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    Clinical Trial Results:
    A phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female subjects aged 9-17 years.

    Summary
    EudraCT number
    		 2012-003025-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Dec 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Mar 2023
    First version publication date
    12 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    112022
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Mar 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To demonstrate the non-inferiority of HPV immune response at one month post-dose 3 in Chinese female subjects aged 9-17 years from the current study versus Chinese women aged 18-25 years enrolled in the HPV-039 study (eTrack No. 107638). Criteria for non-inferiority (one month after the third vaccine dose): -The objective will be reached if for each HPV antigen (anti-HPV-16 and anti-HPV-18), the upper limit of the 95% confidence interval (CI) for the GMT ratio [GMTs in subjects aged 18-25 years with immunogenicity results at Month 7 who receive HPV-16/18 L1 VLP AS04 vaccine in the HPV-039 study divided by the GMTs of subjects aged 9-17 years who receive HPV-16/18 L1 VLP AS04 vaccine in the HPV-058 study] is below 2. -This objective will be evaluated in the according-to-protocol (ATP) cohort for immunogenicity
    Protection of trial subjects
    As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccine remained under medical supervision for 30 minutes after vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Oct 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 750
    Worldwide total number of subjects
    750
    EEA total number of subjects
    0
    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)
    0
    Adolescents (12-17 years)
    750
    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
    		 -

    Pre-assignment
    Screening details
    		 A total number of 750 subjects were enrolled in this study.

    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, Monitor
    Blinding implementation details
    Blinding was maintained for all subjects and investigators and their study staff participating in this study with regard to the individual subject treatment (vaccine or control) assignments allocated in this study. GSK personnel directly involved in the conduct of this study (e.g. site monitors, medical monitors, laboratory personnel, etc.) was also blinded to the subject’s treatment assignments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cervarix Group
    Arm description
    		 Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received three doses of the Cervarix vaccine intramuscularly according to a 0, 1, 6-month schedule.

    Arm title
    		 Placebo Group
    Arm description
    		 Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
    Arm type
    		 Control

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received three doses of control intramuscularly according to a 0, 1, 6-month schedule.

    Number of subjects in period 1
    		Cervarix Group Placebo Group
    Started
    374
    376
    Completed
    369
    365
    Not completed
    5
    11
         Consent withdrawn by subject
    4
    3
         Adverse event, non-fatal
    -
    2
         Lost to follow-up
    1
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.

    Reporting group values
    		 Cervarix Group Placebo Group Total
    Number of subjects
    		 374 376 750
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.1 ± 2.44 13.1 ± 2.42 -
    Gender categorical
    Units: Subjects
        Female
    		 374 376 750
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.

    Primary: Geometric mean titers (GMTs) for antibodies against Human Papillomavirus (HPV)-16/18 antigens

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    End point title
    		 Geometric mean titers (GMTs) for antibodies against Human Papillomavirus (HPV)-16/18 antigens
    End point description
    Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
    End point type
    Primary
    End point timeframe
    One month after the third dose (at Month 7)
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    362
    363
    Units: titers
    geometric mean (confidence interval 95%)
        Anti-HPV-16
    18347.1 (16915.2 to 19900.2)
    5 (4.7 to 5.3)
        Anti-HPV-18
    7960.2 (7181.3 to 8823.6)
    4.1 (3.8 to 4.3)
    Statistical analysis title
    		 Anti-HPV-016 immune response
    Comparison groups
    Cervarix Group v Placebo Group
    Number of subjects included in analysis
    725
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 2
    Method
    		 t-test, 2-sided
    Parameter type
    		 GMT ratio
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 0.43
    Variability estimate
    Standard deviation
    Dispersion value
    0.37
    Statistical analysis title
    		 Anti-HPV-018 immune response
    Comparison groups
    Cervarix Group v Placebo Group
    Number of subjects included in analysis
    725
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 2
    Method
    		 GMT ratio
    Parameter type
    		 GMT ratio
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.49
    Variability estimate
    Standard deviation
    Dispersion value
    0.42

    Secondary: Number of subjects seroconverted for Anti-HPV-16 and Anti-HPV-18 antibodies

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    End point title
    		 Number of subjects seroconverted for Anti-HPV-16 and Anti-HPV-18 antibodies
    End point description
    Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.
    End point type
    Secondary
    End point timeframe
    At Month 7
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    338
    344
    Units: Subjects
        Anti-HPV-16 (N=326;323)
    326
    8
        Anti-HPV-18 (N=338;344)
    336
    10
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptoms
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
    End point type
    Secondary
    End point timeframe
    During the 7 days (Days 0 – 6) following each vaccination
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    373
    376
    Units: Subjects
        Any pain
    350
    299
        Grade 3 pain
    38
    16
        Any redness
    113
    52
        Grade 3 redness
    2
    1
        Any swelling
    113
    54
        Grade 3 swelling
    13
    2
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms
    End point description
    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 7 days (Days 0 – 6) following each vaccination
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    373
    376
    Units: Subjects
        Any arthralgia
    38
    33
        Grade 3 arthralgia
    0
    2
        Related arthralgia
    25
    23
        Any fatigue
    137
    126
        Grade 3 fatigue
    2
    4
        Related fatigue
    106
    98
        Any gastrointestinal symptoms
    57
    45
        Grade 3 gastrointestinal symptoms
    2
    2
        Related gastrointestinal symptoms
    21
    31
        Any headache
    123
    99
        Grade 3 headache
    5
    3
        Related headache
    80
    70
        Any myalgia
    110
    93
        Grade 3 myalgia
    1
    1
        Related myalgia
    96
    83
        Any rash
    9
    4
        Grade 3 rash
    0
    0
        Related rash
    3
    2
        Any fever
    86
    74
        Grade 3 fever
    2
    0
        Related fever
    40
    27
        Any urticaria
    8
    3
        Grade 3 urticaria
    0
    0
        Related urticaria
    7
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting medically significant conditions (MSCs)

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    End point title
    		 Number of subjects reporting medically significant conditions (MSCs)
    End point description
    Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. MSCs were collected regardless of causal relationship to vaccination and intensity.
    End point type
    Secondary
    End point timeframe
    Throughout the study period (from Day 0 up to Month 12)
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    374
    376
    Units: Subjects
        Any MSC(s)
    14
    11
    No statistical analyses for this end point

    Secondary: Number of subjects reporting pregnancies and pregnancy outcomes

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    End point title
    		 Number of subjects reporting pregnancies and pregnancy outcomes
    End point description
    End point type
    Secondary
    End point timeframe
    Throughout the study period (from Day 0 up to Month 12)
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    374
    376
    Units: Subjects
        Pregnancies
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs)
    End point description
    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 30 days (Days 0 – 29) after any vaccination
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    374
    376
    Units: Subjects
        Any AEs
    139
    125
        Grade 3 AEs
    0
    3
        Related AEs
    2
    3
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any and related serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Throughout the study period (from Day 0 up to Month 12)
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    374
    376
    Units: Subjects
        Any SAEs
    5
    2
        Related SAEs
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively.
    Adverse event reporting additional description
    For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.

    Serious adverse events
    		 Cervarix Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 374 (1.34%)
    2 / 376 (0.53%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 376 (0.27%)
         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
    Lymphadenopathy
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 376 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 376 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 376 (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
    Adnexa uteri cyst
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 376 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 376 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cervarix Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    360 / 374 (96.26%)
    339 / 376 (90.16%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    350 / 373 (93.83%)
    299 / 376 (79.52%)
         occurrences all number
    350
    299
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    113 / 373 (30.29%)
    52 / 376 (13.83%)
         occurrences all number
    113
    52
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    113 / 373 (30.29%)
    54 / 376 (14.36%)
         occurrences all number
    113
    54
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    38 / 373 (10.19%)
    33 / 376 (8.78%)
         occurrences all number
    38
    33
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    137 / 373 (36.73%)
    126 / 376 (33.51%)
         occurrences all number
    137
    126
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    57 / 373 (15.28%)
    45 / 376 (11.97%)
         occurrences all number
    57
    45
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    123 / 373 (32.98%)
    99 / 376 (26.33%)
         occurrences all number
    123
    99
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    110 / 373 (29.49%)
    93 / 376 (24.73%)
         occurrences all number
    110
    93
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    86 / 373 (23.06%)
    74 / 376 (19.68%)
         occurrences all number
    86
    74
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    101 / 374 (27.01%)
    86 / 376 (22.87%)
         occurrences all number
    101
    86
    Nasopharyngitis
         subjects affected / exposed
    22 / 374 (5.88%)
    18 / 376 (4.79%)
         occurrences all number
    22
    18
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject cohort and the analysis of a given measurement, missing or non-evaluable measurements were not replaced. Therefore, an analysis excluded data points for subjects with missing or non-evaluable measurements i.e. analysis of solicited symptoms excluded vaccinated subjects without documented Diary Cards.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject cohort and the analysis of a given measurement, missing or non-evaluable measurements were not replaced. Therefore, an analysis excluded data points for subjects with missing or non-evaluable measurements i.e. analysis of solicited symptoms excluded vaccinated subjects without documented Diary Cards.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject cohort and the analysis of a given measurement, missing or non-evaluable measurements were not replaced. Therefore, an analysis excluded data points for subjects with missing or non-evaluable measurements i.e. analysis of solicited symptoms excluded vaccinated subjects without documented Diary Cards.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject cohort and the analysis of a given measurement, missing or non-evaluable measurements were not replaced. Therefore, an analysis excluded data points for subjects with missing or non-evaluable measurements i.e. analysis of solicited symptoms excluded vaccinated subjects without documented Diary Cards.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject cohort and the analysis of a given measurement, missing or non-evaluable measurements were not replaced. Therefore, an analysis excluded data points for subjects with missing or non-evaluable measurements i.e. analysis of solicited symptoms excluded vaccinated subjects without documented Diary Cards.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject cohort and the analysis of a given measurement, missing or non-evaluable measurements were not replaced. Therefore, an analysis excluded data points for subjects with missing or non-evaluable measurements i.e. analysis of solicited symptoms excluded vaccinated subjects without documented Diary Cards.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject cohort and the analysis of a given measurement, missing or non-evaluable measurements were not replaced. Therefore, an analysis excluded data points for subjects with missing or non-evaluable measurements i.e. analysis of solicited symptoms excluded vaccinated subjects without documented Diary Cards.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject cohort and the analysis of a given measurement, missing or non-evaluable measurements were not replaced. Therefore, an analysis excluded data points for subjects with missing or non-evaluable measurements i.e. analysis of solicited symptoms excluded vaccinated subjects without documented Diary Cards.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject cohort and the analysis of a given measurement, missing or non-evaluable measurements were not replaced. Therefore, an analysis excluded data points for subjects with missing or non-evaluable measurements i.e. analysis of solicited symptoms excluded vaccinated subjects without documented Diary Cards.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Nov 2010
    Amendment 1 • Due to a delay in the availability of the Month 7 serology data to be generated at the National Institute for Control of Pharmaceutical and Biological Products (NICPBP), the initial planned final analysis (for immunogenicity and safety data up to Month 7) and the annex analysis (for safety data collected during the 5-month extended safety follow-up (EFSU) period up to Month 12) will be conducted as one final analysis and will include all data up to Month 12. A clinical study report will be written to present the final analysis data. • The name of the coordinating authors and contributing authors have been updated in the title page.

    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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