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

Sponsored by:	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 580299 Biological: Engerix-B	Phase IV

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered in Healthy Adolescents.

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

Secondary Outcome Measures:

HPV-16 and/or HPV-18 DNA positivity in 18-19 year old female study participants
High-risk HPV DNA positivity in all 18-19 year old female study participants
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 ]
Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms in a subset of subjects. [ Time Frame: Within 30 days after any vaccination ]
Occurrence of rash and urticaria in a subset of subjects [ Time Frame: Within 30 minutes following vaccination ]
Occurrence of medically significant conditions in a subset of subjects [ Time Frame: From dose 1 until Month 12 ]
Occurrence and causal relationship to vaccination of SAEs in a subset of subjects [ Time Frame: From dose 1 until Month 12 ]
Occurrence of SAEs assessed by the investigator as possibly related to vaccination in all subjects [ Time Frame: Reported during the entire study period ]
Occurrence of new onset of autoimmune diseases retrieved from hospital discharge registry in all subjects [ Time Frame: Between Visit 1 and Visit 5 ]
Occurrence of pregnancies with onset, and their outcomes, retrieved from medical birth registry [ Time Frame: Between Visit 1 and Visit 5 ]
Occurrence of CIN3+, retrieved from Finnish Cancer Registry [ Time Frame: Between Visit 1 and Visit 5 ]
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 ]

Estimated Enrollment:	70000
Study Start Date:	October 2007
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

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

Show 72 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106636
Study First Received:	September 24, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00534638 History of Changes
Health Authority:	Finland: National Agency for Medicines

Keywords provided by GlaxoSmithKline:

HPV
cervical cancer
adolescents
Human papillomavirus (HPV vaccine)

Study placed in the following topic categories:

Healthy

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on May 07, 2009