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    Clinical Trial Results:
    A Phase III Open, Randomized, Parallel, Multi-Center Study in Children Aged 6 - <36 Months to Compare the Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-Dose Regimen of Inflexal V Administered According to a 0/4 Week Schedule and Followed-up for 6 Months

    Summary
    EudraCT number
    		 2010-019745-25
    Trial protocol
    		 IT  
    Global end of trial date
    29 Jul 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Jun 2016
    First version publication date
    08 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    INF-V-A005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01229397
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Crucell Switzerland AG
    Sponsor organisation address
    Rehhagstrasse 79, Bern, Switzerland, 3018
    Public contact
    Crucell Switzerland AG, Clinical Registry Group, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Crucell Switzerland AG, Clinical Registry Group, ClinicalTrialsEU@its.jnj.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
    29 Jul 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the immunogenicity of a single full (0.5 milliliter [mL]) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - less than (<) 36 months, using the European Medicines Agency (EMA)/Committee for Medicinal Products for Human Use (CHMP) guideline for the re-registration of the seasonal influenza vaccine in adults (aged greater than or equal to [>=] 18 - less than or equal to [<=] 60 years) as reference.
    Protection of trial subjects
    The participants were observed closely for at least 30 minutes after vaccination with appropriate medical treatment readily available in case of rare anaphylactic reaction Local solicited adverse events (30 min after vaccination) were evaluated by the investigator. Each participant's parents or legal guardians received a Participant Diary and were requested to record all adverse events (AEs) and body temperature on the day of vaccination and on the following 3 days. All AEs, including serious adverse events (SAEs), as well as concomitant medications were evaluated at each visit throughout the study. The parents or legal guardians were instructed to contact the investigator immediately should the participant experience any signs or symptoms they perceive as serious during the period extending from the first study-specific procedure up to and including 6 months after administration of the investigational medicinal product (IMP). The tolerability of the 2 dose regimens of the study vaccine was assessed by the participants' parents/legal guardians and by the investigator 4 weeks after completion of vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Oct 2010
    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
    Italy: 205
    Worldwide total number of subjects
    205
    EEA total number of subjects
    205
    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)
    85
    Children (2-11 years)
    120
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: 05 October - 17 January 2011; Location: University of Milan

    Pre-assignment
    Screening details
    		 A total of 205 participants were enrolled and vaccinated with Inflexal and included in the all randomized population set.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Inflexal V 0.25 mL x 2
    Arm description
    		 2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 milliliter (mL) dose: • 7.5 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus
    Arm type
    		 Active comparator

    Investigational medicinal product name
    INFLEXAL V
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Inflexal V 0.25 milliliter (mL) intramuscular injection twice, 4 weeks apart

    Arm title
    		 Inflexal V 0.5 mL x 1
    Arm description
    		 1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 milliliter (mL) dose: • 15 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 15 μg HA antigen of B/Brisbane/60/2008-like virus
    Arm type
    		 Experimental

    Investigational medicinal product name
    INFLEXAL V
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Inflexal V 0.5 milliliter (mL) intramuscular injection once only

    Number of subjects in period 1
    		Inflexal V 0.25 mL x 2 Inflexal V 0.5 mL x 1
    Started
    103
    102
    Completed
    92
    93
    Not completed
    11
    9
         Consent withdrawn by subject
    3
    3
         Migrated/moved from study area
    1
    -
         Lost to follow-up
    7
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Inflexal V 0.25 mL x 2
    Reporting group description
    		 2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 milliliter (mL) dose: • 7.5 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus

    Reporting group title
    Inflexal V 0.5 mL x 1
    Reporting group description
    		 1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 milliliter (mL) dose: • 15 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 15 μg HA antigen of B/Brisbane/60/2008-like virus

    Reporting group values
    		 Inflexal V 0.25 mL x 2 Inflexal V 0.5 mL x 1 Total
    Number of subjects
    		 103 102 205
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 43 42 85
        Children (2-11 years)
    		 60 60 120
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 1.8 ( 0.52 ) 1.8 ( 0.61 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 37 74
        Male
    		 66 65 131
    Subject analysis sets

    Subject analysis set title
    Inflexal V 0.25 mL x 2 - After 1st Vaccination
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 milliliter (mL) dose: • 7.5 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus

