Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents

This study is currently recruiting participants.
Verified March 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00534638
First received: September 24, 2007
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and women. The most important disease associated with oncogenic HPV infection is cervical cancer, currently the second leading cause of cancer-related death among women globally.The current study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15 years of age.

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


Condition Intervention Phase
Human Papillomavirus (HPV) Infection
Biological: GSK Biologicals' HPV Vaccine GSK580299
Biological: Engerix-B™
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Genital Human papillomavirus 16 and/or 18 (HPV-16 and/or HPV-18) deoxyribonucleic acid (DNA) positivity (by polymerase chain reaction [PCR]) in females approximately 18.5 years of age in Cervarix/Engerix-B B Group versus Engerix-B Group. [ Time Frame: At the time of visit 5 (at 18.5 years of age) ] [ Designated as safety issue: No ]
  • Genital HPV-16 and/or HPV-18 DNA positivity (by PCR) in females approximately 18.5 years of age in Cervarix/Engerix-B A Group versus Engerix-B Group. [ Time Frame: At the time of visit 5 (at 18.5 years of age) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Genital HPV-16 and/or HPV-18 DNA positivity (by PCR) in females approximately 18.5 years of age in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B Group. [ Time Frame: At the time of visit 5 (at 18.5 years of age) ] [ Designated as safety issue: No ]
  • Genital oncogenic HPV DNA positivity (by PCR) (overall and individually) in females approximately 18.5 years of age. [ Time Frame: At the time of visit 5 (at 18.5 years of age) ] [ Designated as safety issue: No ]
  • Number of subjects reporting any and severe (Grade 3) solicited local symptoms, in a subset of subjects. [ Time Frame: Within 7 days (Days 0 - 6) after any vaccination ] [ Designated as safety issue: No ]
  • Number of subjects reporting any, severe (Grade 3) and related to vaccination solicited general symptoms, in a subset of subjects. [ Time Frame: Within 7 days (Days 0 - 6) after any vaccination ] [ Designated as safety issue: No ]
  • Number of subjects reporting any, severe (Grade 3) and related to vaccination unsolicited adverse events (AEs), in a subset of subjects. [ Time Frame: Within 30 days (Days 0 - 29) after any vaccination ] [ Designated as safety issue: No ]
  • Number of subjects reporting rash and urticaria, in a subset of subjects. [ Time Frame: Within 30 minutes following vaccination ] [ Designated as safety issue: No ]
  • Number of subjects reporting medically significant conditions (MSCs), in a subset of subjects. [ Time Frame: From Dose 1 (at Day 0) until Month 12 (phone contact) ] [ Designated as safety issue: No ]
  • Number of subjects reporting any serious adverse events (SAEs) and SAEs causally related to vaccination, in a subset of subjects [ Time Frame: From Dose 1 (at Day 0) until Month 12 ] [ Designated as safety issue: No ]
  • Number of subjects reporting SAEs assessed by the investigator as possibly related to vaccination. [ Time Frame: During the entire study period up to the Visit 5 (18.5 years of age) ] [ Designated as safety issue: No ]
  • Number of subjects reporting new onset of autoimmune diseases (NOADs). [ Time Frame: Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age) ] [ Designated as safety issue: No ]
  • Number of subjects reporting pregnancies with onset and their outcomes. [ Time Frame: Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age) ] [ Designated as safety issue: No ]
  • Number of subjects with HPV-16 and HPV-18 antibodies titres equal to or above the cut-off values, by gender, in a subset of subjects. [ Time Frame: At the time of visits 1 and 4 (at Day 0 and Month 7) ] [ Designated as safety issue: No ]

    The antibody titres against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 enzyme-linked immunosorbent assay units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.

    The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.


