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    Clinical Trial Results:
    A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rLP2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To (>=) 10 To Less Than (<) 26 Years

    Summary
    EudraCT number
    		 2009-015198-11
    Trial protocol
    		 SE   CZ   LT   EE   FI   DK   ES   DE   Outside EU/EEA  
    Global end of trial date
    29 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2016
    First version publication date
    29 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B1971014 (6108A1-3003)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01352793
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Clinical Trials.gov Call Centre, Pfizer Inc, 001 8007181021, ClinicalTrials.govCallCentre@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Centre, Pfizer Inc, 001 8007181021, ClinicalTrials.govCallCentre@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001037-PIP02-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of bivalent rLP2086 vaccine compared to a control (hepatitis A virus [HAV] vaccine/saline), as assessed by serious adverse events (SAEs) and medically attended adverse events.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 HAV vaccine (at months 0 and 6) has been chosen as the control in this study because there is no proven safe, immunogenic, and effective vaccine against MnB that could serve as an active control. In comparison to other recommended vaccines for this age group, HAV vaccine has a well-established tolerability profile. In addition, HAV vaccine will confer a benefit to subjects who may become at increased risk for hepatitis A viral infection either during future travel or other exposures. The generally recommended regimen for HAV vaccine is 2 doses at 0 and 6 months. In this study, saline is given at month 2 to maintain the study blind.
    Actual start date of recruitment
    07 Nov 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 873
    Country: Number of subjects enrolled
    Spain: 150
    Country: Number of subjects enrolled
    Sweden: 72
    Country: Number of subjects enrolled
    Czech Republic: 309
    Country: Number of subjects enrolled
    Denmark: 255
    Country: Number of subjects enrolled
    Estonia: 250
    Country: Number of subjects enrolled
    Finland: 287
    Country: Number of subjects enrolled
    Germany: 195
    Country: Number of subjects enrolled
    Lithuania: 438
    Country: Number of subjects enrolled
    United States: 2344
    Country: Number of subjects enrolled
    Australia: 205
    Country: Number of subjects enrolled
    Chile: 334
    Worldwide total number of subjects
    5712
    EEA total number of subjects
    2829
    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)
    730
    Adolescents (12-17 years)
    2127
    Adults (18-64 years)
    2855
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 5712 subjects in 12 countries were enrolled in this study. Of these, 8 subjects were randomized but did not receive study vaccination.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: rLP2086
    Arm description
    		 Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
    Arm type
    		 Experimental

    Investigational medicinal product name
    rLP2086
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received rLP2086 vaccine 120 microgram (mcg) intramuscularly in the deltoid muscle on a 0, 2­, 6­ month schedule.

    Arm title
    		 Group 2: HAV/Saline/HAV
    Arm description
    		 Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
    Arm type
    		 Active comparator

    Investigational medicinal product name
    HAV vaccine
    Investigational medicinal product code
    Other name
    Havrix
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received HAV vaccine (Havrix) 0.5 milliliter (mL) pediatric dose containing 720 enzyme­linked immunosorbent assay (ELISA) units (EL.U.) or 1.0 mL adult dose containing 1440 EL.U based on subject’s age intramuscularly in the deltoid muscle on a 0­, 6­ month schedule. 

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of normal saline injection at Month 2.

    Number of subjects in period 1
    		Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Started
    3804
    1908
    Vaccination 1
    3796
    1908
    Vaccination 2
    3530
    1806
    Vaccination 3
    3314
    1710
    Completed
    3219
    1663
    Not completed
    585
    245
         Physician decision
    1
    -
         Adverse Event
    44
    10
         No longer meets eligibility criteria
    25
    15
         Death
    1
    -
         Randomized but not vaccinated
    8
    -
         Pregnancy
    26
    8
         Medication error
    2
    2
         Withdrawal by Subject
    120
    55
         Protocol Violation
    44
    23
         Unspecified
    25
    7
         Lost to follow-up
    289
    125

