Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US

NCT00799825 | Completed Phase 3 Results

• 1 other identifier: 111955
• Study Type: interventional
• Target: 346
• Locations: 2 countries
• Sites: 48

Brief Summary

This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 580299/008 and received the control vaccine (Hepatitis A vaccine).

Conditions

Infections, Papillomavirus

Keywords

papillomavirus; HPV vaccine; cervical cancer; HPV; human papillomavirus

Outcome Measures

Primary Outcomes (3)

• Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)

  SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.

  Throughout the study (up to Month 12)

• Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)

  MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.

  Throughout the study (up to Month 12)

• Number of Subjects With Pregnancies and Pregnancy Outcomes.

  Throughout the study (up to Month 12)

Study Arms (1)

Cervarix group

EXPERIMENTAL

Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.

Biological: GSK Biological's HPV vaccine GSK580299 (Cervarix™)

Interventions

GSK Biological's HPV vaccine GSK580299 (Cervarix™) BIOLOGICAL

All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.

Also known as: CervarixTM

Cervarix group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study
• A subject previously enrolled in the primary study (NCT00122681), who received the active control hepatitis A vaccine, and who cannot receive commercially available HPV-16/18 L1 VLP AS04 vaccine because the vaccine has not yet been granted licensure in the subject's country or because the subject is above the age for which the vaccine is licensed.
• Written informed consent must be obtained from the subject prior to enrolment.
• A woman aged 18 years or older, at the time of the first vaccination in this study.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects must not be pregnant. Absence of pregnancy should be verified with a urine pregnancy test.
• Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

You may not qualify if:

• Pregnant or lactating female. Enrolment should be deferred until three months after pregnancy has been completed or after lactating has ceased.
• A woman planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the extended safety follow-up period.
• 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 non-investigational product (pharmaceutical product or device).
• Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen by protocol.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days (i.e. Day 0-29) of each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
• Previous administration of components of the investigational vaccine.
• History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
• Hypersensitivity to latex.
• Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests, which in the opinion of the investigator precludes administration of the study vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Cancer or autoimmune disease under treatment.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Acute disease at the time of enrolment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (48)

GSK Investigational Site

San Diego, California, 92108, United States

Location

GSK Investigational Site

San Francisco, California, 94115, United States

Location

GSK Investigational Site

Denver, Colorado, 80218, United States

Location

GSK Investigational Site

Louisville, Colorado, 80027, United States

Location

GSK Investigational Site

Clearwater, Florida, 33759, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Augusta, Georgia, 30912-3500, United States

Location

GSK Investigational Site

Honolulu, Hawaii, 96826, United States

Location

GSK Investigational Site

Iowa City, Iowa, 52242, United States

Location

GSK Investigational Site

Arkansas City, Kansas, 67005, United States

Location

GSK Investigational Site

Newton, Kansas, 67114, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Bardstown, Kentucky, 40004, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55455, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68131, United States

Location

GSK Investigational Site

Lebanon, New Hampshire, 03756, United States

Location

GSK Investigational Site

Morristown, New Jersey, 07962, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87131, United States

Location

GSK Investigational Site

New York, New York, 10029, United States

Location

GSK Investigational Site

Poughkeepsie, New York, 12601, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27514, United States

Location

GSK Investigational Site

New Bern, North Carolina, 28562, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44109, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74105, United States

Location

GSK Investigational Site

Portland, Oregon, 97210, United States

Location

GSK Investigational Site

Carnegie, Pennsylvania, 15106, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16507, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16508, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19114, United States

Location

GSK Investigational Site

Pleasant Hills, Pennsylvania, 15236, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Webster, Texas, 77598, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22903, United States

Location

GSK Investigational Site

Spokane, Washington, 99202, United States

Location

GSK Investigational Site

Wenatchee, Washington, 98801, United States

Location

GSK Investigational Site

Edmonton, Alberta, T6G 2C8, Canada

Location

GSK Investigational Site

Langley, British Columbia, V3A 4H9, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3E 0J9, Canada

Location

GSK Investigational Site

St. John's, Newfoundland and Labrador, A1E 2C2, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Waterloo, Ontario, N2J 1C4, Canada

Location

GSK Investigational Site

Beauport, Quebec, G1E 7G9, Canada

Location

GSK Investigational Site

Gatineau, Quebec, J8Y 6S8, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2K 4L5, Canada

Location

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Interventions

human papillomavirus vaccine, L1 type 16, 18

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; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

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 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Study Start: January 1, 2009
• Primary Completion: August 2, 2012
• Study Completion: August 2, 2012
• Last Updated: July 12, 2018
• Results First Posted: September 20, 2013

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

CA (9); US (39)