Clinical trials: HPV-16
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
Hpv, HPV 16 Infection
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing…
- Conditions
- Hpv, HPV 16 Infection, HPV Infection, High Risk HPV
- Trial name
- NCT06120205
- Testing
- Teal Wand Self-Collection Device Group
- Where
- 15 sites in United States
- Volunteers
- 870 people, healthy volunteers welcome
- Sponsor
- Teal Health, Inc.
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
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
Healthy
Study to Evaluate the Safety and Immunogenicity of MEDI-517P in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive
The primary objective of this study is to describe the safety of 40 mg MEDI-517, with a control of aluminum hydroxide, when given to healthy adult women who have evidence of HPV-16 and/or HPV-18 DNA detected in cervical brushings.
- Trial name
- NCT00263744
- Testing
- MEDI 517, Aluminum hydroxide
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
HSIL of Cervix
Clinical Study of HPV Therapeutic DNA Vaccine (NWRD08) in Patients With Cervical HPV16 and/or HPV18 Positive
This is an open-label exploratory clinical study. The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.
- Trial name
- NCT05905354
- Testing
- NWRD08
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Newish Technology (Beijing) Co., Ltd.
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
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
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, 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
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
HPV 16 Infection
Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)
Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.
- Trial name
- NCT00365378
- Testing
- Comparator: HPV 16 L1 Vaccine
- Volunteers
- 2,409 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
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
Human Papillomavirus Infection
APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results
In both the ASC-US Study and Adjunct Study populations, the objectives are to: evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and…
- Trial name
- AHPV-GT (NCT01384370)
- Where
- 3 sites in United States
- Volunteers
- 1,260 people, healthy volunteers welcome
- Sponsor
- Gen-Probe, Incorporated
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
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
Human Papillomavirus Infection
Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System
The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System in cervical cancer screening. This objective will be accomplished in the ASC-US Study by evaluating the performance characteristics of…
- Trial name
- NCT01694875
- Testing
- APTIMA HPV Assay
- Where
- 3 sites in United States
- Volunteers
- 2,200 people, healthy volunteers welcome
- Sponsor
- Gen-Probe, Incorporated
Infections, Papillomavirus
Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study
This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus…
- Trial name
- NCT00929526
- Testing
- Liquid-based cytology (LBC) sampling, Blood sampling
- Where
- 13 sites in Japan
- Volunteers
- 752 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline