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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00534638

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 IV

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:

MedlinePlus related topics: Cancer Cervical Cancer

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

HPV-16 and/or HPV-18 DNA positivity in all 18 - 19 year old female study participants [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HPV-16 and/or HPV-18 DNA positivity in 18 - 19 year old female study participants [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
High-risk HPV DNA positivity in all 18 - 19 year old female study participants [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
Occurrence, intensity and causal relationship to vaccination of solicited (local and general) symptoms in a subset of subjects. [ Time Frame: Within 7 days after any vaccination ] [ Designated as safety issue: No ]
Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms in a subset of subjects. [ Time Frame: Within 30 days after any vaccination ] [ Designated as safety issue: No ]
Occurrence of rash and urticaria in a subset of subjects [ Time Frame: Within 30 minutes following vaccination ] [ Designated as safety issue: No ]
Occurrence of medically significant conditions in a subset of subjects [ Time Frame: From dose 1 until Month 12 ] [ Designated as safety issue: No ]
Occurrence and causal relationship to vaccination of SAEs in a subset of subjects [ Time Frame: From dose 1 until Month 12 ] [ Designated as safety issue: No ]
Occurrence of SAEs assessed by the investigator as possibly related to vaccination in all subjects [ Time Frame: Reported during the entire study period ] [ Designated as safety issue: No ]
Occurrence of new onset of autoimmune diseases retrieved from hospital discharge registry in all subjects [ Time Frame: Between Visit 1 and Visit 5 ] [ Designated as safety issue: No ]
Occurrence of pregnancies with onset, and their outcomes, retrieved from medical birth registry [ Time Frame: Between Visit 1 and Visit 5 ] [ Designated as safety issue: No ]
Occurrence of CIN3+, retrieved from Finnish Cancer Registry [ Time Frame: Between Visit 1 and Visit 5 ] [ Designated as safety issue: No ]
Anti-HPV-16/18 antibody levels and quality assessed at the time of serum withdrawal in a subset of subjects [ Time Frame: Visits 1, 4, and 5 ] [ Designated as safety issue: No ]

Estimated Enrollment:	68000
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A 90% of male and female adolescents will receive GSK Biologicals' HPV Vaccine GSK580299. Rest of the subjects will receive Engerix-B™ vaccine.	Biological: GSK Biologicals' HPV Vaccine GSK580299 Intramuscular injection, 3 doses Biological: Engerix-B™ Intramuscular injection, 3 doses
Experimental: Group B 90% of the female adolescents will receive GSK Biologicals' HPV Vaccine GSK580299. Male adolescents and rest of the female adolescents will receive Engerix-B™ vaccine.	Biological: GSK Biologicals' HPV Vaccine GSK580299 Intramuscular injection, 3 doses Biological: Engerix-B™ Intramuscular injection, 3 doses
Active Comparator: Group C All adolescents will receive Engerix-B™ vaccine.	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

Locations

Finland
GSK Investigational Site
Aanekoski, Finland, 44100
GSK Investigational Site
Hameenlinna, Finland, 13100
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Hyvinkaa, Finland, 05800
GSK Investigational Site
Iisalmi, Finland, 74100
GSK Investigational Site
Jamsa, Finland, 42100
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Joensuu, Finland, 80130
GSK Investigational Site
Jyvaskyla, Finland, 40100
GSK Investigational Site
Kajaani, Finland, 87100
GSK Investigational Site
Kemi, Finland, 94100
GSK Investigational Site
Kokkola, Finland, 67100
GSK Investigational Site
Kotka, Finland, 48100
GSK Investigational Site
Kouvola, Finland, 45100
GSK Investigational Site
Kuopio, Finland, 70100
GSK Investigational Site
Kuusamo, Finland, 93600
GSK Investigational Site
Lahti, Finland, 15110
GSK Investigational Site
Lappeenranta, Finland, 53100
GSK Investigational Site
Lohja, Finland, 08100
GSK Investigational Site
Mikkeli, Finland, 50100
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Pori, Finland, 28100
GSK Investigational Site
Porvoo, Finland, 06100
GSK Investigational Site
Rauma, Finland, 26100
GSK Investigational Site
Rovaniemi, Finland, 96100
GSK Investigational Site
Salo, Finland, 24100
GSK Investigational Site
Sastamala, Finland, 38200
GSK Investigational Site
Savonlinna, Finland, 57100
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20100
GSK Investigational Site
Vaasa, Finland, 65100
GSK Investigational Site
Varkaus, Finland, 78200

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00534638 History of Changes
Other Study ID Numbers:	106636
Study First Received:	September 24, 2007
Last Updated:	February 2, 2012
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by GlaxoSmithKline:

adolescents
cervical cancer
Human papillomavirus (HPV vaccine)
HPV

ClinicalTrials.gov processed this record on February 09, 2012