Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects

NCT ID: NCT00947115

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-22
• Study Completion Date: 2015-02-03

Brief Summary

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals with objectives & outcome measures of the extension phase from Year 5 to Year 10. The objectives & outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (NCT00196937).

Detailed Description

Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No vaccine was administered in this extension study.

Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.

Conditions

Infections, Papillomavirus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cervarix 15-25 years group

Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: PROCEDURE

Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.

Cervico-vaginal secretion (CVS) samples

Intervention Type: PROCEDURE

CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.

Cervarix 26-45 years group

Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: PROCEDURE

Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.

Cervico-vaginal secretion (CVS) samples

Intervention Type: PROCEDURE

CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.

Cervarix 46-55 years group

Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: PROCEDURE

Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.

Cervico-vaginal secretion (CVS) samples

Intervention Type: PROCEDURE

CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.

Interventions

Blood sampling

Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.

Intervention Type: PROCEDURE

Cervico-vaginal secretion (CVS) samples

CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believed that they could and would comply with the requirements of the protocol.
• A female who had been enrolled in NCT00196937 study and received three doses of HPV-16/18 vaccine.
• Written informed consent obtained from the subject.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
• Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
• 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 (pharmaceutical product or device).
• Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
• Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in NCT00196937 study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Poznan, , Poland

Countries

Germany; Poland

References

Schwarz T, Spaczynski M, Kaufmann A, Wysocki J, Galaj A, Schulze K, Suryakiran P, Thomas F, Descamps D. Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study. BJOG. 2015 Jan;122(1):107-18. doi: 10.1111/1471-0528.13070. Epub 2014 Sep 11.

Reference Type: BACKGROUND

PMID: 25208608 (View on PubMed)

Other Identifiers

2009-011357-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

112772

Identifier Type: -

Identifier Source: org_study_id