    Subject analysis set title
    Inflexal V 0.25 mL x 2 - After 2nd Vaccination
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 milliliter (mL) dose: • 7.5 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus

    Subject analysis sets values
    		 Inflexal V 0.25 mL x 2 - After 1st Vaccination Inflexal V 0.25 mL x 2 - After 2nd Vaccination
    Number of subjects
    102
    101
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    42
    42
        Children (2-11 years)
    60
    59
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Inflexal V 0.25 mL x 2
    Reporting group description
    		 2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 milliliter (mL) dose: • 7.5 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus

    Reporting group title
    Inflexal V 0.5 mL x 1
    Reporting group description
    		 1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 milliliter (mL) dose: • 15 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 15 μg HA antigen of B/Brisbane/60/2008-like virus

    Subject analysis set title
    Inflexal V 0.25 mL x 2 - After 1st Vaccination
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 milliliter (mL) dose: • 7.5 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus

    Subject analysis set title
    Inflexal V 0.25 mL x 2 - After 2nd Vaccination
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 milliliter (mL) dose: • 7.5 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus

    Primary: Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the European Medicines Agency (EMA) Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults as Reference

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    End point title
    		 Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the European Medicines Agency (EMA) Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults as Reference [1]
    End point description
    Seroprotection rate.
    End point type
    Primary
    End point timeframe
    This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Inflexal V 0.25 mL x 2 Inflexal V 0.5 mL x 1
    Number of subjects analysed
    98
    99
    Units: Participants
    number (confidence interval 95%)
        Percentage of participants seroprotected: A/H1N1
    99 (94.4 to 100)
    98 (92.9 to 99.8)
        Percentage of participants seroprotected: A/H3N2
    99 (94.4 to 100)
    97 (91.4 to 99.4)
        Percentage of participants seroprotected: B-strain
    92.9 (85.8 to 97.1)
    86.9 (78.6 to 92.8)
    No statistical analyses for this end point

    Primary: Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the European Medicines Agency (EMA) Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults as Reference

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    End point title
    		 Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the European Medicines Agency (EMA) Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults as Reference [2]
    End point description
    Seroconversion rate.
    End point type
    Primary
    End point timeframe
    This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Inflexal V 0.25 mL x 2 Inflexal V 0.5 mL x 1
    Number of subjects analysed
    98
    99
    Units: Participants
    number (confidence interval 95%)
        Percentage of participants seroconverted: A/H1N1
    99 (94.4 to 100)
    98 (92.9 to 99.8)
        Percentage of participants seroconverted: A/H3N2
    99 (94.4 to 100)
    97 (91.4 to 99.4)
        Percentage of participants seroconverted: B-strain
    92.9 (85.8 to 97.1)
    86.9 (78.6 to 92.8)
    No statistical analyses for this end point

    Primary: Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the European Medicines Agency (EMA) Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults as Reference

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    End point title
    		 Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the European Medicines Agency (EMA) Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults as Reference [3]
    End point description
    GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value.
    End point type
    Primary
    End point timeframe
    This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Inflexal V 0.25 mL x 2 Inflexal V 0.5 mL x 1
    Number of subjects analysed
    98
    99
    Units: Participants
    number (confidence interval 95%)
        GMT fold increase from baseline: A/H1N1
    25.5 (21.3 to 30.5)
    19.6 (16.9 to 22.7)
        GMT fold increase from baseline: A/H3N2
    31.6 (26.7 to 37.3)
    24.6 (20.7 to 29.3)
        GMT fold increase from baseline: B-strain
    12.8 (11.2 to 14.6)
    14.7 (12.3 to 17.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Local and Systemic Adverse Events (AE) as a Measure of Safety and Tolerability

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    End point title
    		 Percentage of Participants With Local and Systemic Adverse Events (AE) as a Measure of Safety and Tolerability [4]
    End point description
    Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary.
    End point type
    Secondary
    End point timeframe
    Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For this endpoint Inflexal V 0.5 mL x 1, Inflexal V 0.25mL x 2 - After 1st Vaccination, Inflexal V 0.25mL x 2 - After2nd Vaccination reporting groups were only analysed.
    End point values
    		 Inflexal V 0.5 mL x 1 Inflexal V 0.25 mL x 2 - After 1st Vaccination Inflexal V 0.25 mL x 2 - After 2nd Vaccination
    Number of subjects analysed
    100
    102
    101
    Units: Percentage of participants
    number (not applicable)
        AEs (unsolicited and solicited)
    49
    50
    47.5
        Unsolicited AEs
    30
    28.4
    31.7
        Solicited local AEs
    17.2
    22.4
    17.2
        Solicited systemic AEs
    20.2
    16.3
    17.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any Adverse event (AE) occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any serious adverse events (SAE) occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Inflexal V 0.25 mL x 2 - After 1st Vaccination
    Reporting group description
    		 Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 milliliter (mL) dose: • 7.5 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus

    Reporting group title
    Inflexal V 0.5 mL x 1
    Reporting group description
    		 1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 milliliter (mL) dose: • 15 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 15 μg HA antigen of B/Brisbane/60/2008-like virus

    Reporting group title
    Inflexal V 0.25 mL x 2 - After 2nd Vaccination
    Reporting group description
    		 Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 milliliter (mL) dose: • 7.5 microgram (μg) HA antigen of A/California/7/2009 (H1N1)-like virus • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus

    Serious adverse events
    		 Inflexal V 0.25 mL x 2 - After 1st Vaccination Inflexal V 0.5 mL x 1 Inflexal V 0.25 mL x 2 - After 2nd Vaccination
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 102 (0.98%)
    4 / 100 (4.00%)
    0 / 101 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary Disease
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenterisits rotavirus
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Inflexal V 0.25 mL x 2 - After 1st Vaccination Inflexal V 0.5 mL x 1 Inflexal V 0.25 mL x 2 - After 2nd Vaccination
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 102 (50.00%)
    49 / 100 (49.00%)
    48 / 101 (47.52%)
    General disorders and administration site conditions
    Pyrexia unsolicited
         subjects affected / exposed
    11 / 102 (10.78%)
    9 / 100 (9.00%)
    10 / 101 (9.90%)
         occurrences all number
    11
    9
    13
    Erythema (at the injection site)
         subjects affected / exposed
    15 / 102 (14.71%)
    10 / 100 (10.00%)
    7 / 101 (6.93%)
         occurrences all number
    15
    10
    7
    Induration (at the injection site)
         subjects affected / exposed
    7 / 102 (6.86%)
    6 / 100 (6.00%)
    2 / 101 (1.98%)
         occurrences all number
    7
    6
    2
    Pain (at the injection site)
         subjects affected / exposed
    11 / 102 (10.78%)
    9 / 100 (9.00%)
    10 / 101 (9.90%)
         occurrences all number
    11
    9
    10
    Haemorrhage (at the injection site)
         subjects affected / exposed
    3 / 102 (2.94%)
    5 / 100 (5.00%)
    4 / 101 (3.96%)
         occurrences all number
    3
    5
    4
    Malaise
         subjects affected / exposed
    9 / 102 (8.82%)
    7 / 100 (7.00%)
    8 / 101 (7.92%)
         occurrences all number
    9
    7
    8
    Pyrexia solicited
         subjects affected / exposed
    8 / 102 (7.84%)
    15 / 100 (15.00%)
    11 / 101 (10.89%)
         occurrences all number
    8
    15
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 100 (3.00%)
    8 / 101 (7.92%)
         occurrences all number
    0
    3
    8
    Infections and infestations
    Otitis media acute
         subjects affected / exposed
    4 / 102 (3.92%)
    5 / 100 (5.00%)
    3 / 101 (2.97%)
         occurrences all number
    4
    5
    3
    Rhinitis
         subjects affected / exposed
    1 / 102 (0.98%)
    2 / 100 (2.00%)
    9 / 101 (8.91%)
         occurrences all number
    1
    2
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jun 2010
    The overall reason for the amendment was to introduced a 6 month follow-up visit for the participants enrolled in the study, at which an additional blood sample for immunogenicity evaluation was taken.
    20 Dec 2010
    The overall reason for the amendment was to change the principal investigator.
    06 May 2011
    The overall reason for the amendment was to establish second interim analysis after immunogenicity data for the follow-up visit at Day 212 (plus [+] or minus [-] 7 days) had become available for at least 70 participants in each study arm.

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

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