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Completed

NCT Number: NCT00290277

Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.

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Key information

Conditions

Infections, Papillomavirus Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

10 year–14 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Daegu, South Korea

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About this study

Study participants will receive either HPV or hepatitis A vaccine, study duration will last for 7 months and involve a total of 4 visits.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A female subject between, and including, 10 and 14 years of age at the time of the first vaccination.
  • Written informed assent from the subject and informed consent from the parent or guardian of the subject should be obtained prior to enrolment.
  • Subjects must have a negative urine pregnancy test.
  • Healthy subject before entering the study as established by medical history and clinical examination.
  • Subject must be of non-childbearing potential.

Exclusion criteria

  • Pregnant or breastfeeding.
  • Previous vaccination against HPV.
  • Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality
  • History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease."

Treatment and study plan

HPV-16/18 L1/AS04

Biological

Primary outcomes

  1. To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.

Secondary outcomes

  1. To evaluate safety and reactogenicity throughout the study period.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs

Important dates

Study start
2005
Study completion
2006
First posted
Feb 13, 2006
Registry last updated
Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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