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Trial record 45 of 91 for:    cervarix

Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

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ClinicalTrials.gov Identifier: NCT00578227
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : January 6, 2010
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE December 21, 2007
Results First Submitted Date  ICMJE November 27, 2009
Results First Posted Date  ICMJE January 6, 2010
Last Update Posted Date August 17, 2018
Study Start Date  ICMJE December 15, 2007
Actual Primary Completion Date December 1, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
  • Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies [ Time Frame: At Month 7 ]
    Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
  • Anti-Heptatis A (HAV) Antibody Titers. [ Time Frame: At Month 7 ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.
  • Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies [ Time Frame: At Month 7 ]
    A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
  • Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies [ Time Frame: At Month 7 ]
    Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
  • Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers [ Time Frame: At Month 7 ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • Anti-HAV seroconversion status in selected groups [ Time Frame: At Month 7 ]
  • Anti-HAV antibody titres in selected groups [ Time Frame: At Month 7 ]
  • Anti-HBs seroprotection status in selected groups [ Time Frame: At Month 7 ]
  • Anti-HPV-16/18 seroconversion status in selected groups [ Time Frame: At Month 7 ]
  • Anti-HPV-16/18 antibody titres in selected groups [ Time Frame: At Month 7 ]
Change History Complete list of historical versions of study NCT00578227 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
  • Anti-HBs Antibody Titers [ Time Frame: At Month 7 ]
    Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.
  • Number of Subjects Seroconverted for Anti-HBs Antibodies [ Time Frame: At month 7 ]
    Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.
  • Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years [ Time Frame: At Month 7 ]
    Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
  • Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years [ Time Frame: At Month 7 ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
  • Number of Subjects Seroconverted for Anti-HAV Antibodies [ Time Frame: One month after the second dose of vaccine ]
    Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
  • Anti-HAV Antibody Titers [ Time Frame: One month after the second dose of vaccine ]
    Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
  • Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies [ Time Frame: One month after the second dose of vaccine ]
    Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination. A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
  • Anti-HBs Antibody Titers [ Time Frame: One month after the second dose of vaccine ]
    Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
  • Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies [ Time Frame: One month after the second dose of vaccine ]
    Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
  • Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers [ Time Frame: One month after the second dose of vaccine ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 7-day period (Day 0-6) following vaccination ]
    Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.
  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 7-day period following vaccination ]
    Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, greater than or equal to 37.5 degree Celsius (°C)] and urticaria.
  • Number of Subjects Reporting Medically Significant Conditions [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
    Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
  • Number of Subjects Reporting Medically Significant Conditions [ Time Frame: Throughout the safety follow-up (from Month 7 up to Month 12) ]
    Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: During the 30-day period following any vaccination ]
    Unsolicited adverse events include any adverse event 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 Reporting Serious Adverse Events (SAE) [ Time Frame: Throughout the study (up to Month 12) ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • Anti-HBs antibody titres in selected groups [ Time Frame: At Month 7 ]
  • Anti-HBs seroconversion status in selected groups [ Time Frame: At month 7 ]
  • For all HPV-16/18 vaccine recipients aged 9 years, anti-HPV-16/18 seroconversion status [ Time Frame: At Month 7 ]
  • For all HPV-16/18 vaccine recipients aged 9 years, anti-HPV-16/18 antibody titres [ Time Frame: At Month 7 ]
  • Occurrence of any and Grade 3 solicited local symptoms in all study groups, overall in subjects aged 9-15 years and in subjects aged 9 years. [ Time Frame: During the 7-day period (Day 0-6) following each and any vaccination ]
  • Occurrence of any, Grade 3 and causally related to vaccination solicited general symptoms in all study groups, overall in subjects aged 9-15 years and in subjects aged 9 years. [ Time Frame: During the 7-day period following each vaccination ]
  • Occurrence of any Grade 3 and causally related to vaccination unsolicited adverse events in all study groups, overall in subjects aged 9-15 years and in subjects aged 9 years. [ Time Frame: During the 30-day period following any vaccination ]
  • Occurrence of any, Grade 3 and causally related to vaccination serious adverse events in all groups [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
  • Occurrence of any, Grade 3 and causally related to vaccination serious adverse events in all groups [ Time Frame: Throughout the safety follow-up (up to Month 12) ]
  • Occurrence of medically significant conditions in all groups throughout the active phase of the study regardless of causal relationship to vaccination and intensity. [ Time Frame: Up to Month 7 ]
  • Occurrence of medically significant conditions in all groups throughout the safety follow-up regardless of causal relationship to vaccination and intensity. [ Time Frame: Up to Month 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects
Official Title  ICMJE Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents
Brief Summary Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Infections, Papillomavirus
Intervention  ICMJE
  • Biological: Cervarix™
    Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
    Other Names:
    • HPV vaccine
    • GSK Biologicals' HPV-16/18 L1 AS04
  • Biological: Twinrix ™ Paediatric
    Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
Study Arms  ICMJE
  • Experimental: Cervarix™ & Twinrix™ Group
    Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
    Interventions:
    • Biological: Cervarix™
    • Biological: Twinrix ™ Paediatric
  • Experimental: Cervarix™ Group
    Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
    Intervention: Biological: Cervarix™
  • Active Comparator: Twinrix™ Group
    Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
    Intervention: Biological: Twinrix ™ Paediatric
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2010)
814
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2007)
810
Actual Study Completion Date  ICMJE April 28, 2009
Actual Primary Completion Date December 1, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their legally acceptable representatives (LARs) can and will comply with the requirements of the protocol should be enrolled in the study.
  • A female between, and including, 9 and 15 years of age (has not attained her 16th birthday) at the time of the first vaccination.
  • Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's LAR, and written informed assent must be obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects must not be pregnant.
  • Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or use adequate contraception for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

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 (up to Month 12).
  • Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • 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 each dose of vaccine(s). Administration of routine vaccines may be allowed up to 8 days before the first dose
  • A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
  • Pregnant or breastfeeding women.
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
  • Previous administration of components of the investigational vaccine.
  • Previous vaccination against hepatitis A or B planned administration of any hepatitis A or B vaccine other than that foreseen by the study protocol during the study period.
  • History of hepatitis A or B infection.
  • Known exposure to hepatitis A or B within the previous 6 weeks.
  • Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
  • Cancer or autoimmune disease under treatment.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 9 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Hungary,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00578227
Other Study ID Numbers  ICMJE 110886
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP