Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects

NCT ID: NCT00369824

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-26
• Study Completion Date: 2008-02-13

Brief Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase 3b study is designed to evaluate the safety and immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine (580299) as compared to the administration of any of the vaccines alone.

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 + Boostrix/Menactra Group

Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.

Group Type: EXPERIMENTAL

Different formulations of GSK Biologicals' HPV vaccine (580299)

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively

Menactra TM

Intervention Type: BIOLOGICAL

One dose of vaccine administered intramuscularly

Boostrix TM

Intervention Type: BIOLOGICAL

One dose of vaccine administered intramuscularly

Cervarix + Menactra/Boostrix Group

Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.

Group Type: EXPERIMENTAL

Different formulations of GSK Biologicals' HPV vaccine (580299)

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively

Menactra TM

Intervention Type: BIOLOGICAL

One dose of vaccine administered intramuscularly

Boostrix TM

Intervention Type: BIOLOGICAL

One dose of vaccine administered intramuscularly

Cervarix + Boostrix + Menactra Group

Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.

Group Type: EXPERIMENTAL

Different formulations of GSK Biologicals' HPV vaccine (580299)

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively

Menactra TM

Intervention Type: BIOLOGICAL

One dose of vaccine administered intramuscularly

Boostrix TM

Intervention Type: BIOLOGICAL

One dose of vaccine administered intramuscularly

Boostrix/Cervarix Group

Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.

Group Type: EXPERIMENTAL

Different formulations of GSK Biologicals' HPV vaccine (580299)

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively

Menactra TM

Intervention Type: BIOLOGICAL

One dose of vaccine administered intramuscularly

Boostrix TM

Intervention Type: BIOLOGICAL

One dose of vaccine administered intramuscularly

Menactra/Cervarix Group

Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.

Group Type: EXPERIMENTAL

Different formulations of GSK Biologicals' HPV vaccine (580299)

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively

Menactra TM

Intervention Type: BIOLOGICAL

One dose of vaccine administered intramuscularly

Cervarix Group

Subjects received Cervarix at Months 0, 1 and 6.

Group Type: EXPERIMENTAL

Different formulations of GSK Biologicals' HPV vaccine (580299)

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively

Interventions

Different formulations of GSK Biologicals' HPV vaccine (580299)

Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively

Intervention Type: BIOLOGICAL

Menactra TM

One dose of vaccine administered intramuscularly

Intervention Type: BIOLOGICAL

Boostrix TM

One dose of vaccine administered intramuscularly

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they can, and will, comply with the requirements of the protocol should be enrolled in the study.
• A female between, and including, 11 and 18 years of age at the time of the first vaccination.
• Written informed consent obtained from parents/legally acceptable representative of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject is 18 years of age.
• Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study.
• Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases, according to the recommended vaccination schedule at the time.
• Subjects must have a negative urine pregnancy test.
• Subjects of childbearing potential at the time of study entry are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects also are required to agree to continue such precautions for two months after completion of the vaccination series. Female subjects who reach menarche (began menstruating) during the study and therefore become of child-bearing potential are required to agree to follow the same precautions.

Exclusion Criteria

• 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.
• Concurrently participating in another clinical study, at any time during the study period (up to the Month 12/13 visit), in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
• A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
• Pregnant or breastfeeding women.
• 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
• Administration of a pre-school booster of diphtheria, tetanus, pertussis vaccine within the previous five years.
• Administration of a diphtheria-tetanus booster or tetanus-diphteria-acellular pertussis (Tdap) vaccine within the previous five years.
• Previous vaccination against Neisseria meningitidis.
• Hypersensitivity to latex.
• Cancer or autoimmune disease under treatment.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine.
• History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
• Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.
• Temperature of >= 105°F within 48 hours of receipt of a prior dose of diphteria- tetanu-pertussis (DTP) vaccine, not due to another identifiable cause.
• Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine.
• Seizures with or without fever within three days of a prior dose of DTP vaccine.
• Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years.
• Previous history of Guillain-Barré syndrome.
• Any confirmed or suspected immunosuppressive or immunodeficient condition
• Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 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

Mobile, Alabama, United States

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Madera, California, United States

GSK Investigational Site

Rolling Hills Estates, California, United States

GSK Investigational Site

Centennial, Colorado, United States

GSK Investigational Site

Golden, Colorado, United States

GSK Investigational Site

Thornton, Colorado, United States

GSK Investigational Site

Cocoa Beach, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Arkansas City, Kansas, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Bossier City, Louisiana, United States

GSK Investigational Site

Milford, Massachusetts, United States

GSK Investigational Site

Niles, Michigan, United States

GSK Investigational Site

Stevensville, Michigan, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Edison, New Jersey, United States

GSK Investigational Site

Whitehouse Station, New Jersey, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Cary, North Carolina, United States

GSK Investigational Site

Laurinburg, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Sylva, North Carolina, United States

GSK Investigational Site

Akron, Ohio, United States

GSK Investigational Site

Boardman, Ohio, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Greenville, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Uniontown, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Gray, Tennessee, United States

GSK Investigational Site

San Angelo, Texas, United States

GSK Investigational Site

Burke, Virginia, United States

GSK Investigational Site

Vienna, Virginia, United States

Countries

United States

References

Wheeler CM, Harvey BM, Pichichero ME, Simon MW, Combs SP, Blatter MM, Marshall GS, Catteau G, Dobbelaere K, Descamps D, Dubin G, Schuind A. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine coadministered with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine and/or meningococcal conjugate vaccine to healthy girls 11 to 18 years of age: results from a randomized open trial. Pediatr Infect Dis J. 2011 Dec;30(12):e225-34. doi: 10.1097/INF.0b013e31822d28df.

Reference Type: DERIVED

PMID: 21817954 (View on PubMed)

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: 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

Document Type: Study Protocol

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: 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

107682

Identifier Type: -

Identifier Source: org_study_id