Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase IIIb, double-blind, randomized, controlled, multicentre study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 months) in healthy female subjects aged 10-25 years.

    Summary
    EudraCT number
    		 2017-000416-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jul 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Feb 2018
    First version publication date
    14 Feb 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    106069
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00481767
    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
    30 Nov 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To evaluate antibody responses enzyme-linked immunosorbent assay (ELISA) against HPV-16 and HPV-18 at Month 7 in subjects 15 - 25 years of age. •To evaluate the antibody responses against HPV-16 and HPV-18 at Month 7 in subjects 10 - 14 years of age.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of vaccines, with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Senegal: 342
    Country: Number of subjects enrolled
    Tanzania, United Republic of: 334
    Worldwide total number of subjects
    676
    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)
    232
    Adolescents (12-17 years)
    222
    Adults (18-64 years)
    222
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 At the screening visits, subjects were interviewed on their previous medical history (including smoking history, sexual and reproductive history and contraceptive status) and underwent general physical examination and pregnancy test.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cervarix Group
    Arm description
    		 Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline Biologicals' HPV vaccine GSK580299; HPV-16/18 L1 AS04 vaccine
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses of vaccine (0.5 mL) were administered intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.

    Arm title
    		 Placebo Group
    Arm description
    		 Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Al(OH)3
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses of Placebo (0.5 mL) were administered intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.

    Number of subjects in period 1
    		Cervarix Group Placebo Group
    Started
    450
    226
    Completed
    418
    205
    Not completed
    32
    21
         Consent withdrawn by subject
    16
    11
         Lost to follow-up
    16
    10

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.

    Reporting group values
    		 Cervarix Group Placebo Group Total
    Number of subjects
    		 450 226
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 16.9 ( 4.36 ) 16.8 ( 4.16 ) -
    Gender categorical
    Units: Subjects
        Female
    		 450 226 676
        Male
    		 0 0 0
    Race/ethnicity
    Units: Subjects
        African/African american
    		 431 219 650
        Not specified
    		 19 7 26

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.

    Primary: Number of seroconverted subjects for anti-human papillomavirus (HPV)-16 and 18 antibodies

    		 Close Top of page
    End point title
    		 Number of seroconverted subjects for anti-human papillomavirus (HPV)-16 and 18 antibodies [1]
    End point description
    A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
    End point type
    Primary
    End point timeframe
    At Month 7
    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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    212
    98
    Units: Subjects
        10-14 years anti-HPV-16 (N=130;59)
    130
    4
        15-25 years anti-HPV-16 (N=190;97)
    190
    5
        10-14 years anti-HPV-18 (N=128;56)
    128
    2
        15-25 years anti-HPV-18 (N=212;98)
    212
    5
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of anti-HPV-16 and anti-HPV-18 antibodies

    		 Close Top of page
    End point title
    		 Geometric Mean Titers (GMTs) of anti-HPV-16 and anti-HPV-18 antibodies [2]
    End point description
    Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
    End point type
    Primary
    End point timeframe
    At Month 7
    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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    237
    114
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        10-14 years anti-HPV-16 (N=142;65)
    18591.3 (16433.0 to 21033.1)
    4.8 (4.2 to 5.5)
        15-25 years anti-HPV-16 (N=237;112)
    10664.0 (9668.5 to 11762.0)
    5.3 (4.6 to 6.1)
        10-14 years anti-HPV-18 (N=141;66)
    6409.8 (5563.4 to 7385.0)
    3.9 (3.6 to 4.2)
        15-25 years anti-HPV-18 (N=235;114)
    3653.6 (3343.9 to 3991.9)
    4.6 (4.0 to 5.3)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of seroconverted subjects for anti-HPV-16 and anti-HPV-18 antibodies
    End point description
    A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 12
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    212
    98
    Units: Subjects
        10-14 years anti-HPV-16 Month 2 (N=130;59)
    130
    1
        15-25 years anti-HPV-16 Month 2 (N=190;96)
    190
    3
        10-14 years anti-HPV-16 Month 12 (N=128;59)
    128
    2
        15-25 years anti-HPV-16 Month 12 (N=184;94)
    184
    7
        10-14 years anti-HPV-18 Month 2 (N=128;55)
    128
    1
        15-25 years anti-HPV-18 Month 2 (N=212;98)
    212
    4
        10-14 years anti-HPV-18 Month 12 (N=126;56)
    125
    0
        15-25 years anti-HPV-18 Month 12 (N=205;96)
    205
    6
    No statistical analyses for this end point

    Secondary: GMTs for anti-HPV-16 and anti-HPV-18 antibodies

    		 Close Top of page
    End point title
    		 GMTs for anti-HPV-16 and anti-HPV-18 antibodies
    End point description
    Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 12
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    237
    112
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        10-14 years anti-HPV-16 Month 2 (N=142;64)
    5340.2 (4823.7 to 5912.0)
    4.5 (4.0 to 5.0)
        15-25 years anti-HPV-16 Month 2 (N=237;112)
    3732.6 (3436.6 to 4054.1)
    4.9 (4.3 to 5.5)
        10-14 years anti-HPV-16 Month 12 (N=139;65)
    4016.2 (3323.3 to 4853.7)
    4.7 (4.2 to 5.3)
        15-25 years anti-HPV-16 Month 12 (N=229;109)
    2464.2 (2196.5 to 2764.5)
    5.6 (4.7 to 6.6)
        10-14 years anti-HPV-18 Month 2 (N=141;65)
    3016.7 (2677.4 to 3398.9)
    3.9 (3.6 to 4.3)
        15-25 years anti-HPV-18 Month 2 (N=235;112)
    2039.3 (1861.3 to 2234.4)
    4.6 (4.0 to 5.3)
        10-14 years anti-HPV-18 Month 12 (N=138;66)
    1422.1 (1170.0 to 1728.4)
    3.7 (3.5 to 3.9)
        15-25 years anti-HPV-18 Month 12 (N=227;111)
    855.9 (768.3 to 953.5)
    4.6 (4.0 to 5.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with any and Grade 3 solicited local symptoms

    		 Close Top of page
    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms
    End point description
    Solicited local symptoms assessed were pain and swelling at the injection site. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Grade 3 pain = pain that prevented normal activity.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 0-6) after each dose and across doses
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    450
    226
    Units: Subjects
        Any Pain, Dose 1 (N=450;226)
    309
    116
        Grade 3 Pain, Dose 1 (N=450;226)
    2
    0
        Any Swelling, Dose 1 (N=450;226)
    15
    7
        Grade 3 Swelling, Dose 1 (N=450;226)
    0
    0
        Any Pain, Dose 2 (N=437;217)
    265
    95
        Grade 3 Pain, Dose 2 (N=437;217)
    0
    0
        Any Swelling, Dose 2 (N=437;217)
    45
    15
        Grade 3 Swelling, Dose 2 (N=437;217)
    0
    0
        Any Pain, Dose 3 (N=411;200)
    200
    66
        Grade 3 Pain, Dose 3 (N=411;200)
    0
    0
        Any Swelling, Dose 3 (N=411;200)
    26
    10
        Grade 3 Swelling, Dose 3 (N=411;200)
    0
    0
        Any Pain, Across doses (N=450;226)
    375
    166
        Grade 3 Pain, Across doses (N=450;226)
    2
    0
        Any Swelling, Across doses (N=450;226)
    74
    27
        Grade 3 Swelling, Across doses (N=450;226)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any, Grade 3 and related solicited general symptoms