  • Number of subjects with HPV-16 and HPV-18 antibodies titres equal to or above the cut-off values, by gender, in a subset of subjects. [ Time Frame: At the time of Visit 5 (at 18.5 years of age) ] [ Designated as safety issue: No ]
  • Titres for anti-HPV-16 and anti-HPV-18 antibodies, by gender, in a subset of subjects. [ Time Frame: At the time of visits 1 and 4 (at Day 0 and Month 7) ] [ Designated as safety issue: No ]

    Titres were expressed as geometric mean antibody titres (GMTs) and were given in EL.U/mL.

    The antibody titres against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.

    The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.


  • Titres for anti-HPV-16 and anti-HPV-18 antibodies, by gender, in a subset of subjects. [ Time Frame: At the time of Visit 5 (at 18.5 years of age) ] [ Designated as safety issue: No ]

Estimated Enrollment: 36000
Study Start Date: October 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix/Engerix-B A Group
90% of male and female adolescents received Cervarix™ vaccine. Rest of the subjects received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Biological: GSK Biologicals' HPV Vaccine GSK580299
Intramuscular injection, 3 doses
Biological: Engerix-B™
Intramuscular injection, 3 doses
Experimental: Cervarix/Engerix-B B Group
90% of the female adolescents received Cervarix™ vaccine. Male adolescents and rest of the female adolescents received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Biological: GSK Biologicals' HPV Vaccine GSK580299
Intramuscular injection, 3 doses
Biological: Engerix-B™
Intramuscular injection, 3 doses
Active Comparator: Engerix-B Group
All adolescents were vaccinated with Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Biological: Engerix-B™
Intramuscular injection, 3 doses

Detailed Description:

As GSK Biologicals' HPV vaccine GSK580299 is not licensed for use in boys, the boys included in the current study and receiving the HPV vaccine are considered to be part of a Phase 3 trial. The study is partially blinded as some study participants will be aware of their group allocation but blinded to their treatment allocation. Overall, the study will be open.

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study participants who the investigator or delegate believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 12 and 15 years of age at the time of the first vaccination.
  • A written informed assent must be obtained from all study participants prior to enrolment. In addition, a written informed consent must be obtained from the study participants' parent or legally acceptable representative.
  • Healthy male and female study participants as established by medical history before entering into the study.
  • Study participants must not be pregnant. Absence of pregnancy should be verified as per investigator's or delegate's clinical judgement.
  • If the study participant is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Previous vaccination against HPV or Hepatitis B virus.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534638

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Finland
GSK Investigational Site Recruiting
Aanekoski, Finland, 44100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hameenlinna, Finland, 13100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Helsinki, Finland, 00100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hyvinkaa, Finland, 05800
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Iisalmi, Finland, 74100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Jamsa, Finland, 42100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Jarvenpaa, Finland, 04400
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Joensuu, Finland, 80130
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Jyvaskyla, Finland, 40100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Kajaani, Finland, 87100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Kemi, Finland, 94100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Kokkola, Finland, 67100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Kotka, Finland, 48100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Kouvola, Finland, 45100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Kuopio, Finland, 70100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Kuusamo, Finland, 93600
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Lahti, Finland, 15110
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Lappeenranta, Finland, 53100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Lohja, Finland, 08100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Mikkeli, Finland, 50100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Oulu, Finland, 90220
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Pori, Finland, 28100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Porvoo, Finland, 06100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Rauma, Finland, 26100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Rovaniemi, Finland, 96100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Salo, Finland, 24100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Sastamala, Finland, 38200
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Savonlinna, Finland, 57100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Seinajoki, Finland, 60100
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Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Tampere, Finland, 33100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Turku, Finland, 20100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Vaasa, Finland, 65100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Varkaus, Finland, 78200
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00534638     History of Changes
Other Study ID Numbers: 106636
Study First Received: September 24, 2007
Last Updated: March 6, 2014
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by GlaxoSmithKline:
adolescents
cervical cancer
Human papillomavirus (HPV vaccine)
HPV

ClinicalTrials.gov processed this record on April 17, 2014