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: rLP2086
    Reporting group description
    		 Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule

    Reporting group title
    Group 2: HAV/Saline/HAV
    Reporting group description
    		 Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month

    Reporting group values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV Total
    Number of subjects
    		 3804 1908 5712
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 17.4 ( 4.6 ) 17.4 ( 4.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1962 994 2956
        Male
    		 1842 914 2756

    End points

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    End points reporting groups
    Reporting group title
    Group 1: rLP2086
    Reporting group description
    		 Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule

    Reporting group title
    Group 2: HAV/Saline/HAV
    Reporting group description
    		 Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month

    Primary: Percentage of Subjects With at Least One Serious Adverse Event (SAE) Throughout the Study

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    End point title
    		 Percentage of Subjects With at Least One Serious Adverse Event (SAE) Throughout the Study [1]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subject who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Safety population included all subjects who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
    End point type
    Primary
    End point timeframe
    Vaccination 1 up to 6 months after Vaccination 3
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Number of subjects analysed
    3796
    1908
    Units: percentage of subjects
        number (confidence interval 95%)
    1.55 (1.2 to 2)
    2.52 (1.9 to 3.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1

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    End point title
    		 Percentage of Subjects With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 [2]
    End point description
    A medically attended AE was defined as a non-serious AE that required medical attention. Vaccination 1 safety population included all subjects who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2.
    End point type
    Primary
    End point timeframe
    Within 30 days after Vaccination 1
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Number of subjects analysed
    3796
    1908
    Units: percentage of subjects
        number (confidence interval 95%)
    7.03 (6.2 to 7.9)
    6.13 (5.1 to 7.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2

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    End point title
    		 Percentage of Subjects With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 [3]
    End point description
    A medically attended AE was defined as a non-serious AE that required medical attention. Vaccination 2 safety population included all subjects who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3.
    End point type
    Primary
    End point timeframe
    Within 30 days after Vaccination 2
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Number of subjects analysed
    3529
    1806
    Units: percentage of subjects
        number (confidence interval 95%)
    5.5 (4.8 to 6.3)
    6.09 (5 to 7.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3

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    End point title
    		 Percentage of Subjects With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 [4]
    End point description
    A medically attended AE was defined as a non-serious AE that required medical attention. Vaccination 3 safety population included all subjects who received the third dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available from Vaccination 3 to post Vaccination 3 follow-up visit (1 month after Vaccination 3).
    End point type
    Primary
    End point timeframe
    Within 30 days after Vaccination 3
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Number of subjects analysed
    3313
    1710
    Units: percentage of subjects
        number (confidence interval 95%)
    5.34 (4.6 to 6.2)
    5.5 (4.5 to 6.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least One Serious Adverse Event (SAE) During Pre- specified Time Periods

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    End point title
    		 Percentage of Subjects With at Least One Serious Adverse Event (SAE) During Pre- specified Time Periods
    End point description
    An AE was any untoward medical occurrence in a subject who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those subjects who were evaluable for this measure during specified time period. Safety population included all subjects who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
    End point type
    Secondary
    End point timeframe
    Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)
    End point values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Number of subjects analysed
    3796
    1908
    Units: percentage of subjects
    number (confidence interval 95%)
        30 days after Vaccination 1 (N=3796, 1908)
    0.18 (0.1 to 0.4)
    0.42 (0.2 to 0.8)
        30 days after Vaccination 2 (N=3529, 1806)
    0.17 (0.1 to 0.4)
    0.44 (0.2 to 0.9)
        30 days after Vaccination 3 (N=3313, 1710)
    0.33 (0.2 to 0.6)
    0.12 (0 to 0.4)
        30 days after any vaccination (N=3796, 1908)
    0.61 (0.4 to 0.9)
    0.94 (0.6 to 1.5)
        Vaccination phase (N=3796, 1908)
    1.16 (0.8 to 1.6)
    1.83 (1.3 to 2.5)
        Follow-up phase (N=3400, 1733)
    0.44 (0.2 to 0.7)
    0.87 (0.5 to 1.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least One Medically Attended Adverse Event During Pre- specified Time Periods

