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    Clinical Trial Results:
    A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE-BLIND TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF REPEVAX AND BIVALENT rLP2086 VACCINE WHEN ADMINISTERED CONCOMITANTLY IN HEALTHY SUBJECTS AGED ≥11 TO <19 YEARS

    Summary
    EudraCT number
    		 2010-022449-38
    Trial protocol
    		 DE   FI  
    Global end of trial date
    19 Feb 2013

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B1971010 (6108A1-2008)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01323270
    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 Center, Pfizer Inc, +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc, +1 8007181021, ClinicalTrials.gov_Inquiries@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
    06 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immune response induced by Repevax given with the bivalent rLP2086 vaccine (group 1) is non-inferior to the immune response induced by Repevax alone (group 2) when measured 1 month after vaccination 1. The immune responses to all components of Repevax will be assessed.
    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
    		 -
    Actual start date of recruitment
    18 Mar 2011
    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
    Finland: 377
    Country: Number of subjects enrolled
    Germany: 155
    Country: Number of subjects enrolled
    Poland: 220
    Worldwide total number of subjects
    752
    EEA total number of subjects
    752
    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)
    147
    Adolescents (12-17 years)
    482
    Adults (18-64 years)
    123
    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 753 subjects were enrolled in this study. Of these, 4 subjects were not randomized but were vaccinated rLP2086 vaccine or Repevax or Saline at Vaccination 1. These subjects were included in safety population and not intent-to-treat population.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: rLP2086 + Repevax
    Arm description
    		 Randomized to receive rLP2086 at 0-, 2-, 6-month and Repevax at 0-month.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bivalent rLP2086
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    rLP2086 was administered at 0-, 2-, 6-month.

    Investigational medicinal product name
    Repevax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Repevax was administered at 0 month.

    Arm title
    		 Group 2: Saline+Repevax
    Arm description
    		 Randomized to receive saline at 0-, 2-, 6-month and Repevax at 0-month.
    Arm type
    		 Control

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Saline was administered at 0-, 2-, 6- month.

    Investigational medicinal product name
    Repevax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Repevax was administered at 0-month.

    Number of subjects in period 1 [1]
    		Group 1: rLP2086 + Repevax Group 2: Saline+Repevax
    Started
    373
    376
    Completed
    330
    347
    Not completed
    43
    29
         Consent withdrawn by subject
    19
    10
         Physician decision
    -
    2
         Not eligible
    1
    1
         Death
    1
    -
         Randomized but not vaccinated
    1
    -
         Adverse event
    8
    -
         Lost to follow-up
    4
    6
         unspecified
    -
    3
         Protocol deviation
    9
    7
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 4 Subjects were not randomized but were vaccinated rLP2086 vaccine or repevax or saline at Vaccination 1. These subjects were included in safety population and not intent-to-treat population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: rLP2086 + Repevax
    Reporting group description
    		 Randomized to receive rLP2086 at 0-, 2-, 6-month and Repevax at 0-month.

    Reporting group title
    Group 2: Saline+Repevax
    Reporting group description
    		 Randomized to receive saline at 0-, 2-, 6-month and Repevax at 0-month.

    Reporting group values
    		 Group 1: rLP2086 + Repevax Group 2: Saline+Repevax Total
    Number of subjects
    		 373 376 749
    Age categorical
    Units: Subjects
        greater than or equal (>=)11- less than(<)14 years
    		 217 215 432
        >=14-<19 years
    		 156 161 317
    Gender categorical
    Units: Subjects
        Female
    		 183 184 367
        Male
    		 190 192 382

    End points

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    End points reporting groups
    Reporting group title
    Group 1: rLP2086 + Repevax
    Reporting group description
    		 Randomized to receive rLP2086 at 0-, 2-, 6-month and Repevax at 0-month.

    Reporting group title
    Group 2: Saline+Repevax
    Reporting group description
    		 Randomized to receive saline at 0-, 2-, 6-month and Repevax at 0-month.

    Subject analysis set title
    Group 1: rLP2086 + Repevax
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population

    Subject analysis set title
    Group 2: Saline+Repevax
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    safety population

    Primary: Percentage of Subjects Achieving Prespecified Criteria for the Concomitant Antigen

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    End point title
    		 Percentage of Subjects Achieving Prespecified Criteria for the Concomitant Antigen
    End point description
    End point type
    Primary
    End point timeframe
    1 month after Vaccination 1
    End point values
    		 Group 1: rLP2086 + Repevax Group 2: Saline+Repevax
    Number of subjects analysed
    337
    348
    Units: percentage of subjects
    number (not applicable)
        Diphtheria
    99.4
    99.4
        Tetanus
    100
    100
        Pertussis toxoid
    94.7
    96
        Pertussis filamentous hemagglutinin
    100
    100
        Pertussis pertactin
    100
    100
        Pertussis fimbrial agglutinogens types 2+3
    97.6
    98.9
        Poliovirus type 1
    100
    100
        Poliovirus type 2
    100
    100
        Poliovirus type 3
    100
    100
    Statistical analysis title
    		 Diphtheria
    Statistical analysis description
    Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.
    Comparison groups
    Group 1: rLP2086 + Repevax v Group 2: Saline+Repevax
    Number of subjects included in analysis
    685
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 percent difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 1.5
    Notes
    [1] - The non-inferiority criteria margin was 10%.
    Statistical analysis title
    		 Tetanus
    Statistical analysis description
    Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.
    Comparison groups
    Group 1: rLP2086 + Repevax v Group 2: Saline+Repevax
    Number of subjects included in analysis
    685
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 percent difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.1
    Notes
    [2] - The non-inferiority criteria margin was 10%.
    Statistical analysis title
    		 Pertussis toxoid
    Statistical analysis description
    Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.
    Comparison groups
    Group 1: rLP2086 + Repevax v Group 2: Saline+Repevax
    Number of subjects included in analysis
    685
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 percent difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 1.9
    Notes
    [3] - The non-inferiority criteria margin was 10%.
    Statistical analysis title
    		 Pertussis filamentous hemagglutinin
    Statistical analysis description
    Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.
    Comparison groups
    Group 1: rLP2086 + Repevax v Group 2: Saline+Repevax
    Number of subjects included in analysis
    685
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 percent difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.1
    Notes
    [4] - The non-inferiority criteria margin was 10%.
    Statistical analysis title
    		 Pertussis pertactin
    Statistical analysis description
    Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.
    Comparison groups
    Group 1: rLP2086 + Repevax v Group 2: Saline+Repevax
    Number of subjects included in analysis
    685
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 percent difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.1
    Notes
    [5] - The non-inferiority criteria margin was 10%.
    Statistical analysis title
    		 Pertussis fimbrial agglutinogens types 2+3
    Statistical analysis description
    Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.
    Comparison groups
    Group 1: rLP2086 + Repevax v Group 2: Saline+Repevax
    Number of subjects included in analysis
    685
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 percent difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 0.8
    Notes
    [6] - The non-inferiority criteria margin was 10%.
    Statistical analysis title
    		 Poliovirus type 1
    Statistical analysis description
    Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.
    Comparison groups
    Group 1: rLP2086 + Repevax v Group 2: Saline+Repevax
    Number of subjects included in analysis
    685
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 percent difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.1
    Notes
    [7] - The non-inferiority criteria margin was 10%.
    Statistical analysis title
    		 Poliovirus type 2
    Statistical analysis description
    Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.
    Comparison groups
    Group 1: rLP2086 + Repevax v Group 2: Saline+Repevax
    Number of subjects included in analysis
    685
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 percent difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.1
    Notes
    [8] - The non-inferiority criteria margin was 10%.
    Statistical analysis title
    		 Poliovirus type 3
    Statistical analysis description
    Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.
    Comparison groups
    Group 1: rLP2086 + Repevax v Group 2: Saline+Repevax
    Number of subjects included in analysis
    685
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 percent difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.1
    Notes
    [9] - The non-inferiority criteria margin was 10%.

    Primary: Percentage of Subjects With at Least One Adverse Event (AE)

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    End point title
    		 Percentage of Subjects With at Least One Adverse Event (AE) [10]
    End point description
    Summary was performed for subjects as per vaccine administration.
    End point type
    Primary
    End point timeframe
    Vaccination 1 up to 1 month after Vaccination 3
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1: rLP2086 + Repevax Group 2: Saline+Repevax
    Number of subjects analysed
    374
    378
    Units: percentage of subjects
        number (not applicable)
    37.4
    40.2
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens

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    End point title
    		 Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens
    End point description
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 1
    End point values
    		 Group 1: rLP2086 + Repevax Group 2: Saline+Repevax
    Number of subjects analysed
    337
    348
    Units: International units per milliliter
    geometric mean (confidence interval 95%)
        Diphtheria
    1.4 (1.28 to 1.55)
    1.5 (1.34 to 1.63)
        Tetanus
    12.3 (11.5 to 13.11)
    12.4 (11.52 to 13.25)
    No statistical analyses for this end point

