Clinical trials: HPV-16/18
Infections, Papillomavirus
Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb).
- Trial name
- NCT00196937
- Testing
- Cervarix
- Where
- 6 sites in Germany, Poland
- Volunteers
- 667 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neoplasms, Rectal
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30…
- Trial name
- NCT03671369
- Testing
- Safety data collection (following routine vaccination) by a continuous surveillance method.
- Where
- 29 sites in South Korea
- Volunteers
- 670 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb).
- Trial name
- NCT00316693
- Testing
- HPV-16/18 vaccine (Cervarix™), Aimmugen™
- Where
- 4 sites in Japan
- Volunteers
- 1,046 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women
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 .
- Trial name
- NCT00344032
- Testing
- HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)
- Where
- 4 sites in India
- Volunteers
- 354 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
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
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.
- Trial name
- NCT00485732
- Testing
- HPV-16/18 VLP/AS04 vaccine (Cervarix TM)
- Where
- 6 sites in South Korea
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or…
- Trial name
- NCT01462357
- Testing
- Cervarix, Gardasil
- Where
- 21 sites in France, Hong Kong and 2 more
- Volunteers
- 1,079 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
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…
- Trial name
- NCT00122681
- Testing
- Cervarix™, Havrix™-based investigational formulation
- Where
- 138 sites in United States, Australia and 12 more
- Volunteers
- 18,729 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cervical Cancer, Precancerous Condition
Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing, or coming back. Vaccines may help the body build an effective immune response against human papillomavirus and may be effective in…
- Trial name
- NCT00128661
- Testing
- human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine, hepatitis A inactivated virus vaccine
- Where
- Costa Rica
- Volunteers
- 7,466 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus, Papillomavirus Vaccines
Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age
HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18)…
- Trial name
- NCT00423046
- Testing
- GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM), Gardasil ® (Merck & Co. Inc)
- Where
- 40 sites in United States
- Volunteers
- 1,106 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs…
- Trial name
- NCT01101542
- Testing
- Cervarix., Data collection
- Where
- 2 sites in South Korea
- Volunteers
- 3,091 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls
This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old…
- Trial name
- NCT01381575
- Testing
- GSK Biologicals' HPV vaccine 580299
- Where
- 33 sites in Canada, Germany and 3 more
- Volunteers
- 1,447 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus, Papillomavirus Vaccines
Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
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 .
- Trial name
- NCT00250276
- Testing
- Cervarix™
- Where
- 8 sites in Denmark, Lithuania and 1 more
- Volunteers
- 798 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus, Papillomavirus Vaccines
Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older
This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control.
- Trial name
- NCT00294047
- Testing
- Cervarix
- Where
- 75 sites in United States, Australia and 10 more
- Volunteers
- 5,752 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cervical Intraepithelial Neoplasia, Papillomavirus Infection
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
This protocol posting deals with objectives \& outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all…
- Trial name
- NCT00316706
- Testing
- GSK Biologicals' HPV-16/18 Vaccine (Cervarix™), Havrix™
- Where
- 28 sites in Colombia, Germany and 3 more
- Volunteers
- 1,245 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cervical Cancer
The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer
A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer
- Trial name
- NCT03444376
- Testing
- GX-188E, KEYTRUDA®
- Where
- 9 sites in South Korea
- Volunteers
- 65 people
- Sponsor
- Genexine, Inc.
Infections, Papillomavirus
Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years
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.
- Trial name
- NCT00345878
- Testing
- HPV-16/18 L1 VLP AS04 (Cervarix TM)
- Where
- 2 sites in Malaysia
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old
The current study evaluates the immunogenicity and safety in 4-6 years old female subjects (experimental group) receiving Cervarix according to a 2-dose schedule (Month 0, 6), as compared to 4-6 years old female subjects (control…
- Trial name
- NCT01627561
- Testing
- Cervarix, Priorix, Infanrix
- Where
- 4 sites in Colombia, Mexico and 1 more
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Human Papillomavirus Infections
Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix
The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.
- Trial name
- NCT03610581
- Testing
- Ad26.HPV16, Ad26.HPV18, MVA.HPV16/18
- Where
- 12 sites in United States, Belgium
- Volunteers
- 9 people
- Sponsor
- Janssen Vaccines & Prevention B.V.
Cervical Intraepithelial Neoplasia
A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects
The purpose of this prospective, multi-centre, PMS cohort study was to monitor the safety of Cervarix, which is the first HPV vaccine licensed for use in China, to help prevent cervical cancer caused by HPV types 16 and 18.
- Trial name
- NCT03438006
- Testing
- Safety data collection (following routine vaccination)
- Where
- 7 sites in China
- Volunteers
- 3,016 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cervical Cancer, Genital Warts
Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)
The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.
- Trial name
- FUTURE II (NCT00092534)
- Testing
- Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
- Volunteers
- 12,167 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC