A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years

NCT00485732 | Completed Phase 3 Results

• 1 other identifier: 107291
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 6

Brief Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Papillomavirus

Keywords

Cervical neoplasia; AS04; Randomized; Cervical cancer; HPV-16/18 L1 VLP AS04; Phase IIIb; Korea; HPV; Double-blind; Controlled

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

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

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

• Number of Subjects Reporting Solicited Local Symptoms

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

• Number of Subjects Reporting Solicited General Symptoms

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

• 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 Medically Significant Conditions

  From Day 0 up to Month 7

Study Arms (2)

Cervarix Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

Biological: Placebo

Interventions

HPV-16/18 VLP/AS04 vaccine (Cervarix TM) 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 Group

Placebo BIOLOGICAL

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

Placebo Group

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• A female between, and including, 15 and 25 years of age at the time of the first vaccination.
• Written informed assent obtained from the subject and informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects must have a negative urine pregnancy test.
• Subjects of childbearing potential at the time of study entry must be abstinent, or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study/ control vaccine within 30 days preceding the first dose of study/ control vaccine, or planned use during the study period.
• Pregnant or breastfeeding.
• Planning to become pregnant or likely to become pregnant.
• Chronic administration (defined as more than 14 days) 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 the first dose of vaccine. However, the 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.
• Previous administration of components of the investigational vaccine
• Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
• Any medically diagnosed or suspected immunodeficient condition such as HIV infection based on medical history and physical examination.
• History of thrombocytopenia or hemostatic disorder in which case the study vaccine should under no circumstances be administered intramuscularly.
• History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study/control vaccines.
• Hypersensitivity to latex.
• Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
• History of chronic condition(s) requiring treatment.
• Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/control vaccine or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
• Acute disease at the time of enrolment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Seoul, 137-040, South Korea

Location

GSK Investigational Site

Seoul, 138-736, South Korea

Location

GSK Investigational Site

Seoul, 150-879, South Korea

Location

GSK Investigational Site

Seoul, 158-710, South Korea

Location

Related Publications (3)

• Kim SC, Song YS, Kim YT, Kim YT, Ryu KS, Gunapalaiah B, Bi D, Bock HL, Park JS. Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in 15-25 years old healthy Korean women. J Gynecol Oncol. 2011 Jun 30;22(2):67-75. doi: 10.3802/jgo.2011.22.2.67.

  PMID: 21860731 BACKGROUND

• Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

  PMID: 18845199 BACKGROUND

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

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

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 13, 2007
• Study Start: June 11, 2007
• Primary Completion: March 30, 2008
• Study Completion: March 30, 2008
• Last Updated: July 20, 2018
• Results First Posted: December 17, 2009

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

KR (6)