    Secondary: GMC for Acellular Pertussis Antigens

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    End point title
    		 GMC for Acellular Pertussis Antigens
    End point description
    Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 1
    End point values
    		 Group 1: rLP2086 + Repevax Group 2: Saline+Repevax
    Number of subjects analysed
    337
    348
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Pertussis toxoid
    27.1 (24.45 to 30.07)
    26.5 (23.95 to 29.38)
        Pertussis filamentous hemagglutinin
    119.4 (111.15 to 128.17)
    122.9 (115.14 to 131.13)
        Pertussis pertactin
    317 (285.64 to 351.8)
    336.1 (305.82 to 369.3)
        Pertussis fimbrial agglutinogens types 2+3
    339.1 (296.35 to 387.94)
    364.5 (320.62 to 414.42)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer (GMT) for Poliomyelitis Antigens

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    End point title
    		 Geometric Mean Titer (GMT) for Poliomyelitis Antigens
    End point description
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 1
    End point values
    		 Group 1: rLP2086 + Repevax Group 2: Saline+Repevax
    Number of subjects analysed
    337
    348
    Units: titer
    geometric mean (confidence interval 95%)
        Poliovirus type 1
    662.1 (567.36 to 772.67)
    672.6 (581.87 to 777.55)
        Poliovirus type 2
    840.5 (725.11 to 974.29)
    995.8 (860.54 to 1152.41)
        Poliovirus type 3
    2237.4 (1945.81 to 2572.65)
    2450.1 (2152.6 to 2788.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level

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    End point title
    		 Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level
    End point description
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 3
    End point values
    		 Group 1: rLP2086 + Repevax Group 2: Saline+Repevax
    Number of subjects analysed
    307
    330
    Units: percentage of subjects
    number (not applicable)
        PMB80 [A22] 1:16 (N=158, 166)
    95.6
    19.9
        PMB2001 [A56] 1:8 (N=148, 152)
    100
    26.3
        PMB2948 [B24] 1:8 (N=157, 170)
    96.8
    12.9
        PMB2707 [B44] 1:8 (N=146, 159)
    81.5
    8.2
    No statistical analyses for this end point

    Other pre-specified: Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT)

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    End point title
    		 Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT)
    End point description
    hSBA Neisseria meningitidis serogroup B (MnB) immunogenicity assay results were disclosed instead of the IgG assay originally planned.
    End point type
    Other pre-specified
    End point timeframe
    Before vaccination 1, 1 month after Vaccination 2, 3
    End point values
    		 Group 1: rLP2086 + Repevax Group 2: Saline+Repevax
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: titer
        geometric mean (standard deviation)
    ( )
    ( )
    Notes
    [11] - hSBA MnB immunogenicity assay results were disclosed instead of the IgG assay originally planned.
    [12] - hSBA MnB immunogenicity assay results were disclosed instead of the IgG assay originally planned.
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Fold-Rise (GMFR) for IgG

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    End point title
    		 Geometric Mean Fold-Rise (GMFR) for IgG
    End point description
    hSBA MnB immunogenicity assay results were disclosed instead of the IgG assay originally planned.
    End point type
    Other pre-specified
    End point timeframe
    Before Vaccination 1, 1 month after Vaccination 2, 3
    End point values
    		 Group 1: rLP2086 + Repevax Group 2: Saline+Repevax
    Number of subjects analysed
    0 [13]
    0 [14]
    Units: fold rise
    Notes
    [13] - hSBA MnB immunogenicity assay results were disclosed instead of the IgG assay originally planned.
    [14] - hSBA MnB immunogenicity assay results were disclosed instead of the IgG assay originally planned.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE: Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax).Serious adverse event (SAE) reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax)
    Adverse event reporting additional description
    Events collected on case report form were reported. Summary was performed for subjects as per vaccine administration.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Group 1: rLP2086 + Repevax
    Reporting group description
    		 Randomized to receive rLP2086 at 0,-2,-6-month and Repevax at 0-month.

    Reporting group title
    Group 2: Saline+Repevax
    Reporting group description
    		 Randomized to receive saline at 0,-2,-6-month and Repevax at 0-month.