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    End point title
    		 Percentage of Subjects With at Least One Medically Attended Adverse Event During Pre- specified Time Periods
    End point description
    A medically attended AE was defined as a non-serious AE that required medical attention. Safety population included all subjects who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
    End point type
    Secondary
    End point timeframe
    Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)
    End point values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Number of subjects analysed
    3796
    1908
    Units: percentage of subjects
    number (confidence interval 95%)
        30 days after any vaccination (N=3796, 1908)
    14.38 (13.3 to 15.5)
    14.57 (13 to 16.2)
        Vaccination phase (N=3796, 1908)
    24.6 (23.2 to 26)
    24.53 (22.6 to 26.5)
        Follow-up phase (N=3400, 1733)
    11.24 (10.2 to 12.3)
    11.43 (10 to 13)
        Throughout study (N=3796, 1908)
    29 (27.6 to 30.5)
    29.04 (27 to 31.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods

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    End point title
    		 Percentage of Subjects With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
    End point description
    A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those subjects who were evaluable for this measure during specified time period. Safety population included all subjects who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
    End point type
    Secondary
    End point timeframe
    Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination
    End point values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Number of subjects analysed
    3796
    1908
    Units: percentage of subjects
    number (confidence interval 95%)
        30 days after Vaccination 1 (N=3796, 1908)
    0.21 (0.1 to 0.4)
    0.1 (0 to 0.4)
        30 days after Vaccination 2 (N=3529, 1806)
    0.17 (0.1 to 0.4)
    0.33 (0.1 to 0.7)
        30 days after Vaccination 3 (N=3313, 1710)
    0.09 (0 to 0.3)
    0.12 (0 to 0.4)
        30 days after any vaccination (N=3796, 1908)
    0.45 (0.3 to 0.7)
    0.52 (0.3 to 1)
        Vaccination phase (N=3796, 1908)
    1.03 (0.7 to 1.4)
    1.05 (0.6 to 1.6)
        Follow-up phase (N=3400, 1733)
    0.44 (0.2 to 0.7)
    0.52 (0.2 to 1)
        Throughout study (N=3796, 1908)
    1.4 (1 to 1.8)
    1.52 (1 to 2.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least One Adverse Event (AE) During Pre-specified Time Periods

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    End point title
    		 Percentage of Subjects With at Least One Adverse Event (AE) During Pre-specified Time Periods
    End point description
    An AE was any untoward medical occurrence in a subject who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those subjects who were evaluable for this measure during specified time period. Safety population included all subjects who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
    End point type
    Secondary
    End point timeframe
    Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)
    End point values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Number of subjects analysed
    3796
    1908
    Units: percentage of subjects
    number (confidence interval 95%)
        30 days after Vaccination 1 (N=3796, 1908)
    31.48 (30 to 33)
    19.03 (17.3 to 20.9)
        30 days after Vaccination 2 (N=3529, 1806)
    20.37 (19.1 to 21.7)
    12.35 (10.9 to 14)
        30 days after Vaccination 3 (N=3313, 1710)
    15 (13.8 to 16.3)
    10.76 (9.3 to 12.3)
        30 days after any vaccination (N=3796, 1908)
    43.02 (41.4 to 44.6)
    31.45 (29.4 to 33.6)
        Vaccination phase (N=3796, 1908)
    51.08 (49.5 to 52.7)
    42.51 (40.3 to 44.8)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least One Immediate Adverse Event (AE) After Each Study Vaccination

