Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

NCT ID: NCT00359619

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 383 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-12
• Study Completion Date: 2007-01-30

Brief Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.

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

Conditions

Infections, Papillomavirus; Papillomavirus Vaccines

Study Design

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

Study Groups

Cervarix Group

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: ACTIVE_COMPARATOR

CervarixTM

Intervention Type: BIOLOGICAL

Subjects were administered three doses of HPV vaccine

Cervarix 1 Group

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

HPV investigational vaccine GSK568893A, different formulations

Intervention Type: BIOLOGICAL

Subjects were administered three doses of HPV investigational vaccine

Cervarix 2 Group

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

HPV investigational vaccine GSK568893A, different formulations

Intervention Type: BIOLOGICAL

Subjects were administered three doses of HPV investigational vaccine

Cervarix 3 Group

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

HPV investigational vaccine GSK568893A, different formulations

Intervention Type: BIOLOGICAL

Subjects were administered three doses of HPV investigational vaccine

Cervarix 4 Group

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

HPV investigational vaccine GSK568893A, different formulations

Intervention Type: BIOLOGICAL

Subjects were administered three doses of HPV investigational vaccine

Cervarix 5 Group

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

HPV investigational vaccine GSK568893A, different formulations

Intervention Type: BIOLOGICAL

Subjects were administered three doses of HPV investigational vaccine

Cervarix 6 Group

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

HPV investigational vaccine GSK568893A, different formulations

Intervention Type: BIOLOGICAL

Subjects were administered three doses of HPV investigational vaccine

Interventions

CervarixTM

Subjects were administered three doses of HPV vaccine

Intervention Type: BIOLOGICAL

HPV investigational vaccine GSK568893A, different formulations

Subjects were administered three doses of HPV investigational vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A female who enrolled in the study 102115 and received three doses of vaccine.
• Written informed consent obtained from the subject prior to enrolment.

Exclusion Criteria

• Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
• Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
• Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
• Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.

• Minimum Eligible Age: 18 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

Denver, Colorado, United States

GSK Investigational Site

Golden, Colorado, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Liège, , Belgium

GSK Investigational Site

Tienen, , Belgium

GSK Investigational Site

Wilrijk, , Belgium

Countries

United States; Belgium

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: Study Protocol

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: Informed Consent Form

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

107919

Identifier Type: OTHER

Identifier Source: secondary_id

107921

Identifier Type: OTHER

Identifier Source: secondary_id

107918

Identifier Type: OTHER

Identifier Source: secondary_id

2004-003766-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

108052 (FU month 18)

Identifier Type: -

Identifier Source: org_study_id

NCT00359502

Identifier Type: -

Identifier Source: nct_alias

NCT00359528

Identifier Type: -

Identifier Source: nct_alias

NCT00359827

Identifier Type: -

Identifier Source: nct_alias