Clinical trials: HPV 16 Infection
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
Cervical Cancers, Vulvar Cancer
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent participants between 9 and 15 years old and…
- Conditions
- Cervical Cancers, Vulvar Cancer, Vaginal Cancer, Genital Lesions
- Trial name
- NCT00943722
- Testing
- V503
- Volunteers
- 3,074 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Neoplasms, Glandular and Epithelial, Diphtheria
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and…
- Conditions
- Neoplasms, Glandular and Epithelial, Diphtheria, Tetanus, Whooping Cough
- Trial name
- NCT00337428
- Testing
- Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF), Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF), Comparator: REPEVAX™ (Concomitant)
- Volunteers
- 843 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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, 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
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
Genital Warts, Anal Cancer
Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women.
- Conditions
- Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia
- Trial name
- NCT01651949
- Testing
- 9vHPV Vaccine
- Volunteers
- 2,520 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
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.
Human Papillomavirus Infection
A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age.
- Trial name
- NCT01984697
- Testing
- V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
- Volunteers
- 1,518 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Adult Female Participants, Prevention
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.
- Conditions
- Healthy Adult Female Participants, Prevention, Papillomavirus Infection, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
- Trial name
- NCT00090220
- Testing
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Volunteers
- 3,819 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Warts, Genital, Neoplasms, Anal
Efficacy, Immunogenicity, and Safety Study of V503 (9-valent Human Papillomavirus [9vHPV] Vaccine) in Japanese Males (V503-064)
The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the…
- Trial name
- NCT04635423
- Testing
- V503
- Where
- 22 sites in Japan
- Volunteers
- 1,059 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Meningococcal Meningitis
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline, Boostrix®) and HPV vaccine (Merck \& Co., Inc., Gardasil®) when administered concomitantly with MenACWY are comparable to responses elicited by…
- Trial name
- NCT01424644
- Testing
- MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine
- Where
- 20 sites in United States, Italy
- Volunteers
- 801 people, healthy volunteers welcome
- Sponsor
- Novartis
Cervical Cancer, Genital Warts
Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.
- Trial name
- NCT00092495
- Testing
- V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
- Volunteers
- 3,055 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Anogenital Human Papilloma Virus Infection, Condyloma Acuminata
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males.
- Trial name
- NCT01862874
- Testing
- V501
- Volunteers
- 1,124 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Papillomavirus
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
This study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology…
- Trial name
- NCT01190176
- Testing
- Gynaecological follow-up, Cervarix
- Where
- 20 sites in United States, Canada and 5 more
- Volunteers
- 34 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