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
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N/A N=2,868 Increasing Vaccine Uptake Among Adolescents in the Rural South
Vaccine Hesitancy
Primary: Difference in the Percentage of Adolescents Who Ever Received at Least One Dose of HPV Vaccination in the Intervention Group After the Intervention Implementation…
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=3,074 A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
Cervical Cancers · Vulvar Cancer · Vaginal Cancer
Primary: Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])…
Phase 3 N=110 Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)
Papillomavirus Infections
Primary: Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7 — 96.97; 99.05; 99.05; 99.05 percentage of participants
Phase 3 N=216 Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females
Vaccination
Primary: GARDASIL Vaccination Uptake and Compliance With Second and Third Doses — 12; 12; 8; 3 participants — p=>.05
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 2 N=383 Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
Infections, Papillomavirus
Primary: Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7 — 62; 27; 31; 23 Participants
Phase 2 N=1,499 Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Cancer Survivor · Prevention of Human Papillomavirus Infection
Primary: Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey]) — 179 Participants
Phase 3 N=750 Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects
Infections, Papillomavirus
Primary: Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens — 18347.1; 5.0; 7960.2; 4.1 EL.U/mL
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
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 4 N=72 Alternate Dosing Schedules Study for HPV Vaccine
Cervical Cancer · Genital Warts
Primary: Pain Following HPV Vaccine — 17; 32 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=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=770 Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Papillomavirus Type 16/18 Infection · Cervical Intraepithelial Neoplasia
Primary: Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies — 1440.4; 1903.7; 3861.7; 1397.5 EL.U/mL
Phase 3 N=100 Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 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 — 92; 94 Participants
Phase 3 N=1,042 Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)
Neoplasms, Glandular and Epithelial · Diphtheria · Tetanus
Primary: Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months) — 416; 417 Participants — p=<0.001
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 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=1,245 Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
Cervical Intraepithelial Neoplasia · Papillomavirus Infection
Primary: Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies — 3901.6; 3226.3; 2688.6; 2395.8 EL.U/mL
Phase 4 N=801 A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
Meningococcal Meningitis
Primary: Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM…
N/A N=3,076 SDH of HPV Vaccine Completion
Human Papilloma Virus
Primary: Overall HPV Vaccine Completion Rates — 1961; 1083 Participants
Phase 3 N=1,518 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)
Human Papillomavirus Infection
Primary: Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen — 1657.9; 1557.4; 2678.8; 1496.1 mMU/mL — p=<0.001
Phase 3 N=18,644 Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
Infections, Papillomavirus
Primary: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA…
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 1 N=150 Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
Human Papilloma Virus · Cervical Cancer · Vulvar Cancer
Primary: Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A — 1273.3; 2203.0; 4784.7; 1991.6 mMU/mL
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=2,520 Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
Genital Warts · Anal Cancer · Anal Intraepithelial Neoplasia
Primary: Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine — 782.0; 703.9; 568.9; 616.7 milli Merck Units/mL — p=<0.001
Phase 4 N=767 GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose
Immunization · Efficacy · Human Papilloma Virus
Primary: Short-term Human Papillomavirus (HPV) Type-specific Antibody Response for Type HPV-6 — 99.25; 100.00; 100.00; 100.00 % of participants with seroconversion