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

NCT00359619 | Completed Phase 2 Results

• 5 other identifiers: 108052 (FU month 18)1079191079211079182004-003766-14
• Study Type: interventional
• Target: 383
• Locations: 2 countries
• Sites: 10

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

Keywords

HPV vaccine

Outcome Measures

Primary Outcomes (6)

• Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.

  Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).

  At Months 18, 24, 36 and 48.

• Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.

  Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.

  At Months 18, 24, 36 and 48.

• Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies

  Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.

  At Months 18, 24, 36 and 48.

• Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.

  Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.

  At Months 18, 24, 36 and 48.

• Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.

  Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.

  At Months 18, 24, 36 and 48.

• Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies

  Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.

  At Months 18, 24, 36 and 48.

Secondary Outcomes (11)

• Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.

  At Months 18, 24, 36 and 48.

• Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.

  At Months 18, 24, 36 and 48.

• Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.

  At Months 18, 24, 36 and 48.

• Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.

  At Months 18, 24, 36 and 48.

• Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)

  From Month 0 to Months 18, 24, 36 and 48

Study Arms (7)

Cervarix Group

ACTIVE COMPARATOR

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.

Biological: CervarixTM

Cervarix 1 Group

EXPERIMENTAL

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.

Biological: HPV investigational vaccine GSK568893A, different formulations

Cervarix 2 Group

EXPERIMENTAL

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.

Biological: HPV investigational vaccine GSK568893A, different formulations

Cervarix 3 Group

EXPERIMENTAL

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.

Biological: HPV investigational vaccine GSK568893A, different formulations

Cervarix 4 Group

EXPERIMENTAL

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.

Biological: HPV investigational vaccine GSK568893A, different formulations

Cervarix 5 Group

EXPERIMENTAL

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.

Biological: HPV investigational vaccine GSK568893A, different formulations

Cervarix 6 Group

EXPERIMENTAL

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.

Biological: HPV investigational vaccine GSK568893A, different formulations

Interventions

CervarixTM BIOLOGICAL

Subjects were administered three doses of HPV vaccine

Cervarix Group

HPV investigational vaccine GSK568893A, different formulations BIOLOGICAL

Subjects were administered three doses of HPV investigational vaccine

Cervarix 1 Group; Cervarix 2 Group; Cervarix 3 Group; Cervarix 4 Group; Cervarix 5 Group; Cervarix 6 Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Denver, Colorado, 80262, United States

Location

GSK Investigational Site

Golden, Colorado, 80401, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84109, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84121, United States

Location

GSK Investigational Site

Brussels, 1070, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Tienen, 3300, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: August 2, 2006
• Study Start: September 12, 2006
• Primary Completion: January 30, 2007
• Study Completion: January 30, 2007
• Last Updated: January 2, 2020
• Results First Posted: February 10, 2015

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (4); BE (6)