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    End point title
    		 Percentage of Subjects With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
    End point description
    An AE was any untoward medical occurrence in a subject who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those subjects who were evaluable for this measure during specified time period. Safety population included all subjects who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes after Vaccination 1, 2, 3
    End point values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Number of subjects analysed
    3796
    1908
    Units: percentage of subjects
    number (confidence interval 95%)
        Vaccination 1 (N=3796, 1908)
    1.05 (0.8 to 1.4)
    0.84 (0.5 to 1.4)
        Vaccination 2 (N=3529, 1806)
    0.54 (0.3 to 0.8)
    0.06 (0 to 0.3)
        Vaccination 3 (N=3313, 1710)
    0.45 (0.3 to 0.7)
    0.41 (0.2 to 0.8)
    No statistical analyses for this end point

    Secondary: Number of Days Subject Missed School or Work Due to Adverse Events (AEs)

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    End point title
    		 Number of Days Subject Missed School or Work Due to Adverse Events (AEs)
    End point description
    Safety population included all subjects who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
    End point type
    Secondary
    End point timeframe
    Vaccination 1 up to 1 month after Vaccination 3
    End point values
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Number of subjects analysed
    3796
    1908
    Units: days
        median (full range (min-max))
    3 (1 to 110)
    3 (1 to 136)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were recorded from Vaccination 1 to 1 month after the last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
    Adverse event reporting additional description
    SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Group 1: rLP2086
    Reporting group description
    		 Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule

    Reporting group title
    Group 2: HAV/Saline/HAV
    Reporting group description
    		 Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month