    		 Close Top of page
    End point title
    		 Number of subjects with any, Grade 3 and related solicited general symptoms
    End point description
    Solicited general symptoms assessed were arthralgia (only joints that are distal from the injection site), fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 0-6) after each dose and across doses
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    450
    226
    Units: Subjects
        Any Arthralgia, Dose 1 (N=450;226)
    19
    10
        Grade 3 Arthralgia, Dose 1 (N=450;226)
    0
    0
        Related Arthralgia, Dose 1 (N=450;226)
    7
    2
        Any Fatigue, Dose 1 (N=450;226)
    34
    12
        Grade 3 Fatigue, Dose 1 (N=450;226)
    0
    0
        Related Fatigue, Dose 1 (N=450;226)
    21
    3
        Any Fever, Dose 1 (N=450;226)
    72
    43
        Grade 3 Fever, Dose 1 (N=450;226)
    0
    0
        Related Fever, Dose 1 (N=450;226)
    34
    17
        Any Gastrointestinal, Dose 1 (N=450;226)
    34
    21
        Grade 3 Gastrointestinal, Dose 1 (N=450;226)
    0
    0
        Related Gastrointestinal, Dose 1 (N=450;226)
    14
    8
        Any Headache, Dose 1 (N=450;226)
    89
    56
        Grade 3 Headache, Dose 1 (N=450;226)
    0
    0
        Related Headache, Dose 1 (N=450;226)
    51
    25
        Any Myalgia, Dose 1 (N=450;226)
    35
    16
        Grade 3 Myalgia, Dose 1 (N=450;226)
    0
    0
        Related Myalgia, Dose 1 (N=450;226)
    22
    7
        Any Rash, Dose 1 (N=450;226)
    14
    8
        Grade 3 Rash, Dose 1 (N=450;226)
    0
    0
        Related Rash, Dose 1 (N=450;226)
    1
    0
        Any Urticaria, Dose 1 (N=450;226)
    12
    7
        Grade 3 Urticaria, Dose 1 (N=450;226)
    0
    0
        Related Urticaria, Dose 1 (N=450;226)
    0
    0
        Any Arthralgia, Dose 2 (N=437;217)
    47
    17
        Grade 3 Arthralgia, Dose 2 (N=437;217)
    0
    0
        Related Arthralgia, Dose 2 (N=437;217)
    4
    2
        Any Fatigue, Dose 2 (N=437;217)
    62
    25
        Grade 3 Fatigue, Dose 2 (N=437;217)
    0
    0
        Related Fatigue, Dose 2 (N=437;217)
    17
    4
        Any Fever, Dose 2 (N=437;217)
    82
    33
        Grade 3 Fever, Dose 2 (N=437;217)
    0
    0
        Related Fever, Dose 2 (N=437;217)
    19
    8
        Any Gastrointestinal, Dose 2 (N=437;217)
    66
    26
        Grade 3 Gastrointestinal, Dose 2 (N=437;217)
    0
    0
        Related Gastrointestinal, Dose 2 (N=437;217)
    15
    6
        Any Headache, Dose 2 (N=437;217)
    96
    49
        Grade 3 Headache, Dose 2 (N=437;217)
    0
    0
        Related Headache, Dose 2 (N=437;217)
    40
    18
        Any Myalgia, Dose 2 (N=437;217)
    50
    17
        Grade 3 Myalgia, Dose 2 (N=437;217)
    0
    0
        Related Myalgia, Dose 2 (N=437;217)
    9
    3
        Any Rash, Dose 2 (N=437;217)
    44
    15
        Grade 3 Rash, Dose 2 (N=437;217)
    0
    0
        Related Rash, Dose 2 (N=437;217)
    1
    0
        Any Urticaria, Dose 2 (N=437;217)
    43
    14
        Grade 3 Urticaria, Dose 2 (N=437;217)
    0
    0
        Related Urticaria, Dose 2 (N=437;217)
    0
    0
        Any Arthralgia, Dose 3 (N=411;200)
    28
    10
        Grade 3 Arthralgia, Dose 3 (N=411;200)
    0
    0
        Related Arthralgia, Dose 3 (N=411;200)
    0
    0
        Any Fatigue, Dose 3 (N=411;200)
    34
    13
        Grade 3 Fatigue, Dose 3 (N=411;200)
    0
    0
        Related Fatigue, Dose 3 (N=411;200)
    4
    3
        Any Fever, Dose 3 (N=411;200)
    81
    33
        Grade 3 Fever, Dose 3 (N=411;200)
    0
    0
        Related Fever, Dose 3 (N=411;200)
    20
    9
        Any Gastrointestinal, Dose 3 (N=411;200)
    43
    19
        Grade 3 Gastrointestinal, Dose 3 (N=411;200)
    0
    0
        Related Gastrointestinal, Dose 3 (N=411;200)
    5
    5
        Any Headache, Dose 3 (N=411;200)
    71
    33
        Grade 3 Headache, Dose 3 (N=411;200)
    0
    0
        Related Headache, Dose 3 (N=411;200)
    22
    12
        Any Myalgia, Dose 3 (N=411;200)
    28
    10
        Grade 3 Myalgia, Dose 3 (N=411;200)
    0
    0
        Related Myalgia, Dose 3 (N=411;200)
    1
    0
        Any Rash, Dose 3 (N=411;200)
    26
    12
        Grade 3 Rash, Dose 3 (N=411;200)
    0
    0
        Related Rash, Dose 3 (N=411;200)
    0
    0
        Any Urticaria, Dose 3 (N=411;200)
    26
    11
        Grade 3 Urticaria, Dose 3 (N=411;200)
    0
    0
        Related Urticaria, Dose 3 (N=411;200)
    0
    0
        Any Arthralgia, Across doses (N=450;226)
    77
    32
        Grade 3 Arthralgia, Across doses (N=450;226)
    0
    0
        Related Arthralgia, Across doses (N=450;226)
    10
    4
        Any Fatigue, Across doses (N=450;226)
    111
    42
        Grade 3 Fatigue, Across doses (N=450;226)
    0
    0
        Related Fatigue, Across doses (N=450;226)
    39
    9
        Any Fever, Across doses (N=450;226)
    147
    70
        Grade 3 Fever, Across doses (N=450;226)
    0
    0
        Related Fever, Across doses (N=450;226)
    57
    27
        Any Gastrointestinal, Across doses (N=450;226)
    118
    56
        Grade 3 Gastrointestinal, Across doses(N=450;226)
    0
    0
        Related Gastrointestinal, Across doses(N=450;226)
    31
    17
        Any Headache, Across doses (N=450;226)
    189
    109
        Grade 3 Headache, Across doses (N=450;226)
    0
    0
        Related Headache, Across doses (N=450;226)
    101
    46
        Any Myalgia, Across doses (N=450;226)
    90
    36
        Grade 3 Myalgia, Across doses (N=450;226)
    0
    0
        Related Myalgia, Across doses (N=450;226)
    27
    9
        Any Rash, Across doses (N=450;226)
    71
    30
        Grade 3 Rash, Across doses (N=450;226)
    0
    0
        Related Rash, Across doses (N=450;226)
    2
    0
        Any Urticaria, Across doses (N=450;226)
    68
    27
        Grade 3 Urticaria, Across doses (N=450;226)
    0
    0
        Related Urticaria, Across doses (N=450;226)
    0
    0
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 = any unsolicited AE regardless of intensity and relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 30 days (Day 0-29) after any vaccination
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    450
    226
    Units: Subjects
        Any AE(s)
    235
    142
        Grade 3 AE(s)
    5
    1
        Related AE(s)
    3
    4
    No statistical analyses for this end point

    Secondary: Number of subjects with new onset of chronic diseases (NOCDs) and medically significant conditions (MSCs)

    		 Close Top of page
    End point title
    		 Number of subjects with new onset of chronic diseases (NOCDs) and medically significant conditions (MSCs)
    End point description
    NOCDs assessed included autoimmune disorders, asthma, type I diabetes, allergies. MSCs assessed included AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 7 and from Month 7 up to Month 12
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    450
    226
    Units: Subjects
        NOCD(s) up to Month 7 (N=450;226)
    10
    8
        NOCD(s) Month 7-12 (N=421;208)
    1
    3
        MSC(s) up to Month 7 (N=450;226)
    289
    161
        MSC(s) Month 7-12 (N=421;208)
    121
    68
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

    		 Close Top of page
    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 7 and from Month 7 up to Month 12
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    450
    226
    Units: Subjects
        Up to Month 7
    12
    10
        Up to Month 12
    17
    14
    No statistical analyses for this end point

    Secondary: Number of subjects with pregnancies and their outcomes

    		 Close Top of page
    End point title
    		 Number of subjects with pregnancies and their outcomes
    End point description
    Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 12
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    14
    10
    Units: Subjects
        Ectopic pregnancy
    1
    0
        Elective termination
    3
    3
        Live infant
    5
    5
        Premature live infant
    3
    1
        Lost to follow-up
    1
    0
        Spontaneous abortion
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Senegalese subjects with clinically relevant abnormalities in parameters assessed

    		 Close Top of page
    End point title
    		 Number of Senegalese subjects with clinically relevant abnormalities in parameters assessed
    End point description
    Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
    End point type
    Secondary
    End point timeframe
    At Month 7
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    217
    105
    Units: Subjects
        ALT, pre-vacc. ABOVE (N=8;4), Month 7 NORMAL
    7
    4
        ALT, pre-vacc.ABOVE (N=8;4), Month 7 BELOW
    0
    0
        ALT, pre-vacc. ABOVE (N=8;4), Month 7 ABOVE
    1
    0
        ALT, pre-vacc. BELOW (N=39;17), Month 7 NORMAL
    15
    7
        ALT, pre-vacc. BELOW (N=39;17), Month 7 BELOW
    24
    10
        ALT, pre-vacc. BELOW (N=39;17), Month 7 ABOVE
    0
    0
        ALT, pre-vacc. NORMAL (N=170;84), Month 7 NORMAL
    137
    57
        ALT, pre-vacc. NORMAL (N=170;84), Month 7 BELOW
    30
    25
        ALT, pre-vacc. NORMAL (N=170;84), Month 7 ABOVE
    3
    2
        BAS, pre-vacc. NORMAL (N=217;105), Month 7 NORMAL
    216
    105
        BAS, pre-vacc. NORMAL (N=217;105), Month 7 BELOW
    0
    0
        BAS, pre-vacc. NORMAL (N=217;105), Month 7 ABOVE
    1
    0
        CREA, pre-vacc. ABOVE (N=2;1), Month 7 NORMAL
    1
    1
        CREA, pre-vacc. ABOVE (N=2;1), Month 7 BELOW
    0
    0
        CREA, pre-vacc. ABOVE (N=2;1), Month 7 ABOVE
    1
    0
        CREA, pre-vacc. BELOW (N=56;30), Month 7 NORMAL
    19
    13
        CREA, pre-vacc. BELOW (N=56;30), Month 7 BELOW
    37
    17
        CREA, pre-vacc. BELOW (N=56;30), Month 7 ABOVE
    0
    0
        CREA, pre-vacc. NORMAL (N=159;74), Month 7 NORMAL
    149
    68
        CREA, pre-vacc. NORMAL (N=159;74), Month 7 BELOW
    10
    4
        CREA, pre-vacc. NORMAL (N=159;74), Month 7 ABOVE
    0
    2
        EOS, pre-vacc. ABOVE (N=43;28), Month 7 NORMAL
    9
    12
        EOS, pre-vacc. ABOVE (N=43;28), Month 7 BELOW
    0
    0
        EOS, pre-vacc. ABOVE (N=43;28), Month 7 ABOVE
    34
    16
        EOS, pre-vacc. BELOW (N=19;10), Month 7 NORMAL
    17
    9
        EOS, pre-vacc. BELOW (N=19;10), Month 7 BELOW
    2
    1
        EOS, pre-vacc. BELOW (N=19;10), Month 7 ABOVE
    0
    0
        EOS, pre-vacc. NORMAL (N=155;67), Month 7 NORMAL
    134
    56
        EOS, pre-vacc. NORMAL (N=155;67), Month 7 BELOW
    3
    2
        EOS, pre-vacc. NORMAL (N=155;67), Month 7 ABOVE
    18
    9
        HC, pre-vacc. BELOW (N=75;33), Month 7 NORMAL
    16
    7
        HC, pre-vacc. BELOW (N=75;33), Month 7 BELOW
    59
    26
        HC, pre-vacc. BELOW (N=75;33), Month 7 ABOVE
    0
    0
        HC, pre-vacc. NORMAL (N=142;72), Month 7 NORMAL
    104
    52
        HC, pre-vacc. NORMAL (N=142;72), Month 7 BELOW
    38
    20
        HC, pre-vacc. NORMAL (N=142;72), Month 7 ABOVE
    0
    0
        LYM, pre-vacc. ABOVE (N=77;41), Month 7 NORMAL
    23
    11
        LYM, pre-vacc. ABOVE (N=77;41), Month 7 BELOW
    4
    3
        LYM, pre-vacc. ABOVE (N=77;41), Month 7 ABOVE
    50
    27
        LYM, pre-vacc. BELOW (N=41;19), Month 7 NORMAL
    23
    8
        LYM, pre-vacc. BELOW (N=41;19), Month 7 BELOW
    11
    6
        LYM, pre-vacc. BELOW (N=41;19), Month 7 ABOVE
    7
    5
        LYM, pre-vacc. NORMAL (N=99;45), Month 7 NORMAL
    47
    19
        LYM, pre-vacc. NORMAL (N=99;45), Month 7 BELOW
    17
    2
        LYM, pre-vacc. NORMAL (N=99;45), Month 7 ABOVE
    35
    24
        MON, pre-vacc. ABOVE (N=48;35), Month 7 NORMAL
    17
    4
        MON, pre-vacc. ABOVE (N=48;35), Month 7 BELOW
    0
    0
        MON, pre-vacc. ABOVE (N=48;35), Month 7 ABOVE
    31
    31
        MON, pre-vacc. NORMAL (N=169;70), Month 7 NORMAL
    108
    45
        MON, pre-vacc. NORMAL (N=169;70), Month 7 BELOW
    0
    0
        MON, pre-vacc. NORMAL (N=169;70), Month 7 ABOVE
    61
    25
        NEU, pre-vacc. ABOVE (N=8;3), Month 7 NORMAL
    0
    0
        NEU, pre-vacc. ABOVE (N=8;3), Month 7 BELOW
    7
    3
        NEU, pre-vacc. ABOVE (N=8;3), Month 7 ABOVE
    1
    0
        NEU, pre-vacc. BELOW (N=176;91), Month 7 NORMAL
    9
    4
        NEU, pre-vacc. BELOW (N=176;91), Month 7 BELOW
    165
    86
        NEU, pre-vacc. BELOW (N=176;91), Month 7 ABOVE
    2
    1
        NEU, pre-vacc. NORMAL (N=33;11), Month 7 NORMAL
    4
    1
        NEU, pre-vacc. NORMAL (N=33;11), Month 7 BELOW
    26
    10
        NEU, pre-vacc. NORMAL (N=33;11), Month 7 ABOVE
    3
    0
        PLA, pre-vacc. ABOVE (N=17;6), Month 7 NORMAL
    10
    4
        PLA, pre-vacc. ABOVE (N=17;6), Month 7 BELOW
    0
    0
        PLA, pre-vacc. ABOVE (N=17;6), Month 7 ABOVE
    7
    2
        PLA. pre-vacc. BELOW (N=2;3), Month 7 NORMAL
    1
    0
        PLA. pre-vacc. BELOW (N=2;3), Month 7 BELOW
    1
    2
        PLA. pre-vacc. BELOW (N=2;3), Month 7 ABOVE
    0
    1
        PLA, pre-vacc. NORMAL (N=198;96), Month 7 NORMAL
    194
    96
        PLA, pre-vacc. NORMAL (N=198;96), Month 7 BELOW
    0
    0
        PLA, pre-vacc. NORMAL (N=198;96), Month 7 ABOVE
    4
    0
        RBC, pre-vacc. BELOW (N=29;11), Month 7 NORMAL
    10
    3
        RBC, pre-vacc. BELOW (N=29;11), Month 7 BELOW
    19
    8
        RBC, pre-vacc. BELOW (N=29;11), Month 7 ABOVE
    0
    0
        RBC, pre-vacc. NORMAL (N=188;94), Month 7 NORMAL
    176
    89
        RBC, pre-vacc. NORMAL (N=188;94), Month 7 BELOW
    12
    5
        RBC, pre-vacc. NORMAL (N=188;94), Month 7 ABOVE
    0
    0
        WBC, pre-vacc. ABOVE (N=9;7), Month 7 NORMAL
    6
    6
        WBC, pre-vacc. ABOVE (N=9;7), Month 7 BELOW
    0
    0
        WBC, pre-vacc. ABOVE (N=9;7), Month 7 ABOVE
    3
    1
        WBC, pre-vacc. BELOW (N=21;12), Month 7 NORMAL
    5
    6
        WBC, pre-vacc. BELOW (N=21;12), Month 7 BELOW
    16
    6
        WBC, pre-vacc. BELOW (N=21;12), Month 7 ABOVE
    0
    0
        WBC, pre-vacc. NORMAL (N=187;86), Month 7 NORMAL
    158
    72
        WBC, pre-vacc. NORMAL (N=187;86), Month 7 BELOW
    26
    13
        WBC, pre-vacc. NORMAL (N=187;86), Month 7 ABOVE
    3
    1
    No statistical analyses for this end point

    Secondary: Number of Tanzanian subjects with clinically relevant abnormalities in parameters assessed

    		 Close Top of page
    End point title
    		 Number of Tanzanian subjects with clinically relevant abnormalities in parameters assessed
    End point description
    Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
    End point type
    Secondary
    End point timeframe
    At Month 7
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    187
    96
    Units: Subjects
        ALT, pre-vacc. ABOVE (N=3;3), Month 7 NORMAL
    2
    2
        ALT, pre-vacc. ABOVE (N=3;3), Month 7 BELOW
    0
    1
        ALT, pre-vacc. ABOVE (N=3;3), Month 7 ABOVE
    1
    0
        ALT, pre-vacc. BELOW (N=13;11), Month 7 NORMAL
    7
    3
        ALT, pre-vacc. BELOW (N=13;11), Month 7 BELOW
    6
    8
        ALT, pre-vacc. BELOW (N=13;11), Month 7 ABOVE
    0
    0
        ALT, pre-vacc. NORMAL (N=183;85), Month 7 NORMAL
    144
    65
        ALT, pre-vacc. NORMAL (N=183;85), Month 7 BELOW
    39
    20
        ALT, pre-vacc. NORMAL (N=183;85), Month 7 ABOVE
    0
    0
        BAS, pre-vacc. ABOVE (N=21;12), Month 7 NORMAL
    19
    12
        BAS, pre-vacc. ABOVE (N=21;12), Month 7 BELOW
    0
    0
        BAS, pre-vacc. ABOVE (N=21;12), Month 7 ABOVE
    2
    0
        BAS, pre-vacc. NORMAL (N=178;87), Month 7 NORMAL
    163
    81
        BAS, pre-vacc. NORMAL (N=178;87), Month 7 BELOW
    0
    0
        BAS, pre-vacc. NORMAL (N=178;87), Month 7 ABOVE
    15
    6
        CREA, pre-vacc. BELOW (N=43;14), Month 7 NORMAL
    2
    2
        CREA, pre-vacc. BELOW (N=43;14), Month 7 BELOW
    41
    12
        CREA, pre-vacc. BELOW (N=43;14), Month 7 ABOVE
    0
    0
        CREA, pre-vacc. NORMAL (N=156;85), Month 7 NORMAL
    40
    14
        CREA, pre-vacc. NORMAL (N=156;85), Month 7 BELOW
    116
    71
        CREA, pre-vacc. NORMAL (N=156;85), Month 7 ABOVE
    0
    0
        EOS, pre-vacc. ABOVE (N=76;39), Month 7 NORMAL
    14
    4
        EOS, pre-vacc. ABOVE (N=76;39), Month 7 BELOW
    0
    0
        EOS, pre-vacc. ABOVE (N=76;39), Month 7 ABOVE
    61
    35
        EOS, pre-vacc. ABOVE (N=76;39), Month 7 MISSING
    1
    0
        EOS, pre-vacc. NORMAL (N=123;60), Month 7 NORMAL
    92
    52
        EOS, pre-vacc. NORMAL (N=123;60), Month 7 BELOW
    0
    0
        EOS, pre-vacc. NORMAL (N=123;60), Month 7 ABOVE
    31
    8
        HC, pre-vacc. ABOVE (N=1;0), Month 7 NORMAL
    1
    0
        HC, pre-vacc. ABOVE (N=1;0), Month 7 BELOW
    0
    0
        HC, pre-vacc. ABOVE (N=1;0), Month 7 ABOVE
    0
    0
        HC, pre-vacc. BELOW (N=60;35), Month 7 NORMAL
    20
    6
        HC, pre-vacc. BELOW (N=60;35), Month 7 BELOW
    40
    29
        HC, pre-vacc. BELOW (N=60;35), Month 7 ABOVE
    0
    0
        HC, pre-vacc. NORMAL (N=138;64), Month 7 NORMAL
    118
    51
        HC, pre-vacc. NORMAL (N=138;64), Month 7 BELOW
    20
    13
        HC, pre-vacc. NORMAL (N=138;64), Month 7 ABOVE
    0
    0
        LYM, pre-vacc. ABOVE (N=20;8), Month 7 NORMAL
    12
    7
        LYM, pre-vacc. ABOVE (N=20;8), Month 7 BELOW
    0
    0
        LYM, pre-vacc. ABOVE (N=20;8), Month 7 ABOVE
    8
    1
        LYM, pre-vacc. NORMAL (N=179;91), Month 7 NORMAL
    166
    81
        LYM, pre-vacc. NORMAL (N=179;91), Month 7 BELOW
    3
    0
        LYM, pre-vacc. NORMAL (N=179;91), Month 7 ABOVE
    10
    10
        MON, pre-vacc. ABOVE (N=12;7), Month 7 NORMAL
    6
    6
        MON, pre-vacc. ABOVE (N=12;7), Month 7 BELOW
    0
    0
        MON, pre-vacc. ABOVE (N=12;7), Month 7 ABOVE
    6
    1
        MON, pre-vacc. NORMAL (N=187;92), Month 7 NORMAL
    180
    85
        MON, pre-vacc. NORMAL (N=187;92), Month 7 BELOW
    0
    0
        MON, pre-vacc. NORMAL (N=187;92), Month 7 ABOVE
    7
    7
        NEU, pre-vacc. BELOW (N=36;16), Month 7 NORMAL
    13
    9
        NEU, pre-vacc. BELOW (N=36;16), Month 7 BELOW
    22
    7
        NEU, pre-vacc. BELOW (N=36;16), Month 7 ABOVE
    0
    0
        NEU, pre-vacc. BELOW (N=36;16), Month 7 MISSING
    1
    0
        NEU, pre-vacc. NORMAL (N=163;83), Month 7 NORMAL
    145
    70
        NEU, pre-vacc. NORMAL (N=163;83), Month 7 BELOW
    17
    13
        NEU, pre-vacc. NORMAL (N=163;83), Month 7 ABOVE
    1
    0
        PLA, pre-vacc. ABOVE (N=10;3), Month 7 NORMAL
    7
    1
        PLA, pre-vacc. ABOVE (N=10;3), Month 7 BELOW
    0
    0
        PLA, pre-vacc. ABOVE (N=10;3), Month 7 ABOVE
    3
    2
        PLA, pre-vacc. BELOW (N=5;0), Month 7 NORMAL
    4
    0
        PLA, pre-vacc. BELOW (N=5;0), Month 7 BELOW
    1
    0
        PLA, pre-vacc. BELOW (N=5;0), Month 7 ABOVE
    0
    0
        PLA, pre-vacc. NORMAL (N=184;96), Month 7 NORMAL
    180
    92
        PLA, pre-vacc. NORMAL (N=184;96), Month 7 BELOW
    2
    0
        PLA, pre-vacc. NORMAL (N=184;96), Month 7 ABOVE
    2
    4
        RBC, pre-vacc. ABOVE (N=11;7), Month 7 NORMAL
    6
    4
        RBC, pre-vacc. ABOVE (N=11;7), Month 7 BELOW
    0
    0
        RBC, pre-vacc. ABOVE (N=11;7), Month 7 ABOVE
    5
    3
        RBC, pre-vacc. BELOW (N=2;1), Month 7 NORMAL
    1
    0
        RBC, pre-vacc. BELOW (N=2;1), Month 7 BELOW
    1
    1
        RBC, pre-vacc. BELOW (N=2;1), Month 7 ABOVE
    0
    0
        RBC, pre-vacc. NORMAL (N=186;91), Month 7 NORMAL
    177
    90
        RBC, pre-vacc. NORMAL (N=186;91), Month 7 BELOW
    5
    0
        RBC, pre-vacc. NORMAL (N=186;91), Month 7 ABOVE
    4
    1
        WBC, pre-vacc. ABOVE (N=17;7), Month 7 NORMAL
    13
    6
        WBC, pre-vacc. ABOVE (N=17;7), Month 7 BELOW
    0
    0
        WBC, pre-vacc. ABOVE (N=17;7), Month 7 ABOVE
    4
    1
        WBC, pre-vacc. BELOW (N=0;2), Month 7 NORMAL
    0
    2
        WBC, pre-vacc. BELOW (N=0;2), Month 7 BELOW
    0
    0
        WBC, pre-vacc. BELOW (N=0;2), Month 7 ABOVE
    0
    0
        WBC, pre-vacc. NORMAL (N=182;90), Month 7 NORMAL
    177
    86
        WBC, pre-vacc. NORMAL (N=182;90), Month 7 BELOW
    4
    2
        WBC, pre-vacc. NORMAL (N=182;90), Month 7 ABOVE
    1
    2
    No statistical analyses for this end point

    Secondary: Number of Senegalese subjects with clinically relevant abnormalities in parameters assessed

    		 Close Top of page
    End point title
    		 Number of Senegalese subjects with clinically relevant abnormalities in parameters assessed
    End point description
    Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    211
    102
    Units: Subjects
        ALT, pre-vacc. ABOVE (N=8;4), Month 12 NORMAL
    8
    4
        ALT, pre-vacc.ABOVE (N=8;4), Month 12 BELOW
    0
    0
        ALT, pre-vacc. ABOVE (N=8;4), Month 12 ABOVE
    0
    0
        ALT, pre-vacc. BELOW (N=38;17), Month 12 NORMAL
    17
    9
        ALT, pre-vacc. BELOW (N=38;17), Month 12 BELOW
    21
    8
        ALT, pre-vacc. BELOW (N=38;17), Month 12 ABOVE
    0
    0
        ALT, pre-vacc. NORMAL (N=165;81), Month 12 NORMAL
    139
    61
        ALT, pre-vacc. NORMAL (N=165;81), Month 12 BELOW
    24
    17
        ALT, pre-vacc. NORMAL (N=165;81), Month 12 ABOVE
    2
    3
        BAS, pre-vacc. NORMAL (N=211;102), Month 12 NORMAL
    210
    102
        BAS, pre-vacc. NORMAL (N=211;102), Month 12 BELOW
    0
    0
        BAS, pre-vacc. NORMAL (N=211;102), Month 12 ABOVE
    1
    0
        CREA, pre-vacc. ABOVE (N=2;1), Month 12 NORMAL
    1
    0
        CREA, pre-vacc. ABOVE (N=2;1), Month 12 BELOW
    0
    1
        CREA, pre-vacc. ABOVE (N=2;1), Month 12 ABOVE
    1
    0
        CREA, pre-vacc. BELOW (N=56;29), Month 12 NORMAL
    13
    6
        CREA, pre-vacc. BELOW (N=56;29), Month 12 BELOW
    43
    23
        CREA, pre-vacc. BELOW (N=56;29), Month 12 ABOVE
    0
    0
        CREA, pre-vacc. NORMAL (N=153;72), Month 12 NORMAL
    130
    64
        CREA, pre-vacc. NORMAL (N=153;72), Month 12 BELOW
    23
    8
        CREA, pre-vacc. NORMAL (N=153;72), Month 12 ABOVE
    0
    0
        EOS, pre-vacc. ABOVE (N=43;28), Month 12 NORMAL
    14
    11
        EOS, pre-vacc. ABOVE (N=43;28), Month 12 BELOW
    1
    0
        EOS, pre-vacc. ABOVE (N=43;28), Month 12 ABOVE
    28
    17
        EOS, pre-vacc. BELOW (N=19;10), Month 12 NORMAL
    13
    6
        EOS, pre-vacc. BELOW (N=19;10), Month 12 BELOW
    6
    3
        EOS, pre-vacc. BELOW (N=19;10), Month 12 ABOVE
    0
    1
        EOS, pre-vacc. NORMAL (N=149;64), Month 12 NORMAL
    126
    52
        EOS, pre-vacc. NORMAL (N=149;64), Month 12 BELOW
    6
    2
        EOS, pre-vacc. NORMAL (N=149;64), Month 12 ABOVE
    17
    10
        HC, pre-vacc. BELOW (N=71;33), Month 12 NORMAL
    15
    10
        HC, pre-vacc. BELOW (N=71;33), Month 12 BELOW
    56
    23
        HC, pre-vacc. BELOW (N=71;33), Month 12 ABOVE
    0
    0
        HC, pre-vacc. NORMAL (N=140;69), Month 12 NORMAL
    108
    45
        HC, pre-vacc. NORMAL (N=140;69), Month 12 BELOW
    32
    24
        HC, pre-vacc. NORMAL (N=140;69), Month 12 ABOVE
    0
    0
        LYM, pre-vacc. ABOVE (N=75;41), Month 12 NORMAL
    24
    16
        LYM, pre-vacc. ABOVE (N=75;41), Month 12 BELOW
    4
    3
        LYM, pre-vacc. ABOVE (N=75;41), Month 12 ABOVE
    47
    22
        LYM, pre-vacc. BELOW (N=38;19), Month 12 NORMAL
    9
    8
        LYM, pre-vacc. BELOW (N=38;19), Month 12 BELOW
    15
    5
        LYM, pre-vacc. BELOW (N=38;19), Month 12 ABOVE
    14
    6
        LYM, pre-vacc. NORMAL (N=98;42), Month 12 NORMAL
    48
    24
        LYM, pre-vacc. NORMAL (N=98;42), Month 12 BELOW
    27
    4
        LYM, pre-vacc. NORMAL (N=98;42), Month 12 ABOVE
    23
    14
        MON, pre-vacc. ABOVE (N=45;34), Month 12 NORMAL
    13
    10
        MON, pre-vacc. ABOVE (N=45;34), Month 12 BELOW
    0
    0
        MON, pre-vacc. ABOVE (N=45;34), Month 12 ABOVE
    32
    24
        MON, pre-vacc. NORMAL (N=166;68), Month 12 NORMAL
    102
    38
        MON, pre-vacc. NORMAL (N=166;68), Month 12 BELOW
    0
    0
        MON, pre-vacc. NORMAL (N=166;68), Month 12 ABOVE
    64
    30
        NEU, pre-vacc. ABOVE (N=8;3), Month 12 NORMAL
    4
    0
        NEU, pre-vacc. ABOVE (N=8;3), Month 12 BELOW
    4
    3
        NEU, pre-vacc. ABOVE (N=8;3), Month 12 ABOVE
    0
    0
        NEU, pre-vacc. BELOW (N=173;88), Month 12 NORMAL
    11
    5
        NEU, pre-vacc. BELOW (N=173;88), Month 12 BELOW
    160
    83
        NEU, pre-vacc. BELOW (N=173;88), Month 12 ABOVE
    2
    0
        NEU, pre-vacc. NORMAL (N=30;11), Month 12 NORMAL
    7
    1
        NEU, pre-vacc. NORMAL (N=30;11), Month 12 BELOW
    22
    9
        NEU, pre-vacc. NORMAL (N=30;11), Month 12 ABOVE
    1
    1
        PLA, pre-vacc. ABOVE (N=17;6), Month 12 NORMAL
    13
    4
        PLA, pre-vacc. ABOVE (N=17;6), Month 12 BELOW
    0
    0
        PLA, pre-vacc. ABOVE (N=17;6), Month 12 ABOVE
    4
    2
        PLA. pre-vacc. BELOW (N=2;3), Month 12 NORMAL
    1
    1
        PLA. pre-vacc. BELOW (N=2;3), Month 12 BELOW
    1
    2
        PLA. pre-vacc. BELOW (N=2;3), Month 12 ABOVE
    0
    0
        PLA, pre-vacc. NORMAL (N=192;93), Month 12 NORMAL
    188
    93
        PLA, pre-vacc. NORMAL (N=198;93), Month 12 BELOW
    3
    0
        PLA, pre-vacc. NORMAL (N=198;93), Month 12 ABOVE
    1
    0
        RBC, pre-vacc. BELOW (N=27;11), Month 12 NORMAL
    8
    5
        RBC, pre-vacc. BELOW (N=27;11), Month 12 BELOW
    19
    6
        RBC, pre-vacc. BELOW (N=27;11), Month 12 ABOVE
    0
    0
        RBC, pre-vacc. NORMAL (N=184;91), Month 12 NORMAL
    169
    80
        RBC, pre-vacc. NORMAL (N=184;91), Month 12 BELOW
    15
    11
        RBC, pre-vacc. NORMAL (N=184;91), Month 12 ABOVE
    0
    0
        WBC, pre-vacc. ABOVE (N=8;7), Month 12 NORMAL
    6
    7
        WBC, pre-vacc. ABOVE (N=8;7), Month 12 BELOW
    0
    0
        WBC, pre-vacc. ABOVE (N=8;7), Month 12 ABOVE
    2
    0
        WBC, pre-vacc. BELOW (N=19;12), Month 12 NORMAL
    10
    5
        WBC, pre-vacc. BELOW (N=19;12), Month 12 BELOW
    9
    7
        WBC, pre-vacc. BELOW (N=19;12), Month 12 ABOVE
    0
    0
        WBC, pre-vacc. NORMAL (N=184;83), Month 12 NORMAL
    156
    64
        WBC, pre-vacc. NORMAL (N=184;83), Month 12 BELOW
    22
    16
        WBC, pre-vacc. NORMAL (N=184;83), Month 12 ABOVE
    6
    3
    No statistical analyses for this end point

    Secondary: Number of Tanzanian subjects with clinically relevant abnormalities in parameters assessed

    		 Close Top of page
    End point title
    		 Number of Tanzanian subjects with clinically relevant abnormalities in parameters assessed
    End point description
    Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 Cervarix Group Placebo Group
    Number of subjects analysed
    194
    100
    Units: Subjects
        ALT, pre-vacc. ABOVE (N=3;4), Month 12 NORMAL
    2
    2
        ALT, pre-vacc. ABOVE (N=3;4), Month 12 BELOW
    0
    1
        ALT, pre-vacc. ABOVE (N=3;4), Month 12 ABOVE
    1
    1
        ALT, pre-vacc. BELOW (N=13;11), Month 12 NORMAL
    12
    8
        ALT, pre-vacc. BELOW (N=13;11), Month 12 BELOW
    1
    3
        ALT, pre-vacc. BELOW (N=13;11), Month 12 ABOVE
    0
    0
        ALT, pre-vacc. NORMAL (N=190;87), Month 12 NORMAL
    166
    73
        ALT, pre-vacc. NORMAL (N=190;87), Month 12 BELOW
    24
    13
        ALT, pre-vacc. NORMAL (N=190;87), Month 12 ABOVE
    0
    1
        BAS, pre-vacc. ABOVE (N=23;13), Month 12 NORMAL
    21
    12
        BAS, pre-vacc. ABOVE (N=23;13), Month 12 BELOW
    0
    0
        BAS, pre-vacc. ABOVE (N=23;13), Month 12 ABOVE
    2
    1
        BAS, pre-vacc. NORMAL (N=183;89), Month 12 NORMAL
    174
    81
        BAS, pre-vacc. NORMAL (N=183;89), Month 12 BELOW
    0
    0
        BAS, pre-vacc. NORMAL (N=183;89), Month 12 ABOVE
    9
    8
        CREA, pre-vacc. BELOW (N=42;14), Month 12 NORMAL
    2
    0
        CREA, pre-vacc. BELOW (N=42;14), Month 12 BELOW
    40
    14
        CREA, pre-vacc. BELOW (N=42;14), Month 12 ABOVE
    0
    0
        CREA, pre-vacc. NORMAL (N=164;88), Month 12 NORMAL
    48
    19
        CREA, pre-vacc. NORMAL (N=164;88), Month 12 BELOW
    116
    69
        CREA, pre-vacc. NORMAL (N=164;88), Month 12 ABOVE
    0
    0
        EOS, pre-vacc. ABOVE (N=79;43), Month 12 NORMAL
    22
    10
        EOS, pre-vacc. ABOVE (N=79;43), Month 12 BELOW
    0
    0
        EOS, pre-vacc. ABOVE (N=79;43), Month 12 ABOVE
    57
    33
        EOS, pre-vacc. NORMAL (N=127;59), Month 12 NORMAL
    93
    48
        EOS, pre-vacc. NORMAL (N=127;59), Month 12 BELOW
    0
    0
        EOS, pre-vacc. NORMAL (N=127;59), Month 12 ABOVE
    34
    11
        HC, pre-vacc. BELOW (N=63;38), Month 12 NORMAL
    29
    10
        HC, pre-vacc. BELOW (N=63;38), Month 12 BELOW
    34
    28
        HC, pre-vacc. BELOW (N=63;38), Month 12 ABOVE
    0
    0
        HC, pre-vacc. NORMAL (N=143;64), Month 12 NORMAL
    107
    48
        HC, pre-vacc. NORMAL (N=143;64), Month 12 BELOW
    36
    16
        HC, pre-vacc. NORMAL (N=143;64), Month 12 ABOVE
    0
    0
        LYM, pre-vacc. ABOVE (N=18;8), Month 12 NORMAL
    9
    3
        LYM, pre-vacc. ABOVE (N=18;8), Month 12 BELOW
    0
    0
        LYM, pre-vacc. ABOVE (N=18;8), Month 12 ABOVE
    9
    5
        LYM, pre-vacc. NORMAL (N=188;94), Month 12 NORMAL
    168
    81
        LYM, pre-vacc. NORMAL (N=188;94), Month 12 BELOW
    0
    2
        LYM, pre-vacc. NORMAL (N=188;94), Month 12 ABOVE
    20
    11
        MON, pre-vacc. ABOVE (N=12;7), Month 12 NORMAL
    8
    6
        MON, pre-vacc. ABOVE (N=12;7), Month 12 BELOW
    0
    0
        MON, pre-vacc. ABOVE (N=12;7), Month 12 ABOVE
    4
    1
        MON, pre-vacc. NORMAL (N=194;95), Month 12 NORMAL
    184
    88
        MON, pre-vacc. NORMAL (N=194;95), Month 12 BELOW
    0
    0
        MON, pre-vacc. NORMAL (N=194;95), Month 12 ABOVE
    10
    7
        NEU, pre-vacc. BELOW (N=36;17), Month 12 NORMAL
    18
    6
        NEU, pre-vacc. BELOW (N=36;17), Month 12 BELOW
    18
    11
        NEU, pre-vacc. BELOW (N=36;17), Month 12 ABOVE
    0
    0
        NEU, pre-vacc. NORMAL (N=170;85), Month 12 NORMAL
    138
    72
        NEU, pre-vacc. NORMAL (N=170;85), Month 12 BELOW
    32
    13
        NEU, pre-vacc. NORMAL (N=170;85), Month 12 ABOVE
    0
    0
        PLA, pre-vacc. ABOVE (N=10;2), Month 12 NORMAL
    8
    1
        PLA, pre-vacc. ABOVE (N=10;2), Month 12 BELOW
    0
    0
        PLA, pre-vacc. ABOVE (N=10;2), Month 12 ABOVE
    2
    1
        PLA, pre-vacc. BELOW (N=5;0), Month 12 NORMAL
    5
    0
        PLA, pre-vacc. BELOW (N=5;0), Month 12 BELOW
    0
    0
        PLA, pre-vacc. BELOW (N=5;0), Month 12 ABOVE
    0
    0
        PLA, pre-vacc. NORMAL (N=191;100), Month 12 NORMAL
    185
    96
        PLA, pre-vacc. NORMAL (N=191;100), Month 12 BELOW
    1
    2
        PLA, pre-vacc. NORMAL (N=191;100), Month 12 ABOVE
    5
    2
        RBC, pre-vacc. ABOVE (N=10;7), Month 12 NORMAL
    5
    3
        RBC, pre-vacc. ABOVE (N=10;7), Month 12 BELOW
    0
    0
        RBC, pre-vacc. ABOVE (N=10;7), Month 12 ABOVE
    5
    4
        RBC, pre-vacc. BELOW (N=3;2), Month 12 NORMAL
    2
    0
        RBC, pre-vacc. BELOW (N=3;2), Month 12 BELOW
    1
    2
        RBC, pre-vacc. BELOW (N=3;2), Month 12 ABOVE
    0
    0
        RBC, pre-vacc. NORMAL (N=193;93), Month 12 NORMAL
    182
    91
        RBC, pre-vacc. NORMAL (N=193;93), Month 12 BELOW
    6
    2
        RBC, pre-vacc. NORMAL (N=193;93), Month 12 ABOVE
    5
    0
        WBC, pre-vacc. ABOVE (N=17;6), Month 12 NORMAL
    12
    5
        WBC, pre-vacc. ABOVE (N=17;6), Month 12 BELOW
    0
    0
        WBC, pre-vacc. ABOVE (N=17;6), Month 12 ABOVE
    5
    1
        WBC, pre-vacc. BELOW (N=0;2), Month 12 NORMAL
    0
    2
        WBC, pre-vacc. BELOW (N=0;2), Month 12 BELOW
    0
    0
        WBC, pre-vacc. BELOW (N=0;2), Month 12 ABOVE
    0
    0
        WBC, pre-vacc. NORMAL (N=189;94), Month 12 NORMAL
    165
    85
        WBC, pre-vacc. NORMAL (N=189;94), Month 12 BELOW
    14
    5
        WBC, pre-vacc. NORMAL (N=189;94), Month 12 ABOVE
    10
    4
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: within 7 days (Day 0-6) after vaccination; Unsolicited AEs: within 30 days (Day 0-29) after any vaccination; SAEs: during the whole study period (from Day 0 up to Month 12).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.

    Serious adverse events
    		 Cervarix Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 450 (3.78%)
    14 / 226 (6.19%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous complete
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpartum haemorrhage
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Neuropathy vitamin b6 deficiency
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (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 pain lower
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (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
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (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
    Malaria
         subjects affected / exposed
    10 / 450 (2.22%)
    11 / 226 (4.87%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 450 (0.00%)
    3 / 226 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burn infection
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysentery
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (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 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic inflammatory disease
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyomyositis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (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
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         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: 0%
    Non-serious adverse events
    		 Cervarix Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    433 / 450 (96.22%)
    216 / 226 (95.58%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    3 / 450 (0.67%)
    2 / 226 (0.88%)
         occurrences all number
    3
    2
    Orthostatic hypotension
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Phlebitis
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Chest discomfort
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    5 / 450 (1.11%)
    1 / 226 (0.44%)
         occurrences all number
    5
    1
    Fatigue
         subjects affected / exposed
    111 / 450 (24.67%)
    42 / 226 (18.58%)
         occurrences all number
    130
    50
    Influenza like illness
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Injection site rash
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    376 / 450 (83.56%)
    168 / 226 (74.34%)
         occurrences all number
    779
    279
    Pyrexia
         subjects affected / exposed
    147 / 450 (32.67%)
    71 / 226 (31.42%)
         occurrences all number
    235
    110
    Swelling
         subjects affected / exposed
    74 / 450 (16.44%)
    27 / 226 (11.95%)
         occurrences all number
    86
    32
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    23 / 450 (5.11%)
    10 / 226 (4.42%)
         occurrences all number
    25
    10
    Genital discharge
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Menstruation delayed
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Metrorrhagia
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Oligomenorrhoea
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Ovarian cyst
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Pelvic pain
         subjects affected / exposed
    3 / 450 (0.67%)
    0 / 226 (0.00%)
         occurrences all number
    3
    0
    Vaginal discharge
         subjects affected / exposed
    6 / 450 (1.33%)
    4 / 226 (1.77%)
         occurrences all number
    6
    4
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchopneumopathy
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    13 / 450 (2.89%)
    7 / 226 (3.10%)
         occurrences all number
    13
    8
    Dysphonia
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    8 / 450 (1.78%)
    6 / 226 (2.65%)
         occurrences all number
    9
    6
    Rhinorrhoea
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    2 / 450 (0.44%)
    1 / 226 (0.44%)
         occurrences all number
    2
    1
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Burns first degree
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Human bite
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Limb traumatic amputation
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Soft tissue injury
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Wound
         subjects affected / exposed
    2 / 450 (0.44%)
    1 / 226 (0.44%)
         occurrences all number
    2
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Head discomfort
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    201 / 450 (44.67%)
    116 / 226 (51.33%)
         occurrences all number
    298
    157
    Sensory disturbance
         subjects affected / exposed
    2 / 450 (0.44%)
    0 / 226 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Lymphadenitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    5 / 450 (1.11%)
    2 / 226 (0.88%)
         occurrences all number
    5
    2
    Vertigo
         subjects affected / exposed
    13 / 450 (2.89%)
    3 / 226 (1.33%)
         occurrences all number
    15
    4
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    8 / 450 (1.78%)
    1 / 226 (0.44%)
         occurrences all number
    8
    1
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Eye allergy
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Eye irritation
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Eye pain
         subjects affected / exposed
    4 / 450 (0.89%)
    0 / 226 (0.00%)
         occurrences all number
    4
    0
    Eye pruritus
         subjects affected / exposed
    2 / 450 (0.44%)
    0 / 226 (0.00%)
         occurrences all number
    2
    0
    Eyelid oedema
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Lacrimation increased
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Myopia
         subjects affected / exposed
    1 / 450 (0.22%)
    2 / 226 (0.88%)
         occurrences all number
    1
    2
    Visual impairment
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    16 / 450 (3.56%)
    7 / 226 (3.10%)
         occurrences all number
    17
    7
    Abdominal pain upper
         subjects affected / exposed
    1 / 450 (0.22%)
    2 / 226 (0.88%)
         occurrences all number
    1
    2
    Constipation
         subjects affected / exposed
    0 / 450 (0.00%)
    2 / 226 (0.88%)
         occurrences all number
    0
    2
    Dental caries
         subjects affected / exposed
    6 / 450 (1.33%)
    2 / 226 (0.88%)
         occurrences all number
    6
    2
    Diarrhoea
         subjects affected / exposed
    6 / 450 (1.33%)
    3 / 226 (1.33%)
         occurrences all number
    6
    3
    Dyspepsia
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Enteritis
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    4 / 450 (0.89%)
    0 / 226 (0.00%)
         occurrences all number
    4
    0
    Gastrointestinal disorder
         subjects affected / exposed
    118 / 450 (26.22%)
    56 / 226 (24.78%)
         occurrences all number
    143
    66
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Gingivitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Glossitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Hyperchlorhydria
         subjects affected / exposed
    2 / 450 (0.44%)
    0 / 226 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    2 / 450 (0.44%)
    2 / 226 (0.88%)
         occurrences all number
    2
    2
    Oesophagitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Peptic ulcer
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    6 / 450 (1.33%)
    3 / 226 (1.33%)
         occurrences all number
    6
    3
    Vomiting
         subjects affected / exposed
    2 / 450 (0.44%)
    0 / 226 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Pigmentation disorder
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    71 / 450 (15.78%)
    33 / 226 (14.60%)
         occurrences all number
    84
    38
    Rash papular
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Skin disorder
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Skin exfoliation
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    68 / 450 (15.11%)
    28 / 226 (12.39%)
         occurrences all number
    81
    33
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    79 / 450 (17.56%)
    36 / 226 (15.93%)
         occurrences all number
    97
    41
    Back pain
         subjects affected / exposed
    4 / 450 (0.89%)
    2 / 226 (0.88%)
         occurrences all number
    4
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    90 / 450 (20.00%)
    38 / 226 (16.81%)
         occurrences all number
    113
    46
    Neck pain
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    2 / 450 (0.44%)
    2 / 226 (0.88%)
         occurrences all number
    2
    2
    Torticollis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Abscess
         subjects affected / exposed
    2 / 450 (0.44%)
    0 / 226 (0.00%)
         occurrences all number
    2
    0
    Abscess limb
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Adenoiditis
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Amoebiasis
         subjects affected / exposed
    1 / 450 (0.22%)
    3 / 226 (1.33%)
         occurrences all number
    1
    3
    Arthritis bacterial
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Body tinea
         subjects affected / exposed
    7 / 450 (1.56%)
    3 / 226 (1.33%)
         occurrences all number
    7
    3
    Bronchitis
         subjects affected / exposed
    4 / 450 (0.89%)
    4 / 226 (1.77%)
         occurrences all number
    4
    4
    Bronchopneumonia
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Candidiasis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Chlamydial infection
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Cutaneous larva migrans
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    2 / 450 (0.44%)
    1 / 226 (0.44%)
         occurrences all number
    2
    1
    Fungal skin infection
         subjects affected / exposed
    4 / 450 (0.89%)
    2 / 226 (0.88%)
         occurrences all number
    4
    2
    Gastroenteritis
         subjects affected / exposed
    3 / 450 (0.67%)
    1 / 226 (0.44%)
         occurrences all number
    3
    1
    Giardiasis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Gingival infection
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Helminthic infection
         subjects affected / exposed
    8 / 450 (1.78%)
    1 / 226 (0.44%)
         occurrences all number
    8
    1
    Hookworm infection
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Hordeolum
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Influenza
         subjects affected / exposed
    8 / 450 (1.78%)
    1 / 226 (0.44%)
         occurrences all number
    8
    1
    Malaria
         subjects affected / exposed
    56 / 450 (12.44%)
    38 / 226 (16.81%)
         occurrences all number
    66
    44
    Measles
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    9 / 450 (2.00%)
    12 / 226 (5.31%)
         occurrences all number
    10
    12
    Otitis media
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Parasitic gastroenteritis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Pelvic inflammatory disease
         subjects affected / exposed
    4 / 450 (0.89%)
    1 / 226 (0.44%)
         occurrences all number
    5
    1
    Pericoronitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    2 / 450 (0.44%)
    0 / 226 (0.00%)
         occurrences all number
    2
    0
    Pneumonia
         subjects affected / exposed
    2 / 450 (0.44%)
    3 / 226 (1.33%)
         occurrences all number
    2
    3
    Respiratory tract infection
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Rhinitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Sepsis
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Shigella infection
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Tinea capitis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Tinea versicolour
         subjects affected / exposed
    1 / 450 (0.22%)
    1 / 226 (0.44%)
         occurrences all number
    1
    1
    Tonsillitis
         subjects affected / exposed
    4 / 450 (0.89%)
    2 / 226 (0.88%)
         occurrences all number
    4
    2
    Trichuriasis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 450 (2.22%)
    5 / 226 (2.21%)
         occurrences all number
    11
    5
    Vaginal infection
         subjects affected / exposed
    2 / 450 (0.44%)
    0 / 226 (0.00%)
         occurrences all number
    2
    0
    Vaginitis bacterial
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Varicella
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Vulvitis
         subjects affected / exposed
    1 / 450 (0.22%)
    2 / 226 (0.88%)
         occurrences all number
    1
    2
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 450 (0.22%)
    0 / 226 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 450 (0.00%)
    1 / 226 (0.44%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2007
    - The global sample size has decreased from 999 subjects to 666 subjects. - The temperature monitoring devices used during storage of the vaccine have been changed. - Cervarix has been licensed in Australia, Kenya and the United Arab Emirates. - An abbreviated title has been added to the Title Page. - Medical history to include information concerning contraception and smoking. The medical history will also be obtained at Visit 1 in addition to the screening visit, and the medical history information is to be recorded in the eCRF.
    12 Dec 2008
    - Two interim analyses (1 and 2) have been added which will be performed when: (1) all subjects enrolled in Senegal have completed Visit 6 (Month 7) and (2) all subjects in Tanzania have completed Visit 6 (Month 7). This takes into account different rates of study activities in the two countries and enables the analysis of results from the different countries separately. - The list of study procedures, study design overview and statistical considerations have been updated to include the two interim analyses. - The list of contributing authors has been updated. - Reference to the current version of the IB and recent references have been added. - Minor corrections such as inconsistencies, formatting and typos have been made. - For clarity, cross-referencing to the first amendment has been removed.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 04 14:51:46 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA