Clinical trials: HPV Vaccines
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
Infections, Papillomavirus
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV…
- Trial name
- NCT00947115
- Testing
- Blood sampling, Cervico-vaginal secretion (CVS) samples
- Where
- 6 sites in Germany, Poland
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Human Papillomavirus Associated Intraepithelial Neoplasia, Cervical Intraepithelial Neoplasia Grade 2/3
A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3
The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3).
- Conditions
- Human Papillomavirus Associated Intraepithelial Neoplasia, Cervical Intraepithelial Neoplasia Grade 2/3, Human Papillomavirus Type 16 Infection, Human Papillomavirus Type 18 Infection
- Trial name
- NCT06273553
- Testing
- RG002 injection
- Volunteers
- 39 people
- Sponsor
- RinuaGene Biotechnology Co., Ltd.
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, Papillomavirus Vaccines
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV 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
- NCT00359619
- Testing
- CervarixTM, HPV investigational vaccine GSK568893A, different formulations
- Where
- 10 sites in United States, Belgium
- Volunteers
- 383 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Adult Solid Tumor
Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-AAC-HPV as monotherapy and in combination with immune checkpoint inhibitors in…
- Trial name
- NCT04892043
- Testing
- SQZ-AAC-HPV, Ipilimumab, Nivolumab
- Where
- 6 sites in United States
- Volunteers
- 5 people
- Sponsor
- SQZ Biotechnologies
Papillomavirus Infections
A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).
This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV)…
- Trial name
- NCT01254643
- Testing
- V503
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC
VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous…
- Conditions
- Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Neoplasms, Head and Neck
- Trial name
- VERSATILE002 (NCT04260126)
- Testing
- Pembrolizumab (KEYTRUDA®) and PDS0101
- Where
- 23 sites in United States, Ireland and 2 more
- Volunteers
- 95 people
- Sponsor
- PDS Biotechnology Corp.
Infections, Papillomavirus
Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)
This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years.
- Trial name
- NCT01277042
- Testing
- GSK580299 (CervarixTM), Engerix-BTM
- Where
- China
- Volunteers
- 1,212 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Papillomavirus Infections, Genital Diseases, Female
Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)
This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation.
- Trial name
- NCT00365716
- Testing
- Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20, Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40, Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
- Volunteers
- 1,158 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
Infections, Papillomavirus
The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
This extension study is designed to assess the safety of GSK Biological's HPV vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the…
- Trial name
- NCT01249365
- Testing
- GSK580299 (Cervarix)
- Where
- 15 sites in Australia, Portugal and 2 more
- Volunteers
- 199 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus, Papillomavirus Vaccines
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected…
- Trial name
- NCT01031069
- Testing
- GSK Biologicals' HPV vaccine 580299, Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
- Where
- 15 sites in Brazil, Estonia and 2 more
- Volunteers
- 873 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Papillomavirus Infections
GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)
This study will collect safety information on the use of GARDASIL™ in the Philippines.
- Trial name
- NCT01355003
- Volunteers
- 1,080 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Papillomavirus Infections
Immunobridging Study of 9- Valent Human Papillomavirus (9vHPV) Vaccine (V503) in Chinese Females 9 to 45 Years of Age (V503-024)
This study investigates the immunogenicity and safety of the 9vHPV vaccine in healthy Chinese females 9 to 45 years of age. The study consists of Stage I (Day 1 to Month 7) and Stage II (post Month 7 to Month 60).
- Trial name
- NCT03903562
- Testing
- V503
- Where
- 2 sites in China
- Volunteers
- 1,990 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Papillomavirus
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.
The main aim of this vaccine is to prevent cervical cancer in women. However, it could also be relevant to vaccinate selected groups of males.
- Trial name
- NCT00309166
- Testing
- Cervarix vaccine, Engerix-B vaccine
- Where
- 5 sites in Finland
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cervical Intraepithelial Neoplasia
Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E)
The purpose of this study is to access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)
- Trial name
- NCT02596243
- Testing
- GX-188E
- Where
- 16 sites in Estonia, South Korea and 1 more
- Volunteers
- 134 people
- Sponsor
- Genexine, Inc.
HPV 16- and/or HPV 18-Infected Women With Normal Cytology, ASCUS, or LSIL
Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or LSIL
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or…
- Trial name
- NCT02689726
- Testing
- GTL001+, Aldara
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Genticel
Cervical Cancer, Vulvar Cancer
Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1
- Trial name
- NCT04425291
- Testing
- 4-valent HPV Vaccine, 9-valent HPV Vaccine, GARDASIL®
- Where
- China
- Volunteers
- 1,680 people, healthy volunteers welcome
- Sponsor
- Shanghai Bovax Biotechnology Co., Ltd.
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