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Evaluation of Safety and Immunogenicity of Co-Administering HPV Vaccine With Other Vaccines in Healthy Female Subjects

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00426361
  Purpose

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/adolescents platform. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals' HPV-16/18 L1 AS04 vaccine (580299) as compared to the administration of either vaccine alone.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Papillomavirus Infections
Cervical Neoplasia
Biological: HPV-16/18 L1 AS04 (580299)
Biological: Boostrix Polio (dTpa-IPV)
Phase III

MedlinePlus related topics:   Cancer    Polio and Post-Polio Syndrome   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Multicentre Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) Co-Administered With Boostrix Polio (dTpa-IPV) in Healthy Female Subjects Aged 10-18 Years

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage of subjects with anti-D and anti-T antibody titres above the defined cut-off in all dTpa-IPV vaccine recipients [ Time Frame: One month after vaccination with dTpa-IPV ]
  • Anti-PT, anti-PRN and anti-FHA GMTs in all dTpa-IPV vaccine recipients [ Time Frame: One month after vaccination with dTpa-IPV ]
  • Percentage of subjects with anti-Polio type 1, anti-Polio type 2 and anti-Polio type 3 above the defined cut-off in all dTpa-IPV vaccine recipients [ Time Frame: One month after vaccination with dTpa-IPV ]

Secondary Outcome Measures:
  • Anti-HPV-16 and anti-HPV-18 seroconversion rates and GMTs in all HPV vaccine recipients [ Time Frame: One month post Dose 3 ]
  • Anti-HPV-16 and anti-HPV-18 seroconversion and GMTs in HPV and HPV+dTpa-IPV groups [ Time Frame: One month post Dose 1 ]
  • Anti-D and anti-T GMTs in all dTpa-IPV vaccine recipients [ Time Frame: One month after vaccination with dTpa-IPV ]
  • Percentage of subjects with anti-D and anti-T antibody titres above the defined cut-off in all dTpa-IPV vaccine recipients [ Time Frame: One month after vaccination with dTpa-IPV ]
  • Anti-polio type 1, 2 and 3 GMTs in all dTpa-IPV vaccine recipients [ Time Frame: One month after vaccination with dTpa-IPV ]
  • Booster responses for anti-D and anti-T in all dTpa-IPV vaccine recipients [ Time Frame: One month after vaccination with dTpa-IPV ]
  • Booster responses for anti-PT, anti-FHA and anti-PRN in all dTpa-IPV vaccine recipients [ Time Frame: One month after vaccination with dTpa-IPV ]
  • The occurrence and intensity of solicited local symptoms in all vaccine groups [ Time Frame: During the 7-day period (Day 0-6) following each and any vaccination ]
  • The occurrence, intensity and relationship to vaccination of solicited general symptoms in all vaccine groups [ Time Frame: During the 7-day period following each vaccination ]
  • The occurrence, intensity and relationship to vaccination of unsolicited AEs in all vaccine groups [ Time Frame: During the 30-day period following any vaccination ]
  • The nature, intensity and relationship to vaccination of SAEs in all groups [ Time Frame: Throughout the active phase of the study (up to Month 7 or Month 8) ]
  • The occurrence of NOCD and other medically significant conditions in all groups regardless of causal relationship to vaccination and intensity. [ Time Frame: Throughout the active phase of the study (up to Month 7 or Month 8) ]
  • The nature, intensity and relationship to vaccination of SAEs in all groups [ Time Frame: Throughout the safety follow-up (up to Month 12 or Month 13) ]
  • The occurrence of NOCD and other medically significant conditions in all groups regardless of causal relationship to vaccination and intensity. [ Time Frame: Throughout the safety follow-up (up to Month 12 or Month 13) ]

Estimated Enrollment:   750
Study Start Date:   February 2007
Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and their parents/legally acceptable representatives can, and will, comply with the requirements of the protocol should be enrolled in the study.
  • A female between, and including, 10 and 18 years of age at the time of the first vaccination.
  • Written informed consent/assent obtained from the subject prior to enrolment. For subjects above the legal age of consent, written informed consent must be obtained from the subject. For subjects below legal age of consent, written informed consent obtained from the subject's parent/LAR, and written informed assent must be obtained from the subject.
  • Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study.
  • Previously completed routine childhood vaccinations according to the recommended vaccination schedule at the time.
  • Subjects must have a negative urine pregnancy test.
  • Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study, and therefore become of childbearing potential, must agree to follow the same precautions.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12/13).
  • Concurrently participating in another clinical study, at any time during the study period, 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 up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
  • A woman 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
  • Administration of a diphtheria, tetanus, pertussis (DTP) vaccine, diphtheria-tetanus (Td) booster or dTpa vaccine within the previous five years.
  • Administration of a pre-school booster of OPV or IPV vaccine (4 or 5th dose) within the previous five years.
  • Hypersensitivity to latex.
  • Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality or thrombocytopenia, 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.
  • History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
  • Temperature of ≥40°C within 48 hours of receipt of a prior dose of DTP vaccine (DTPw and/or DTPa), not due to another identifiable cause.
  • Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine (DTPw and/or DTPa).
  • Seizures with or without fever within three days of a prior dose of DTP vaccine (DTPw and/or DTPa).
  • Persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours of a prior dose of DTP vaccine (DTPw and/or DTPa).
  • Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years.
  • Known exposure to diphtheria or household exposure to pertussis within 30 days before (i.e., Day 0-29) vaccination with dTpa-IPV.
  • Diphtheria and/or tetanus and/or pertussis and/or polio diagnosed within 30 days before (i.e., Day 0-29) vaccination with dTpa-IPV.
  • Presence of a contra-indication to vaccination according to the product leaflet of the commercially available dTpa-IPV vaccine.
  • 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 3 months preceding the first dose of study vaccine or planned administration during the study period. Enrolment will be postponed until the subject is outside the specified window.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426361

Locations
France
GSK Clinical Trials Call Center    
      Paris, France
Germany
GSK Clinical Trials Call Center    
      Berlin, Germany
Spain
GSK Clinical Trials Call Center    
      Madrid, Spain

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     Clinical Trials     GlaxoSmithKline    
  More Information


Responsible Party:   GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:   108464
First Received:   January 23, 2007
Last Updated:   September 22, 2008
ClinicalTrials.gov Identifier:   NCT00426361
Health Authority:   Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
HPV  
HPV-16/18 infections  

Study placed in the following topic categories:
Virus Diseases
Poliomyelitis
DNA Virus Infections
Papillomavirus Infections
Healthy

Additional relevant MeSH terms:
Tumor Virus Infections
Infection

ClinicalTrials.gov processed this record on September 23, 2008




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