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Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults

NCT ID: NCT00120848

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-07-31

Brief Summary

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Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

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Conditions

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Infections, Papillomavirus

Keywords

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HPV vaccine efficacy Prophylaxis HPV 16/18 infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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HPV 16/18 VLP AS04

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participated in study 580299/001 and received all three doses of vaccine/placebo.
* Written informed consent obtained from the subject prior to enrollment

Exclusion Criteria

* Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

Augusta, Georgia, United States

Site Status

GSK Investigational Site

Bardstown, Kentucky, United States

Site Status

GSK Investigational Site

Louisville, Kentucky, United States

Site Status

GSK Investigational Site

Lebanon, New Hampshire, United States

Site Status

GSK Investigational Site

Morristown, New Jersey, United States

Site Status

GSK Investigational Site

Albuquerque, New Mexico, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Salt Lake City, Utah, United States

Site Status

GSK Investigational Site

West Jordan, Utah, United States

Site Status

GSK Investigational Site

Seattle, Washington, United States

Site Status

GSK Investigational Site

Marshfield, Wisconsin, United States

Site Status

GSK Investigational Site

Curitiba, Paraná, Brazil

Site Status

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

GSK Investigational Site

São Paulo, São Paulo, Brazil

Site Status

GSK Investigational Site

Campinas, , Brazil

Site Status

GSK Investigational Site

Fortaleza, , Brazil

Site Status

GSK Investigational Site

Edmonton, Alberta, Canada

Site Status

GSK Investigational Site

Langley, British Columbia, Canada

Site Status

GSK Investigational Site

Winnipeg, Manitoba, Canada

Site Status

GSK Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

Countries

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United States Brazil Canada

References

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David MP, Van Herck K, Hardt K, Tibaldi F, Dubin G, Descamps D, Van Damme P. Long-term persistence of anti-HPV-16 and -18 antibodies induced by vaccination with the AS04-adjuvanted cervical cancer vaccine: modeling of sustained antibody responses. Gynecol Oncol. 2009 Dec;115(3 Suppl):S1-6. doi: 10.1016/j.ygyno.2009.01.011. Epub 2009 Feb 12.

Reference Type BACKGROUND
PMID: 19217149 (View on PubMed)

Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.

Reference Type BACKGROUND
PMID: 19221517 (View on PubMed)

Harper DM, Franco EL, Wheeler CM, Moscicki AB, Romanowski B, Roteli-Martins CM, Jenkins D, Schuind A, Costa Clemens SA, Dubin G; HPV Vaccine Study group. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet. 2006 Apr 15;367(9518):1247-55. doi: 10.1016/S0140-6736(06)68439-0.

Reference Type BACKGROUND
PMID: 16631880 (View on PubMed)

Katherine A et al. (2012) Adjuvanted human papillomavirus types 16/18 vaccine (Cervarix®): a guide to its use. Adis Drug Eval Drug Prof. 28(3):1-6.

Reference Type BACKGROUND

GlaxoSmithKline Vaccine HPV-007 Study Group; Romanowski B, de Borba PC, Naud PS, Roteli-Martins CM, De Carvalho NS, Teixeira JC, Aoki F, Ramjattan B, Shier RM, Somani R, Barbier S, Blatter MM, Chambers C, Ferris D, Gall SA, Guerra FA, Harper DM, Hedrick JA, Henry DC, Korn AP, Kroll R, Moscicki AB, Rosenfeld WD, Sullivan BJ, Thoming CS, Tyring SK, Wheeler CM, Dubin G, Schuind A, Zahaf T, Greenacre M, Sgriobhadair A. Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet. 2009 Dec 12;374(9706):1975-85. doi: 10.1016/S0140-6736(09)61567-1.

Reference Type BACKGROUND
PMID: 19962185 (View on PubMed)

Schwarz TF et al. (2011) Overview of clinical evidence: Cervarix. Future Medicine - Human Papillomavirus Vaccines. 38-50.

Reference Type 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.

Reference Type BACKGROUND
PMID: 18845199 (View on PubMed)

El-Zein M, Ramanakumar AV, Naud P, Roteli-Martins CM, de Carvalho NS, Colares de Borba P, Teixeira JC, Moscicki AB, Harper DM, Tyring SK, Ramjattan B, Dubin G, Franco EL; HPV-007 Study Group. Determinants of Acquisition and Clearance of Human Papillomavirus Infection in Previously Unexposed Young Women. Sex Transm Dis. 2019 Oct;46(10):663-669. doi: 10.1097/OLQ.0000000000001053.

Reference Type DERIVED
PMID: 31464859 (View on PubMed)

Ramanakumar AV, Naud P, Roteli-Martins CM, de Carvalho NS, de Borba PC, Teixeira JC, Blatter M, Moscicki AB, Harper DM, Romanowski B, Tyring SK, Ramjattan B, Schuind A, Dubin G, Franco EL; HPV-007 Study Group. Incidence and duration of type-specific human papillomavirus infection in high-risk HPV-naive women: results from the control arm of a phase II HPV-16/18 vaccine trial. BMJ Open. 2016 Aug 26;6(8):e011371. doi: 10.1136/bmjopen-2016-011371.

Reference Type DERIVED
PMID: 27566633 (View on PubMed)

Naud PS, Roteli-Martins CM, De Carvalho NS, Teixeira JC, de Borba PC, Sanchez N, Zahaf T, Catteau G, Geeraerts B, Descamps D. Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination. Hum Vaccin Immunother. 2014;10(8):2147-62. doi: 10.4161/hv.29532.

Reference Type DERIVED
PMID: 25424918 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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580299/007

Identifier Type: -

Identifier Source: org_study_id