Phase 1 N=64 Gardasil Vaccination in Post Stem Cell Transplant Patients
Gardasil Vaccine · Stem Cell Transplant · Immunogenicity
Primary: Percentage of Subjects Who Developed Antibody Response to the Vaccine. — 18; 20; 20 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=1,240 Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial
Human Papillomavirus-Related Cervical Carcinoma
Primary: Number Seropositive for HPV16 at 36 Months — 538; 366 Participants
Phase 3 N=741 Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects
Infections, Papillomavirus
Primary: Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection — 190; 181 Participants
N/A N=54,516 GARDASIL™ Vaccine Impact in Population Study (V501-033)
Human Papillomavirus Infections
Primary: Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark — 164.2; 191.4; 217.7; 240.3 Cases per 100,000 women
Phase 3 N=751 Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects
Infections, Papillomavirus
Primary: Number of Subjects Seroprotected Against Diphtheria and Tetanus — 238; 233; 240; 233 Participants
Phase 3 N=1,283 Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
Infections, Papillomavirus
Primary: Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)…
Phase 3 N=1,106 Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age
Infections, Papillomavirus · Papillomavirus Vaccines
Primary: Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies — 36791.8; 10053.1; 16486.9; 2257.9 titer
Phase 3 N=813 Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects
Infections, Papillomavirus
Primary: Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies — 240; 242 Participants
Phase 3 N=600 An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)
Papillomavirus Infections
Primary: Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines) — 7; 7…
N/A N=3,605 GARDASIL Reexamination Study (V501-059)
Human Papillomavirus (HPV) Infection
Primary: Percentage of Participants With Any Adverse Experience — 11.29 Percent of participants
Phase 3 N=843 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)
Neoplasms, Glandular and Epithelial · Diphtheria · Tetanus
Primary: Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3) — 1151.3; 1244.9 milliMerck units/mL — p=<0.001
Phase 3 N=3,055 Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
Cervical Cancer · Genital Warts
Primary: Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 — 423; 428; 320; 0 Subjects — p=<0.001
Phase 3 N=1,781 A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
Human · Papillomavirus Infections
Primary: Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 — 6; 0 participants
Phase 3 N=1,212 Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
Cervical Cancer · Vulvar Cancer · Vaginal Cancer
Primary: Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type — 787.8; 638.4; 598.7; 453.5 mMU/mL — p=< 0.001
Phase 3 N=176 Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
Papillomavirus Infections
Primary: Number of Participants Who Seroconvert to HPV 6. — 109; 0 Participants
N/A N=27 Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
Systemic Lupus Erythematosus
Primary: Anti-HPV 6 Seroconversion — 93.8 percentage of participants
Phase 3 N=201 Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)
Papillomavirus Infections · Uterine Cervical Neoplasms · Vulvar Neoplasms
Primary: Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7 — 100; 100; 100; 100.0 Percentage of Participants
Phase 2 N=383 Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
Infections, Papillomavirus · Papillomavirus Vaccines
Primary: Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies. — 27; 10; 9; 8 subjects
Phase 3 N=676 Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age.
Human Papillomavirus (HPV) Infection
Primary: Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies — 130; 4; 190; 5 Participants
Phase 4 N=32,175 Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
Infections, Papillomavirus
Primary: Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus…
Phase 3 N=600 Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)
Human Papillomavirus
Primary: Geometric Mean Titers (GMTs) to HPV Types 16 and 18 — 6739.5; 6887.4; 1956.6; 1795.6 milli Merck Units/mL — p=<0.001
Phase 2 N=270 Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.
Infections, Papillomavirus
Primary: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 — 163; 1; 150; 2 Participants
Phase 3 N=250 GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)
Papillomavirus Infections
Primary: Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6 — 147; 1 Participants
N/A N=189,629 Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
Human Papillomavirus Infection
Primary: Incidence Rate of Syncope — 24.21; 13.84 Rate per 1000 person years
Phase 3 N=924 A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)
Cervical Cancers · Vulvar Cancers · Vaginal Cancers
Primary: Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study — 91.1; 43.9 Percentage of Participants
Phase 3 N=666 Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
Infections, Papillomavirus
Primary: Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of…
Phase 4 N=546 Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
Infections, Papillomavirus · Papillomavirus Vaccines
Primary: Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms — 115; 58; 4; 0 Participants
Phase 3 N=804 Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age
Infections, Papillomavirus
Primary: Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies — 337; 342; 345; 346…
Phase 3 N=766 A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)
Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ
Primary: Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA) — 975.2; 686.6; 807.4; 580.2…
N/A N=903 Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil
Dose Schedule Study
Primary: Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. — 0.93; 0.99; 0.63; 1.0 GMT ratio