A Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years

NCT00306241 | Completed Phase 3

• 1 other identifier: 106001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immune response induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Papillomavirus

Keywords

Cervical neoplasia; Cervical cancer; Double-blind; HPV-16/18 L1 VLP AS04; HPV; AS04

Outcome Measures

Primary Outcomes (1)

• Seroconversion rates to HPV-16 and HPV-18 as assessed by enzyme-linked immunosorbent assay (ELISA)

  At Month 7

Secondary Outcomes (5)

• Occurrence of SAEs

  Throughout the study period (up to Month 7)

• Occurrence, intensity and relationship to vaccination of solicited general symptoms, and occurrence and intensity of solicited local symptoms

  During the 7 days after each and any vaccination

• Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms

  Within 30 days after any vaccination

• Occurrence of new onset chronic diseases and other medically significant conditions regardless of causal relationship to vaccination and intensity.

  Throughout the study period (up to Month 7)

• Anti-HPV-16/18 antibody titres (by ELISA)

  At Month 0 and Month 7

Interventions

HPV-16/18 L1 VLP AS04 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 female of Chinese origin, residing in Hong Kong aged between, and including, 18 and 35 years at the time of the first vaccination.
• Written informed consent obtained from 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 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. 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 based on medical history and physical examination.
• 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 (1)

GSK Investigational Site

Hong Kong, Hong Kong

Location

Related Publications (3)

• Ngan HY, Cheung AN, Tam KF, Chan KK, Tang HW, Bi D, Descamps D, Bock HL. Human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in healthy Chinese women from Hong Kong. Hong Kong Med J. 2010 Jun;16(3):171-9.

  PMID: 20519752 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

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2006
• First Posted: March 23, 2006
• Study Start: March 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 4, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)