    Serious adverse events
    		 Group 1: rLP2086 + Repevax Group 2: Saline+Repevax
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 374 (3.21%)
    9 / 378 (2.38%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Congenital, familial and genetic disorders
    Syndactyly
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 378 (0.26%)
         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
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (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
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 378 (0.26%)
         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
    Dyspnoea
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 374 (0.27%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 378 (0.26%)
         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
    1 / 374 (0.27%)
    2 / 378 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (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 / 374 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 378 (0.26%)
         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 + Repevax Group 2: Saline+Repevax
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    98 / 374 (26.20%)
    118 / 378 (31.22%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    4 / 374 (1.07%)
    3 / 378 (0.79%)
         occurrences all number
    5
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 374 (2.41%)
    9 / 378 (2.38%)
         occurrences all number
    10
    11
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 374 (1.34%)
    4 / 378 (1.06%)
         occurrences all number
    5
    4
    Injection site pain
         subjects affected / exposed
    4 / 374 (1.07%)
    0 / 378 (0.00%)
         occurrences all number
    6
    0
    Injection site swelling
         subjects affected / exposed
    4 / 374 (1.07%)
    0 / 378 (0.00%)
         occurrences all number
    4
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    4 / 374 (1.07%)
    3 / 378 (0.79%)
         occurrences all number
    5
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 374 (1.07%)
    3 / 378 (0.79%)
         occurrences all number
    4
    3
    Nausea
         subjects affected / exposed
    1 / 374 (0.27%)
    4 / 378 (1.06%)
         occurrences all number
    1
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 374 (0.53%)
    6 / 378 (1.59%)
         occurrences all number
    2
    6
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 374 (1.60%)
    7 / 378 (1.85%)
         occurrences all number
    6
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    30 / 374 (8.02%)
    31 / 378 (8.20%)
         occurrences all number
    37
    36
    Pharyngitis
         subjects affected / exposed
    17 / 374 (4.55%)
    19 / 378 (5.03%)
         occurrences all number
    18
    23
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 374 (4.28%)
    19 / 378 (5.03%)
         occurrences all number
    20
    19
    Bronchitis
         subjects affected / exposed
    9 / 374 (2.41%)
    18 / 378 (4.76%)
         occurrences all number
    9
    20
    Gastroenteritis
         subjects affected / exposed
    8 / 374 (2.14%)
    11 / 378 (2.91%)
         occurrences all number
    8
    12
    Sinusitis
         subjects affected / exposed
    8 / 374 (2.14%)
    6 / 378 (1.59%)
         occurrences all number
    9
    6
    Otitis media
         subjects affected / exposed
    3 / 374 (0.80%)
    7 / 378 (1.85%)
         occurrences all number
    3
    7
    Acute tonsillitis
         subjects affected / exposed
    1 / 374 (0.27%)
    7 / 378 (1.85%)
         occurrences all number
    1
    8
    Tonsillitis
         subjects affected / exposed
    1 / 374 (0.27%)
    7 / 378 (1.85%)
         occurrences all number
    2
    8
    Rhinitis
         subjects affected / exposed
    2 / 374 (0.53%)
    4 / 378 (1.06%)
         occurrences all number
    2
    4

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jul 2011
    1) Subject participation in the study was increased from 14 to 17 months. 2) Duration of the study was increased from 17 to 20 months.
    18 Apr 2012
    1) Any non-serious AE that was determined by the sponsor to be serious was reported as an SAE. To assist in the determination of case seriousness further information was being requested from the investigator to provide clarity and understanding of the event in the context of the trial. 2) Active reporting period and necessity to report all SAEs post-active reporting period was specified as follows-A subject’s AE (serious and non serious) was reported and recorded from the signing of the Informed consent form (ICF) to visit 6 (postvaccination 3 blood draw) and at month 12 (Final Telephone Contact), the parent/legal guardian or subject was to be contacted by telephone to inquire about SAEs including hospitalizations, and newly diagnosed major illnesses or conditions since visit 6. 3) Exposure during pregnancy was updated as- A female becomes, or is found to be, pregnant either while receiving or being exposed (eg, due to treatment or environmental exposure) or after discontinuing or having been directly exposed to the investigational product. 4)In the case of a live birth, the structural integrity of the neonate was assessed by gross visual inspection (unless pre-procedure test findings were conclusive for a congenital anomaly and the findings are reported).In case of termination, the reason(s) for the termination was to be specified. 5) Clarification added regarding persistent or significant disability/ incapacity (SAE) as substantial disruption of the ability to conduct normal life functions. 6) Definition of AE updated to include drug abuse and drug dependency factor along with signs and symptoms resulting from exposure via breastfeeding and medication error. 7) Definition for Medication errors was updated to provide clarity.
    13 Dec 2012
    1) Safety endpoint was updated to in consistent to Phase 3 program with definite window (time-frame) of assessment of proportion of subjects reporting local reactions, systemic reactions , SAE and AE.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Jul 2011
    Study injections for this study were temporarily paused on during investigation of a suspected, unexpected, serious adverse reaction (SUSAR) identified after hospitalization of the subject. The subject experienced severe chills, headache and vertigo approximately 70 minutes after receiving the second dose of rLP2086 vaccine in study B1971012.
    01 Nov 2011

    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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