Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age

NCT00492544 | Completed Phase 3 Results

• 1 other identifier: 110168
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials, the vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV vaccination should ideally be performed before onset of sexual activity. Previous studies showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy Japanese pre-adolescent and adolescent female subjects aged 10-15 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Papillomavirus

Keywords

Human Papillomavirus (HPV) vaccine; safety; cervical cancer; immunogenicity; vaccine; viral infections; pre-adolescent and adolescent females

Outcome Measures

Primary Outcomes (4)

• Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies

  Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

  One month post Dose 3 (Month 7)

• Anti-HPV-16 and Anti-HPV-18 Antibody Titers

  Titers are given as geometric mean titers (GMTs) calculated on all subjects.

  Before vaccination (PRE) and one month post Dose 3 (Month 7)

• Number of Subjects Reporting Solicited Local Symptoms

  Solicited local symptoms assessed include pain, redness and swelling.

  During the 7-day (Days 0-6) period following each vaccination

• Number of Subjects Reporting Solicited General Symptoms

  Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.

  During the 7-day (Days 0-6) period following each vaccination

Secondary Outcomes (5)

• Number of Subjects Reporting Unsolicited Adverse Events (AE)

  During the 30-day (Days 0-29) period following each vaccination

• Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions

  From Day 0 up to Month 7

• Outcome of All Pregnancies

  Up to Month 7

• Number of Subjects Reporting Serious Adverse Events (SAEs)

  From Day 0 up to Month 7

• Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters

  At Day 0 and Month 7

Study Arms (1)

Cervarix

EXPERIMENTAL

Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.

Biological: Cervarix™ (HPV-16/18 L1 VLP AS04)

Interventions

Cervarix™ (HPV-16/18 L1 VLP AS04) BIOLOGICAL

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Also known as: GSK Biologicals' HPV-16/18 VLP/AS04 vaccine

Cervarix

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator/co-investigator believes that they and/or their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol should be enrolled in the study.
• A Japanese female between, and including, 10 and 15 years of age at the time of the first vaccination.
• Written informed consent obtained from the parent(s) or legally acceptable representative(s) of the subject. In addition, a written informed assent must be obtained from the subject prior to enrolment.
• Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
• All subjects must have a negative urine pregnancy test.
• Subjects must be of non-childbearing potential, or, if of childbearing potential, they must be abstinent or have used adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Non-abstinent pre-menarche subjects, as well as subjects who reach menarche during study, must follow the same precautions.

You may not qualify if:

• 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.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during study.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Administration of 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.
• Concurrently participating in another clinical study, at any time during the study period (up to Month 7), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 7).
• Previous administration of components of the investigational vaccine .
• Cancer or autoimmune disease under treatment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Hypersensitivity to latex.
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or breastfeeding subject.
• Subject planning to become pregnant or planning to discontinue contraceptive precautions.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Saitama, 360-0812, Japan

Location

GSK Investigational Site

Saitama, 360-0846, Japan

Location

GSK Investigational Site

Tokyo, 136-0073, Japan

Location

GSK Investigational Site

Tokyo, 154-0024, Japan

Location

GSK Investigational Site

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; Uterine Cervical Neoplasms; Virus Diseases

Interventions

human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; 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: June 26, 2007
• First Posted: June 27, 2007
• Study Start: July 2, 2007
• Primary Completion: March 28, 2008
• Study Completion: March 28, 2008
• Last Updated: September 4, 2018
• Results First Posted: December 21, 2009

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (4)