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Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents


Phase 4
12 Years
15 Years
Open (Enrolling)
Both
Human Papillomavirus (HPV) Infection

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Trial Information

Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

HPV-16 and/or HPV-18 DNA positivity in all 18 - 19 year old female study participants

Outcome Time Frame:

At the time of analysis

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Finland: Finnish Medicines Agency

Study ID:

106636

NCT ID:

NCT00534638

Start Date:

October 2007

Completion Date:

June 2014

Related Keywords:

  • Human Papillomavirus (HPV) Infection
  • adolescents
  • cervical cancer
  • Human papillomavirus (HPV vaccine)
  • HPV

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