Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America

NCT ID: NCT00546078

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-14
• Study Completion Date: 2009-12-01

Brief Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed in the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Papillomavirus

Study Design

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

Study Groups

Cervarix™ 4-Dose Group

Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.

Group Type: EXPERIMENTAL

Cervarix™

Intervention Type: BIOLOGICAL

Intramuscular injection, one or three doses

Cervarix™ 3-Dose Group

Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.

Group Type: EXPERIMENTAL

Cervarix™

Intervention Type: BIOLOGICAL

Intramuscular injection, one or three doses

Interventions

Cervarix™

Intramuscular injection, one or three doses

Intervention Type: BIOLOGICAL

Other Intervention Names

GSK Biologicals' HPV Vaccine GSK580299

Eligibility Criteria

Inclusion Criteria

• A subject whom the investigator believes that she can and will comply with the requirements of the protocol
• Must have received three doses of study vaccine or placebo control in study 580299/001.
• Must have completed study 580299/007.
• Written informed consent must be obtained from the subject prior to enrollment in the study.
• Healthy subjects, as established by medical history and history-directed clinical examination before entering into the study.
• Subject must have a negative urine pregnancy test.
• Subject must be at least three months post-termination of a pregnancy.
• Subject must be of non-childbearing potential,or subjects are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects are also required to agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria

• Pregnant or breastfeeding.
• A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study until approximately 2 months after the last vaccination.
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed.
• Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
• previous administration of components of the investigational vaccine outside of protocol 580299/001.
• Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines,
• Hypersensitivity to latex
• Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Cancer or autoimmune disease under treatment.
• Administration of immunoglobulins and/or any blood products within the three months (90 days) preceding enrollment or planned administration during the study period.
• Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness
• Heavy bleeding or heavy vaginal discharge in which a pelvic exam cannot be performed.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 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

San Francisco, California, United States

GSK Investigational Site

Augusta, Georgia, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Grove City, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Marshfield, Wisconsin, United States

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Langley, British Columbia, Canada

GSK Investigational Site

Winnipeg, Manitoba, Canada

GSK Investigational Site

Toronto, Ontario, Canada

Countries

United States; Canada

References

Moscicki AB, Wheeler CM, Romanowski B, Hedrick J, Gall S, Ferris D, Poncelet S, Zahaf T, Moris P, Geeraerts B, Descamps D, Schuind A. Immune responses elicited by a fourth dose of the HPV-16/18 AS04-adjuvanted vaccine in previously vaccinated adult women. Vaccine. 2012 Dec 17;31(1):234-41. doi: 10.1016/j.vaccine.2012.09.037. Epub 2012 Oct 11.

Reference Type: BACKGROUND

PMID: 23063422 (View on PubMed)

Moscicki B et al. Anamnestic response elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.

Reference Type: BACKGROUND

Moscicki B et al. Anamnestic response to non-vaccine types elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.

Reference Type: BACKGROUND

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

109628

Identifier Type: -

Identifier Source: org_study_id