Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Papillomavirus

Treatments: Procedure: Blood sampling; Procedure: Liquid-based cytology (LBC) sampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT00929526

112949

Details and patient eligibility

About

This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic HPV types for an additional two years. All subjects who participated in the primary vaccination study NCT00316693 and who confirmed their interest in participating in a long term follow up study will therefore be invited to be followed for up to 48 months after administration of the first dose of vaccine. In addition, safety and persistence of the humoral immune response will be evaluated in this study.

This protocol posting deals with objectives & outcome measures of the extension phase at Months 36 and 48. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00316693).

Enrollment: 752 patients

Sex: Female

Ages: 20 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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752 participants in 2 patient groups, including a placebo group

Cervarix Group

Experimental group

Description:

subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.

Treatment:

Procedure: Blood sampling

Procedure: Liquid-based cytology (LBC) sampling

Aimmugen Group

Placebo Comparator group

Description:

subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.

Treatment:

Procedure: Liquid-based cytology (LBC) sampling