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Long-term Extension Study of the Efficacy of the 580299 Vaccine in the Prevention of HPV-16 and/or HPV-18 Associated Cervical Intraepithelial Neoplasia (CIN) in Japanese Women Vaccinated in the Primary Vaccination Study NCT00316693


Phase 3
20 Years
25 Years
Not Enrolling
Female
Human Papillomavirus Infection

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Trial Information

Long-term Extension Study of the Efficacy of the 580299 Vaccine in the Prevention of HPV-16 and/or HPV-18 Associated Cervical Intraepithelial Neoplasia (CIN) in Japanese Women Vaccinated in the Primary Vaccination Study NCT00316693


Inclusion Criteria:



- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol;

- Written informed consent obtained from the subject prior to enrolment in the
extension study;

- A subject previously vaccinated in the NCT00316693 study.

- Subjects who showed, at the last NCT00316693 study visit (at Month 24) willingness to
participate in this extension study.

Exclusion Criteria:

- Use of any HPV vaccine other than the one administered in the NCT00316693 study;

- Use of any investigational or non-registered product other than the study vaccine
since last NCT00316693 study visit, or planned use during the study period;

- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product;

- Subjects who were diagnosed high grade or missing cytology at Month 0 in the
NCT00316693 study;

- Pregnant females and females who were pregnant less than 3 months ago.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.

Outcome Description:

Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC). Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR). For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.

Outcome Time Frame:

From Month 0 up to Month 12

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

112949

NCT ID:

NCT00929526

Start Date:

June 2009

Completion Date:

February 2011

Related Keywords:

  • Human Papillomavirus Infection
  • HPV vaccine
  • cervical intraepithelial neoplasia (CIN)
  • including new onset of autoimmune disease [NOAD])
  • new onset of chronic disease (NOCD)
  • medically significant condition (MSC)
  • Cervical Intraepithelial Neoplasia
  • Warts
  • Papillomavirus Infections

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