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Infections, Papillomavirus

48
Pipeline Programs
2
Companies
49
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
10
0
33
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
27100%
+ 80 programs with unclassified modality

Competitive Landscape

2 companies ranked by most advanced pipeline stage

ViiV Healthcare
ViiV HealthcareNC - Durham
58 programs
3
10
33
2
CervarixPhase 4
GSK Biologicals' HPV vaccine 580299Phase 4Vaccine
Boostrix ® PolioPhase 3
CervarixPhase 3
CervarixPhase 3
+53 more programs
GSK
GSKLONDON, United Kingdom
49 programs
Cancer Registry of NorwayN/A1 trial
CervarixN/A1 trial
Cervarix.N/A1 trial
Cervarix®N/A1 trial
Cervical samplesN/A1 trial
+44 more programs
Active Trials
NCT00924794Terminated410Est. Aug 2010
NCT01498627Completed2,945Est. Dec 2014
NCT01101542Completed3,091Est. Feb 2014
+46 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
GSKGSK Biologicals' HPV vaccine 580299
GSKCervarix
GSKCervarix™
GSKCervarix
GSKCervarixTM
GSKGSK Biologicals' HPV vaccine 580299
GSKGSK580299
GSKGSK580299
GSKGSK580299
GSKCervarixTM
GSKGynaecological follow-up
GSKLiquid-based cytology
GSKCervarix
GSKGSK580299, GSK Biological's HPV vaccine
GSKGSK Biological's HPV vaccine GSK580299

Showing 15 of 49 trials with date data

Clinical Trials (49)

Total enrollment: 88,238 patients across 49 trials

NCT01031069GSKGSK Biologicals' HPV vaccine 580299

Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females

Start: Oct 2010Est. completion: Apr 2017873 patients
Phase 4Completed

Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

Start: Oct 2007Est. completion: Dec 201434,412 patients
Phase 4Completed
NCT02082639GSKCervarix™

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus Vaccine (Cervarix™) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) in Healthy Female Adolescents Aged 9-14 Years

Start: Feb 2015Est. completion: Nov 20150
Phase 3Withdrawn

Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old

Start: Oct 2012Est. completion: Oct 2016148 patients
Phase 3Completed
NCT01418937GSKCervarixTM

Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study

Start: May 2012Est. completion: Jan 2015164 patients
Phase 3Completed
NCT01381575GSKGSK Biologicals' HPV vaccine 580299

Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls

Start: Jun 2011Est. completion: Nov 20141,447 patients
Phase 3Completed

Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

Start: Apr 2011Est. completion: Nov 2017137 patients
Phase 3Completed

Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)

Start: Feb 2011Est. completion: Feb 20121,212 patients
Phase 3Completed

The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

Start: Jan 2011Est. completion: Jan 2017199 patients
Phase 3Completed
NCT00996125GSKCervarixTM

Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects

Start: Oct 2009Est. completion: Dec 2010750 patients
Phase 3Completed
NCT00937950GSKGynaecological follow-up

Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects

Start: Aug 2009Est. completion: Jan 20142,022 patients
Phase 3Completed
NCT00929526GSKLiquid-based cytology

Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study

Start: Jun 2009Est. completion: Feb 2011752 patients
Phase 3Completed

Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.

Start: May 2009Est. completion: Sep 201092 patients
Phase 3Completed
NCT00849381GSKGSK580299, GSK Biological's HPV vaccine

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand

Start: Apr 2009Est. completion: Dec 20121,239 patients
Phase 3Completed
NCT00799825GSKGSK Biological's HPV vaccine GSK580299

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US

Start: Jan 2009Est. completion: Aug 2012346 patients
Phase 3Completed
NCT00652938GSKHPV Vaccine

Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects

Start: Apr 2008Est. completion: Jan 2010744 patients
Phase 3Completed
NCT00637195GSKSubjects received 3 doses of GSK Biologicals' HPV vaccine

Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)

Start: Mar 2008Est. completion: Jun 2009152 patients
Phase 3Completed
NCT00578227GSKCervarix™

Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

Start: Dec 2007Est. completion: Apr 2009814 patients
Phase 3Completed
NCT00552279GSKCervarix TM

Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age

Start: Nov 2007Est. completion: Jul 2009805 patients
Phase 3Completed
NCT00492544GSKCervarix™

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

Start: Jul 2007Est. completion: Mar 2008100 patients
Phase 3Completed
NCT00426361GSKBoostrix ® Polio

Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects

Start: Feb 2007Est. completion: Jul 2008751 patients
Phase 3Completed
NCT00369824GSKDifferent formulations of GSK Biologicals' HPV vaccine

Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects

Start: Sep 2006Est. completion: Feb 20081,330 patients
Phase 3Completed
NCT00306241GSKHPV-16/18 L1 VLP AS04

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

Start: Mar 2006Est. completion: Jun 2007300 patients
Phase 3Completed
NCT00290277GSKHPV-16/18 L1/AS04

Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years

Start: Nov 2005Est. completion: Aug 2006300 patients
Phase 3Completed
NCT00250276GSKCervarix™

Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

Start: Oct 2005Est. completion: Mar 2007798 patients
Phase 3Completed

Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18

Start: Oct 2004Est. completion: Dec 2005667 patients
Phase 3Completed
NCT00169494GSKHPV-16/18 L1/AS04

Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18

Start: Sep 2004Est. completion: Jul 2005770 patients
Phase 3Completed
NCT00196924GSKHPV-16/18 L1/AS04

Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.

Start: Jun 2004Est. completion: Mar 20062,067 patients
Phase 3Completed
NCT00122681GSKCervarix™

Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18

Start: May 2004Est. completion: Nov 200918,729 patients
Phase 3Completed
NCT00546078GSKCervarix™

Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America

Start: Jan 2008Est. completion: Dec 2009116 patients
Phase 2Completed
NCT00359619GSKCervarixTM

Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

Start: Sep 2006Est. completion: Jan 2007383 patients
Phase 2Completed
NCT00316693GSKHPV-16/18 vaccine

Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine

Start: Apr 2006Est. completion: Feb 20091,046 patients
Phase 2Completed
NCT00309166GSKCervarix vaccine

Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.

Start: Apr 2006Est. completion: Jun 2007270 patients
Phase 2Completed
NCT00231413GSKHPV 16/18 L1 AS04

Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

Start: Mar 2005Est. completion: Mar 2006383 patients
Phase 2Completed
NCT00120848GSKHPV 16/18 VLP AS04

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

Start: Nov 2003Est. completion: Jul 2007776 patients
Phase 2Completed
NCT00693615GSKMEDI-517 HPV-16/18 VLP AS04 vaccine

Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females

Start: Oct 2000Est. completion: Jan 200560 patients
Phase 2Completed
NCT00693966GSKMEDI-517 HPV-16/18 VLP AS04 vaccine

Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females

Start: Oct 1999Est. completion: Sep 2004210 patients
Phase 2Completed

A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females

Start: Dec 2007Est. completion: Jul 200830 patients
Phase 1Completed
NCT00478621GSKGSK Biologicals' HPV vaccine

Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)

Start: May 2007Est. completion: Oct 2008540 patients
Phase 1Completed
NCT01953822GSKData collection

Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom

Start: Oct 2013Est. completion: Aug 20141,053 patients
N/ACompleted
NCT01905462GSKData Collection

Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix Residing in UK

Start: Nov 2012Est. completion: Aug 20131,046 patients
N/ACompleted
NCT01290393GSKData collection

Post-marketing Study to Assess the Safety of CERVARIX When Used in the United States and in Canada

Start: Sep 2011Est. completion: Dec 20122 patients
N/ATerminated
NCT01153906GSKData collection

Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination

Start: Oct 2010Est. completion: Sep 20131,516 patients
N/ACompleted
NCT01187927GSKCervarix®

Drug Use Investigation for Cervarix®

Start: Sep 2010Est. completion: Jan 20141,230 patients
N/ACompleted

Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females

Start: Jul 2010Est. completion: Feb 20143,091 patients
N/ACompleted
NCT00924794GSKCancer Registry of Norway

Study of Natural History of Human Papillomavirus (HPV) Infections in Adult Women With Recurrent Conizations in Norway

Start: Jun 2010Est. completion: Aug 2010410 patients
N/ATerminated
NCT01213459GSKCervical samples

Study on the Prevalence of Human Papillomavirus Types in Women >= 15 Years of Age in the Kingdom of Saudi Arabia

Start: Apr 2010Est. completion: Dec 2011420 patients
N/ACompleted

Cervarix Long-term Safety Surveillance

Start: Aug 2008Est. completion: Dec 20142,945 patients
N/ACompleted
NCT01207999GSKCollection of cervical cancer tissue samples

Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer

Start: Oct 2007Est. completion: Mar 2010591 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

33 late-stage (Phase 3) programs, potential near-term approvals
2 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.