    Serious adverse events
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    59 / 3796 (1.55%)
    48 / 1908 (2.52%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    CNS germinoma
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    2 / 3796 (0.05%)
    3 / 1908 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion missed
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 3796 (0.00%)
    2 / 1908 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular torsion
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 3796 (0.08%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperventilation
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    3 / 3796 (0.08%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 3796 (0.00%)
    3 / 1908 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 3796 (0.03%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    2 / 3796 (0.05%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Attention deficit or hyperactivity disorder
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizoaffective disorder
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 3796 (0.03%)
    2 / 1908 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    2 / 3796 (0.05%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cartilage injury
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat stroke
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Snake bite
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 3796 (0.03%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    1 / 3796 (0.03%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Demyelination
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningism
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular syndrome
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 3796 (0.00%)
    2 / 1908 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary dyskinesia
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Ingrowing nail
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal tubular necrosis
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperprolactinaemia
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothalamo-pituitary disorder
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    3 / 3796 (0.08%)
    4 / 1908 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 3796 (0.00%)
    3 / 1908 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    2 / 3796 (0.05%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    2 / 3796 (0.05%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 3796 (0.03%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis enterococcal
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis enteroviral
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salpingitis
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tick-borne viral encephalitis
         subjects affected / exposed
    1 / 3796 (0.03%)
    0 / 1908 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 3796 (0.00%)
    1 / 1908 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Group 1: rLP2086 Group 2: HAV/Saline/HAV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1671 / 3796 (44.02%)
    640 / 1908 (33.54%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    60 / 3796 (1.58%)
    30 / 1908 (1.57%)
         occurrences all number
    64
    32
    Contusion
         subjects affected / exposed
    50 / 3796 (1.32%)
    23 / 1908 (1.21%)
         occurrences all number
    54
    24
    Fall
         subjects affected / exposed
    38 / 3796 (1.00%)
    24 / 1908 (1.26%)
         occurrences all number
    39
    26
    Nervous system disorders
    Headache
         subjects affected / exposed
    249 / 3796 (6.56%)
    102 / 1908 (5.35%)
         occurrences all number
    296
    122
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    722 / 3796 (19.02%)
    149 / 1908 (7.81%)
         occurrences all number
    1007
    172
    Pyrexia
         subjects affected / exposed
    237 / 3796 (6.24%)
    44 / 1908 (2.31%)
         occurrences all number
    264
    44
    Injection site erythema
         subjects affected / exposed
    142 / 3796 (3.74%)
    6 / 1908 (0.31%)
         occurrences all number
    173
    6
    Vaccination site pain
         subjects affected / exposed
    126 / 3796 (3.32%)
    9 / 1908 (0.47%)
         occurrences all number
    173
    9
    Fatigue
         subjects affected / exposed
    82 / 3796 (2.16%)
    19 / 1908 (1.00%)
         occurrences all number
    89
    20
    Injection site swelling
         subjects affected / exposed
    84 / 3796 (2.21%)
    6 / 1908 (0.31%)
         occurrences all number
    100
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    89 / 3796 (2.34%)
    33 / 1908 (1.73%)
         occurrences all number
    100
    39
    Vomiting
         subjects affected / exposed
    60 / 3796 (1.58%)
    27 / 1908 (1.42%)
         occurrences all number
    65
    31
    Abdominal pain
         subjects affected / exposed
    47 / 3796 (1.24%)
    32 / 1908 (1.68%)
         occurrences all number
    49
    33
    Diarrhoea
         subjects affected / exposed
    42 / 3796 (1.11%)
    17 / 1908 (0.89%)
         occurrences all number
    43
    18
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    83 / 3796 (2.19%)
    41 / 1908 (2.15%)
         occurrences all number
    104
    47
    Cough
         subjects affected / exposed
    73 / 3796 (1.92%)
    34 / 1908 (1.78%)
         occurrences all number
    77
    35
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    76 / 3796 (2.00%)
    26 / 1908 (1.36%)
         occurrences all number
    84
    27
    Back pain
         subjects affected / exposed
    49 / 3796 (1.29%)
    26 / 1908 (1.36%)
         occurrences all number
    52
    26
    Arthralgia
         subjects affected / exposed
    40 / 3796 (1.05%)
    27 / 1908 (1.42%)
         occurrences all number
    47
    28
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    157 / 3796 (4.14%)
    87 / 1908 (4.56%)
         occurrences all number
    188
    97
    Nasopharyngitis
         subjects affected / exposed
    149 / 3796 (3.93%)
    84 / 1908 (4.40%)
         occurrences all number
    170
    101
    Pharyngitis
         subjects affected / exposed
    75 / 3796 (1.98%)
    47 / 1908 (2.46%)
         occurrences all number
    80
    49
    Gastroenteritis
         subjects affected / exposed
    64 / 3796 (1.69%)
    38 / 1908 (1.99%)
         occurrences all number
    68
    42
    Bronchitis
         subjects affected / exposed
    65 / 3796 (1.71%)
    36 / 1908 (1.89%)
         occurrences all number
    66
    39
    Sinusitis
         subjects affected / exposed
    54 / 3796 (1.42%)
    33 / 1908 (1.73%)
         occurrences all number
    58
    34
    Urinary tract infection
         subjects affected / exposed
    50 / 3796 (1.32%)
    24 / 1908 (1.26%)
         occurrences all number
    55
    34
    Pharyngitis streptococcal
         subjects affected / exposed
    45 / 3796 (1.19%)
    22 / 1908 (1.15%)
         occurrences all number
    50
    25
    Tonsillitis
         subjects affected / exposed
    38 / 3796 (1.00%)
    21 / 1908 (1.10%)
         occurrences all number
    41
    22
    Viral pharyngitis
         subjects affected / exposed
    41 / 3796 (1.08%)
    13 / 1908 (0.68%)
         occurrences all number
    59
    19

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2012
    Age range was changed to included subjects of 10 years; Subject withdrawal guidelines were clarified; AE reporting section was updated; Primary and secondary objectives and endpoints were revised to describe specific safety-related outcome measures; An exclusion criterion regarding subjects who were scheduled to receive human papilloma virus (HPV) vaccination as part of a series was added; Permitted treatment was revised to make non study vaccine prohibition consistent with other protocols; Definition of medically attended AE and newly diagnosed chronic medical condition were added.

    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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