Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00779766
First received: October 23, 2008
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

This is a multicenter study in which women are planned to receive either the HPV vaccine or control. Study participation will last approximately 48 months and involves a total of eleven scheduled visits.

The Protocol Posting has been updated as the study will be extended by 2 additional years.


Condition Intervention Phase
Infections, Papillomavirus
Biological: HPV GSK 580299 vaccine
Biological: Placebo control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer.

    Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at Months 0 and 6 and seronegative at Month 0 or on subjects DNA- at Months 0 and 6, regardless of initial serostatus.



Secondary Outcome Measures:
  • Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered.

    • DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA)
    • Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.

  • Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months.

    Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.


  • Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months.

    Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA).

    Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.


  • Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.

    HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68


  • Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.

    HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68


  • Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.

    HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68


  • Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.

    US).


  • Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).

    Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.

    HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68


  • Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer.

    DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.


  • Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.

  • Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.

    HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68


  • Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.

    HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68


  • Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies [ Time Frame: at Months 0, 7, 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status [ Time Frame: at Months 0 and 7 ] [ Designated as safety issue: No ]
    HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.

  • Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status [ Time Frame: at Months 0 and 7 ] [ Designated as safety issue: No ]
    HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.

  • Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status [ Time Frame: at Months 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status [ Time Frame: at Months 0 and 7 ] [ Designated as safety issue: No ]

    Titers were expressed as geometric mean titers calculated on all subjects HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL).

    Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above the assay cut-off value prior to vaccination.


  • Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status [ Time Frame: at Months 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms [ Time Frame: Within 7 days (Days 0-6) after vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Swelling = swelling above 50 millimeter All local symptoms were considered as related to the study vaccination

  • Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. [ Time Frame: Within 7 days (Days 0-6) after vaccination ] [ Designated as safety issue: No ]

    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius).

    Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = prevented normal activity Grade 3 urticaria = distributed on at least 4 body areas


  • Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity. [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

  • Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status [ Time Frame: at Months 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity Overall and Stratified According to Month 0 HPV-16 or HPV-18 Serostatus and DNA Status. [ Time Frame: Throughout the study period (up to Month 48) ] [ Designated as safety issue: No ]
  • Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs) [ Time Frame: Within Days 0-29 after vaccination ] [ Designated as safety issue: No ]

    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

    Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity


  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  • Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline [ Time Frame: Within 7 days (Days 0-6) after vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination

  • Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: Within 7 days (Days 0-6) after vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity All local symptoms were considered as related to the study vaccination

  • Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: Within 7 days (Days 0-6) after vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination

  • Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline [ Time Frame: Within 7 days (Days 0-6) after vaccination ] [ Designated as safety issue: No ]

    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).

    Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity


  • Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: Within 7 days (Days 0-6) after vaccination ] [ Designated as safety issue: No ]

    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).

    Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed 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


  • Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: Within 7 days (Days 0-6) after vaccination ] [ Designated as safety issue: No ]

    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).

    Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed 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


  • Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline. [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

  • Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

  • Number (%) of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

  • Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline [ Time Frame: Within Days 0-29 after vaccination ] [ Designated as safety issue: No ]
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

  • Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: Within Days 0-29 after vaccination ] [ Designated as safety issue: No ]
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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

  • Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: Within Days 0-29 after vaccination ] [ Designated as safety issue: No ]
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

  • Number of Subjects With Any and Related to Vaccination Serious Adverse Events (SAEs) Overall and Stratified According to Month 0 HPV-16 or HPV-18 Serostatus and DNA Status. [ Time Frame: Throughout the study period (up to Month 48). ] [ Designated as safety issue: No ]
  • Number of Subjects With Serious Adverse Events (SAEs) for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  • Number of Subjects With Serious Adverse Events (SAEs) for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  • Number of Subjects With Serious Adverse Events (SAEs) for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  • Number of Subjects With Pregnancies and Their Outcomes Overall and Stratified According to Month 0 HPV-16 or HPV-18 Serostatus and DNA Status. [ Time Frame: Throughout the study period (up to Month 48) ] [ Designated as safety issue: No ]
  • Number of Subjects With Pregnancies and Their Outcomes [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]

    Outcomes of pregnancies were Live infant NO ACA, Premature live infant NO ACA, Elective termination NO ACA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth congenital anomaly, Lost to follow up, Molar pregnancy and Pregnancy ongoing.

    For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).


  • Number of Subjects With Pregnancies and Their Outcomes for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    Outcomes of pregnancies were Live infant NO ACA, Premature live infant NO ACA, Elective termination NO ACA, Elective termination CA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).

  • Number of Subjects With Pregnancies and Their Outcomes Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    Outcomes of pregnancies were Live infant NO ACA, Live infant CA, Premature live infant NO ACA, Elective termination NO ACA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).

  • Number of Subjects With Pregnancies and Their Outcomes for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline [ Time Frame: up to Month 24 ] [ Designated as safety issue: No ]
    Outcomes of pregnancies were Live infant NO ACA, Live infant CA, Premature live infant NO ACA, Elective termination NO ACA, Elective termination CA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).


Enrollment: 6051
Study Start Date: October 2008
Estimated Study Completion Date: January 2016
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix Group
Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Biological: HPV GSK 580299 vaccine
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Placebo Comparator: Placebo Group
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Biological: Placebo control
Subjects were planned to receive three doses of the placebo control administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Detailed Description:

This Protocol Posting has been updated following Protocol Amendment 2 28th March 2011.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Chinese females between and including 18 and 25 years of age at the time of the first vaccination.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject prior to enrolment.
  • Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
  • Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test.
  • Subjects must be of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination and agree to continue such precautions for 2 months after completion of the vaccination series.
  • Subject must have one single intact cervix.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e., Days 0-29) the first dose of vaccine.
  • Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
  • Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period.
  • Previous administration of components of the investigational vaccine.
  • History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
  • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779766

Locations
China, Jiangsu
GSK Investigational Site
Jintan, Jiangsu, China, 213200
GSK Investigational Site
Lianshui, Jiangsu, China
GSK Investigational Site
Xuzhou, Jiangsu, China, 221006
GSK Investigational Site
Yancheng, Jiangsu, China, 224500
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00779766     History of Changes
Other Study ID Numbers: 107638
Study First Received: October 23, 2008
Results First Received: April 12, 2012
Last Updated: April 17, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Human papillomavirus
vaccine
cervical cancer
cervical infection

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on September 16, 2014