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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00534638
• Date of registration: 24/09/2007
• Primary sponsor: GlaxoSmithKline
• Public title: Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents
• Scientific title: Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents
• Date of first enrolment: October 2007
• Target sample size: 68000
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00534638
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Finland

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: 15 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Human Papillomavirus (HPV) Infection

Intervention(s)

Biological: Engerix-B™

Biological: GSK Biologicals' HPV Vaccine GSK580299

Primary Outcome(s)

HPV-16 and/or HPV-18 DNA positivity in all 18 - 19 year old female study participants [Time Frame: At the time of analysis]

Secondary Outcome(s)

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]

High-risk HPV DNA positivity in all 18 - 19 year old female study participants [Time Frame: At the time of analysis]

HPV-16 and/or HPV-18 DNA positivity in 18 - 19 year old female study participants [Time Frame: At the time of analysis]

Occurrence and causal relationship to vaccination of SAEs in a subset of subjects [Time Frame: From dose 1 until Month 12]

Occurrence of CIN3+, retrieved from Finnish Cancer Registry [Time Frame: Between Visit 1 and Visit 5]

Occurrence of medically significant conditions in a subset of subjects [Time Frame: From dose 1 until Month 12]

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 rash and urticaria in a subset of subjects [Time Frame: Within 30 minutes following vaccination]

Occurrence of SAEs assessed by the investigator as possibly related to vaccination in all subjects [Time Frame: Reported during the entire study period]

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]

Secondary ID(s)

106636

Source(s) of Monetary Support

Please refer to primary and secondary sponsors