%)
    7 / 31 (22.58%)
    11 / 60 (18.33%)
    2 / 30 (6.67%)
    7 / 34 (20.59%)
    14 / 58 (24.14%)
         occurrences all number
    0
    10
    14
    2
    9
    17
    Diarrhoea
         subjects affected / exposed
    6 / 31 (19.35%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    4 / 30 (13.33%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    7
    0
    0
    5
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 31 (0.00%)
    13 / 31 (41.94%)
    29 / 60 (48.33%)
    0 / 30 (0.00%)
    11 / 34 (32.35%)
    24 / 58 (41.38%)
         occurrences all number
    0
    18
    37
    0
    15
    36
    Gastro-intestinal symptoms
         subjects affected / exposed
    0 / 31 (0.00%)
    7 / 31 (22.58%)
    18 / 60 (30.00%)
    0 / 30 (0.00%)
    6 / 34 (17.65%)
    12 / 58 (20.69%)
         occurrences all number
    0
    11
    21
    0
    7
    13
    Headache (Systematic)
         subjects affected / exposed
    1 / 31 (3.23%)
    9 / 31 (29.03%)
    30 / 60 (50.00%)
    4 / 30 (13.33%)
    10 / 34 (29.41%)
    31 / 58 (53.45%)
         occurrences all number
    1
    14
    47
    4
    13
    50
    Irritability
         subjects affected / exposed
    9 / 31 (29.03%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    9 / 30 (30.00%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    13
    0
    0
    14
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 31 (0.00%)
    6 / 31 (19.35%)
    21 / 60 (35.00%)
    1 / 30 (3.33%)
    7 / 34 (20.59%)
    24 / 58 (41.38%)
         occurrences all number
    0
    10
    26
    1
    12
    29
    Chills
         subjects affected / exposed
    7 / 31 (22.58%)
    7 / 31 (22.58%)
    18 / 60 (30.00%)
    3 / 30 (10.00%)
    3 / 34 (8.82%)
    17 / 58 (29.31%)
         occurrences all number
    11
    8
    24
    4
    4
    22
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 31 (3.23%)
    0 / 60 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    3
    1
    0
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 31 (16.13%)
    1 / 31 (3.23%)
    0 / 60 (0.00%)
    5 / 30 (16.67%)
    2 / 34 (5.88%)
    2 / 58 (3.45%)
         occurrences all number
    7
    1
    0
    10
    3
    3
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    14 / 31 (45.16%)
    16 / 31 (51.61%)
    23 / 60 (38.33%)
    14 / 30 (46.67%)
    12 / 34 (35.29%)
    23 / 58 (39.66%)
         occurrences all number
    18
    20
    34
    21
    16
    30
    Hyperhidrosis
         subjects affected / exposed
    4 / 31 (12.90%)
    4 / 31 (12.90%)
    9 / 60 (15.00%)
    5 / 30 (16.67%)
    6 / 34 (17.65%)
    9 / 58 (15.52%)
         occurrences all number
    4
    4
    10
    6
    6
    10
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 31 (6.45%)
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 31 (3.23%)
    5 / 60 (8.33%)
    4 / 30 (13.33%)
    0 / 34 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    4
    2
    5
    5
    0
    3
    Nasopharyngitis
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    3 / 60 (5.00%)
    4 / 30 (13.33%)
    2 / 34 (5.88%)
    4 / 58 (6.90%)
         occurrences all number
    3
    0
    4
    6
    2
    5
    Rhinitis
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 31 (3.23%)
    2 / 60 (3.33%)
    2 / 30 (6.67%)
    1 / 34 (2.94%)
    1 / 58 (1.72%)
         occurrences all number
    3
    1
    2
    2
    1
    1
    Bronchitis
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    2 / 60 (3.33%)
    4 / 30 (13.33%)
    0 / 34 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    2
    0
    2
    5
    0
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 60 (0.00%)
    2 / 30 (6.67%)
    0 / 34 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    2
    0
    0
    2
    0
    1
    Lice infestation
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    0 / 60 (0.00%)
    2 / 30 (6.67%)
    1 / 34 (2.94%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    0
    2
    1
    1
    Otitis externa
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    1 / 60 (1.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    2
    0
    1
    0
    0
    1
    Otitis media
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 60 (1.67%)
    2 / 30 (6.67%)
    0 / 34 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    Viral infection
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 31 (6.45%)
    1 / 60 (1.67%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    2
    2
    1
    1
    0
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Aug 2010
    Following the very high immune response after the first two doses of vaccine, in addition to the decreased perception of the pandemic threat by the public and in the light of a potential increase of overall reactogenicity, the added value of the booster dose was considered limited by the investigators. Thus no subject enrolled in Flu D-Pan H1N1-023 study were vaccinated with the booster dose. The safety follow-up was thus reduced to Month 12, i.e. 12 months after the first vaccination, instead of 12 months after the booster dose.

    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-Sat Apr 20 09:12:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA