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   43861   clinical trials with a EudraCT protocol, of which   7284   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 post-marketing surveillance (PMS) study to monitor the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ human papillomavirus (HPV) vaccine (Cervarix) in 3,000 healthy female Filipino subjects when administered according to the Prescribing Information from the age of 10 years onwards.

    Summary
    EudraCT number
    		 2017-000458-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Jan 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    09 Jun 2018
    First version publication date
    24 Feb 2018
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Non-serious adverse events section: Value corrected for the row - Total subjects affected by non serious adverse events, subjects affected / exposed

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    108160
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00730847
    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 Aug 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ human papillomavirus vaccine (Cervarix) in 3,000 healthy female Filipino subjects.
    Protection of trial subjects
    All 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. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Sep 2008
    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
    Philippines: 743
    Worldwide total number of subjects
    743
    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)
    143
    Adolescents (12-17 years)
    300
    Adults (18-64 years)
    300
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Since this was a post-marketing study (PMS), subjects may have received one or two doses of Cervarix outside of the PMS.

    Pre-assignment
    Screening details
    		 Out of 743 subjects enrolled in the study, only 596 subjects received study vaccination. The whole set of data was not cleaned for this study. Analysis was performed on subjects with cleaned data and on subjects with missing data or unresolved data queries, or both. The overall group includes both cleaned and not cleaned data.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This study was conducted in an open manner.

    Arms
    Arm title
    		 Cervarix Group
    Arm description
    		 Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    HPV-16/18 VLP/AS04 vaccine
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects were administered a 0.5 mL dose of the vaccine as an intramuscular injection in the deltoid region, according to a 0, 1 and 6-month schedule.

    Number of subjects in period 1 [1]
    		Cervarix Group
    Started
    596
    Completed
    465
    Not completed
    131
         Consent withdrawn by subject
    16
         Adverse event, non-fatal
    1
         Unspecified
    24
         Lost to follow-up
    67
         Protocol deviation
    2
         Unknown completion status
    21
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 743 subjects enrolled in the study, only 596 subjects received study vaccination.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.

    Reporting group values
    		 Cervarix Group Total
    Number of subjects
    		 596
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.8 ( 10.27 ) -
    Gender categorical
    Units: Subjects
        Female
    		 596 596
        Male
    		 0 0
    Race/Ethnicity
    Units: Subjects
        South Asian
    		 594 594
        Chinese
    		 1 1
        Not specified
    		 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.

    Primary: Number of subjects reporting any and Grade 3 solicited local symptoms

    		 Close Top of page
    End point title
    		 Number of subjects reporting any and Grade 3 solicited local symptoms [1]
    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. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).
    End point type
    Primary
    End point timeframe
    During the 7-day follow-up period (Days 0-6) after each dose and across doses
    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
    Number of subjects analysed
    578
    Units: Subjects
        Any Pain, Dose 1 (N=576)
    402
        Grade 3 Pain, Dose 1 (N=576)
    25
        Any Redness, Dose 1 (N=576)
    116
        Grade 3 Redness, Dose 1 (N=576)
    0
        Any Swelling, Dose 1 (N=576)
    76
        Grade 3 Swelling, Dose 1 (N=576)
    3
        Any Pain, Dose 2 (N=531)
    309
        Grade 3 Pain, Dose 2 (N=531)
    16
        Any Redness, Dose 2 (N=531)
    106
        Grade 3 Redness, Dose 2 (N=531)
    0
        Any Swelling, Dose 2 (N=531)
    60
        Grade 3 Swelling, Dose 2 (N=531)
    0
        Any Pain, Dose 3 (N=482)
    211
        Grade 3 Pain, Dose 3 (N=482)
    7
        Any Redness, Dose 3 (N=482)
    69
        Grade 3 Redness, Dose 3 (N=482)
    2
        Any Swelling, Dose 3 (N=482)
    47
        Grade 3 Swelling, Dose 3 (N=482)
    1
        Any Pain, Across Doses (N=578)
    430
        Grade 3 Pain, Across Doses (N=578)
    38
        Any Redness, Across Doses (N=578)
    168
        Grade 3 Redness, Across Doses (N=578)
    2
        Any Swelling, Across Doses (N=578)
    119
        Grade 3 Swelling, Across Doses (N=578)
    4
    No statistical analyses for this end point

    Primary: Number of subjects reporting any, Grade 3 and related solicited general symptoms

