Clinical trials: HPV-16/ 18
Infections, Papillomavirus
Efficacy Study of HPV-16/18 Vaccine (GSK 580299) to Prevent HPV-16 and/or -18 Cervical Infection in Young Healthy Women
The purpose of this phase IIB MedImmune-sponsored study was to evaluate the efficacy of the HPV-16/18 VLP vaccine in the prevention of infection with HPV-16 and/or HPV-18 in adolescent and young adult women.
- Trial name
- NCT00689741
- Testing
- Cervarix
- Volunteers
- 1,113 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Human Papillomavirus Infection
Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri Lanka
This PMS study aims to collect safety and reactogenicity data of Cervarix in the local population as per the licensing requirement of the Sri Lankan regulatory authority.
- Trial name
- NCT01551537
- Testing
- Cervarix data collection, Data Collection
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Infections, Papillomavirus
Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio 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
- NCT00169494
- Testing
- HPV-16/18 L1/AS04
- Where
- 17 sites in Denmark, Estonia and 4 more
- Volunteers
- 770 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Human Papillomavirus
Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females
Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group.
- Trial name
- NCT02740790
- Testing
- HPV vaccine
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
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
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
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
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
Papillomavirus Type 16/18 Infection, Cervical Intraepithelial Neoplasia
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine.
- Trial name
- NCT00337818
- Testing
- Cervarix™
- Where
- Estonia
- Volunteers
- 770 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Antibody Persistence for GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) Administered in Healthy Adults and Adolescents, 6.5 Years After First Vaccination in the Primary Study
The purpose of this study is to establish the long-term persistence of the immune response and safety of the HPV vaccine in healthy females who were aged 9 to 25 years in the primary study (NCT00541970).
- Trial name
- NCT02100618
- Testing
- Blood sampling
- Volunteers
- 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
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, Genital Warts
Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)
The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.
- Trial name
- NCT00092482
- Testing
- V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years
- Volunteers
- 3,882 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
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 Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio 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
- NCT00196924
- Testing
- HPV-16/18 L1/AS04
- Where
- 61 sites in Australia, Colombia and 10 more
- Volunteers
- 2,067 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Human Papillomavirus, Cervical Intraepithelial Neoplasia
Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females
To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle vaccine (type 16 and 18 L1 proteins, yeast)…
- Conditions
- Human Papillomavirus, Cervical Intraepithelial Neoplasia, Persistent Infection
- Trial name
- NCT02740777
- Testing
- HPV-16/18 vaccine
- Where
- 2 sites in China
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Shanghai Zerun Biotechnology Co.,Ltd