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Albuquerque, New Mexico 87131

  • Infections, Papillomavirus

Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

580299/007


NCT ID:

NCT00120848


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Study of the Efficacy of Candidate HPV 16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Adolescent & Young Adult Women in North America and Brazil Vaccinated in Primary Study 580299/001


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

20 Years


Maximum Age:

30 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

776


Enrollment Type:

Actual


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director
GlaxoSmithKline

Study Dates

Start Date:November 2003
Completion Date:July 2007
Completion Type:Actual
Primary Completion Date:July 2007
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 2, 2016
First Received Date:July 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Abnormal cytology associated with oncogenic HPV type cervical infection.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Abnormal cytology associated with an HPV-16 and/or HPV-18 cervical infection.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Histopathologically-confirmed CIN 1+ or CIN 2+ associated with oncogenic HPV types detected within the lesional component of the cervical tissue specimen.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Histopathologically-confirmed CIN 1+ or CIN 2+ associated with HPV 16 and/or HPV 18 detected within the lesional component of the cervical tissue specimen.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incident cervical infection with oncogenic HPV types.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Persistent cervical infection (6-month definition) with oncogenic HPV types.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Persistent cervical infection (6-month definition) with HPV 16 and/or HPV 18.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Incident cervical infection with HPV-16 and/or HPV-18
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:HPV 16/18 VLP AS04

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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
Reference Type:Reference
Citation:Schwarz TF et al. (2011) Overview of clinical evidence: Cervarix. Future Medicine - Human Papillomavirus Vaccines. 38-50.
Reference Type:Reference
Citation: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.
PMID:19962185
Reference Type:Reference
Citation: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:Reference
Citation: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.
PMID:16631880
Reference Type:Reference
Citation: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.
PMID:19221517
Reference Type:Reference
Citation: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.
PMID:19217149

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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