    		 Close Top of page
    End point title
    		 Number of subjects reporting any, Grade 3 and related solicited general symptoms [2]
    End point description
    Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0°C.
    End point type
    Primary
    End point timeframe
    During the 7-day follow-up period (Days 0-6) after each dose and across doses
    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
    Number of subjects analysed
    576
    Units: Subjects
        Any Arthralgia, Dose 1 (N=575)
    76
        Grade 3 Arthralgia, Dose 1 (N=575)
    2
        Related Arthralgia, Dose 1 (N=575)
    35
        Any Fatigue, Dose 1 (N=575)
    120
        Grade 3 Fatigue, Dose 1 (N=575)
    4
        Related Fatigue, Dose 1 (N=575)
    53
        Any Fever, Dose 1 (N=575)
    17
        Grade 3 Fever, Dose 1 (N=575)
    1
        Related Fever, Dose 1 (N=575)
    7
        Any Gastrointestinal, Dose 1 (N=575)
    46
        Grade 3 Gastrointestinal, Dose 1 (N=575)
    3
        Related Gastrointestinal, Dose 1 (N=575)
    10
        Any Headache, Dose 1 (N=575)
    90
        Grade 3 Headache, Dose 1 (N=575)
    3
        Related Headache, Dose 1 (N=575)
    29
        Any Myalgia, Dose 1 (N=575)
    91
        Grade 3 Myalgia, Dose 1 (N=575)
    4
        Related Myalgia, Dose 1 (N=575)
    39
        Any Rash, Dose 1 (N=575)
    9
        Grade 3 Rash, Dose 1 (N=575)
    0
        Related Rash, Dose 1 (N=575)
    4
        Any Urticaria, Dose 1 (N=575)
    8
        Grade 3 Urticaria, Dose 1 (N=575)
    0
        Related Urticaria, Dose 1 (N=575)
    3
        Any Arthralgia, Dose 2 (N=529)
    43
        Grade 3 Arthralgia, Dose 2 (N=529)
    1
        Related Arthralgia, Dose 2 (N=529)
    15
        Any Fatigue, Dose 2 (N=529)
    81
        Grade 3 Fatigue, Dose 2 (N=529)
    6
        Related Fatigue, Dose 2 (N=529)
    35
        Any Fever, Dose 2 (N=529)
    11
        Grade 3 Fever, Dose 2 (N=529)
    0
        Related Fever, Dose 2 (N=529)
    9
        Any Gastrointestinal, Dose 2 (N=529)
    32
        Grade 3 Gastrointestinal, Dose 2 (N=529)
    1
        Related Gastrointestinal, Dose 2 (N=529)
    9
        Any Headache, Dose 2 (N=529)
    55
        Grade 3 Headache, Dose 2 (N=529)
    3
        Related Headache, Dose 2 (N=529)
    20
        Any Myalgia, Dose 2 (N=529)
    52
        Grade 3 Myalgia, Dose 2 (N=529)
    2
        Related Myalgia, Dose 2 (N=529)
    20
        Any Rash, Dose 2 (N=529)
    7
        Grade 3 Rash, Dose 2 (N=529)
    1
        Related Rash, Dose 2 (N=529)
    3
        Any Urticaria, Dose 2 (N=529)
    6
        Grade 3 Urticaria, Dose 2 (N=529)
    1
        Related Urticaria, Dose 2 (N=529)
    1
        Any Arthralgia, Dose 3 (N=481)
    30
        Grade 3 Arthralgia, Dose 3 (N=481)
    3
        Related Arthralgia, Dose 3 (N=481)
    13
        Any Fatigue, Dose 3 (N=481)
    57
        Grade 3 Fatigue, Dose 3 (N=481)
    3
        Related Fatigue, Dose 3 (N=481)
    28
        Any Fever, Dose 3 (N=481)
    12
        Grade 3 Fever, Dose 3 (N=481)
    0
        Related Fever, Dose 3 (N=481)
    8
        Any Gastrointestinal, Dose 3 (N=481)
    15
        Grade 3 Gastrointestinal, Dose 3 (N=481)
    0
        Related Gastrointestinal, Dose 3 (N=481)
    6
        Any Headache, Dose 3 (N=481)
    39
        Grade 3 Headache, Dose 3 (N=481)
    2
        Related Headache, Dose 3 (N=481)
    13
        Any Myalgia, Dose 3 (N=481)
    30
        Grade 3 Myalgia, Dose 3 (N=481)
    1
        Related Myalgia, Dose 3 (N=481)
    13
        Any Rash, Dose 3 (N=481)
    4
        Grade 3 Rash, Dose 3 (N=481)
    1
        Related Rash, Dose 3 (N=481)
    2
        Any Urticaria, Dose 3 (N=481)
    2
        Grade 3 Urticaria, Dose 3 (N=481)
    0
        Related Urticaria, Dose 3 (N=481)
    0
        Any Arthralgia, Across doses (N=576)
    102
        Grade 3 Arthralgia, Across doses (N=576)
    6
        Related Arthralgia, Across doses (N=576)
    48
        Any Fatigue, Across doses (N=576)
    165
        Grade 3 Fatigue, Across doses (N=576)
    11
        Related Fatigue, Across doses (N=576)
    72
        Any Fever, Across doses (N=576)
    32
        Grade 3 Fever, Across doses (N=576)
    1
        Related Fever, Across doses (N=576)
    19
        Any Gastrointestinal, Across doses (N=576)
    68
        Grade 3 Gastrointestinal, Across doses (N=576)
    4
        Related Gastrointestinal, Across doses (N=576)
    19
        Any Headache, Across doses (N=576)
    127
        Grade 3 Headache, Across doses (N=576)
    6
        Related Headache, Across doses (N=576)
    47
        Any Myalgia, Across doses (N=576)
    115
        Grade 3 Myalgia, Across doses (N=576)
    7
        Related Myalgia, Across doses (N=576)
    51
        Any Rash, Across doses (N=576)
    17
        Grade 3 Rash, Across doses (N=576)
    2
        Related Rash, Across doses (N=576)
    8
        Any Urticaria, Across doses (N=576)
    14
        Grade 3 Urticaria, Across doses (N=576)
    1
        Related Urticaria, Across doses (N=576)
    4
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects reporting any, Grade 3, related, and Grade 3 and related unsolicited adverse events (AEs) [3]
    End point description
    An 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigators as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigators as causally related to the study vaccination.
    End point type
    Primary
    End point timeframe
    During the 30-day (Days 0-29) post-vaccination period
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Cervarix Group
    Number of subjects analysed
    596
    Units: Subjects
        Any AE(s)
    20
        Grade 3 AE(s)
    3
        Related AE(s)
    2
        Grade 3 and Related AE(s)
    0
    No statistical analyses for this end point

    Primary: Number of subjects with any, Grade 3 and related serious adverse events (SAEs)

    		 Close Top of page
    End point title
    		 Number of subjects with any, Grade 3 and related serious adverse events (SAEs) [4]
    End point description
    SAEs assessed include 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. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
    End point type
    Primary
    End point timeframe
    During the entire study period (from Day 0 up to Month 7)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Cervarix Group
    Number of subjects analysed
    596
    Units: Subjects
        Any SAE(s)
    4
        Grade 3 SAE(s)
    1
        Related SAE(s)
    0
    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: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7)
    Adverse event reporting additional description
    For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.

    Serious adverse events
    		 Cervarix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 596 (0.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Mitral valve prolapse
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Typhoid fever
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cervarix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    443 / 596 (74.33%)
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    127 / 596 (21.31%)
         occurrences all number
    184
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    165 / 596 (27.68%)
         occurrences all number
    258
    Injection site erythema
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    430 / 596 (72.15%)
         occurrences all number
    922
    Pyrexia
         subjects affected / exposed
    32 / 596 (5.37%)
         occurrences all number
    42
    Swelling
         subjects affected / exposed
    119 / 596 (19.97%)
         occurrences all number
    183
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Gastrointestinal disorder
         subjects affected / exposed
    68 / 596 (11.41%)
         occurrences all number
    93
    Reproductive system and breast disorders
    Polycystic ovaries
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    4 / 596 (0.67%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    168 / 596 (28.19%)
         occurrences all number
    291
    Pruritus
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    17 / 596 (2.85%)
         occurrences all number
    20
    Urticaria
         subjects affected / exposed
    14 / 596 (2.35%)
         occurrences all number
    16
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    102 / 596 (17.11%)
         occurrences all number
    149
    Back pain
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    115 / 596 (19.30%)
         occurrences all number
    173
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    7 / 596 (1.17%)
         occurrences all number
    7
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 596 (0.34%)
         occurrences all number
    2
    Vaginitis bacterial
         subjects affected / exposed
    1 / 596 (0.17%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2008
    - The mandated telephone call to be done on Day 8 as a study procedure has been removed from relevant sections as the procedure was deemed as an extra obligation beyond the normal clinical practice for the investigators as per local customs. Instead, investigators have to emphasize to the subjects on the day of visit itself that they should monitor for AEs, complete their diary card, and return it at their next visit. - The indication/study population has been updated to reflect the indication in the approved PI. - The licensure of the Cervarix in the European Union has been added in Section 1.2 to provide updated information. - No blood samples were planned to be collected. In case an autoimmune disease is diagnosed during the study, autoantibody testing may be performed on blood samples collected (approximately 1mL), if agreed by the subject (see Section 8.4). - Changes were done to Section 4.2 to reflect updates in the protocol over versions 12.3, 12.4 and 12.5 related to adequate contraception for participation in the study. Section 5.2.1 has been added to include protocol version upgrades related to adequate contraception (SOP-WWD-0015). Section 6.6 (Concomitant medication/treatment) has also been updated to reflect changes from versions 12.3, 12.4 and 12.5. - The Clinical Research Associates (CRAs) contributing to authoring have been updated in the title page and the details of study contact for reporting SAEs have been updated accordingly.

    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-Fri Apr 26 01:28:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA