Phase 4 N=225 HPV Vaccination Study in Postpartum Women
HPV · Immunization · Human Papilloma Virus
Primary: Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer — 7177.6 mMU/mL
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N/A N=127 The Human Papilloma Virus Effect on Sexual Life
Human Papillomavirus Infection
Primary: Female Sexual Function Index (FSFI) Score — 0.8; 1.2; 0.9; 0.7 score on a scale
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 2 N=319 Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women
HIV Infections · Sexually Transmitted Diseases
Primary: Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series…
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 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
N/A N=156 Typing of Human Papilloma Virus (HPV) From Female Genital Warts
Genital Warts · Human Papilloma Virus
Primary: HPV DNA and HIV Status — 96; 19; 4; 5 participants
Phase 4 N=56 Postpartum HPV Vaccination
HPV-Related Malignancy
Primary: Patient Indication of Willingness to Accept the Vaccine Based on Survey — 56 Participants
Phase 3 N=314 Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)
Papillomavirus Infections
Primary: Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 — 100.0; 100.0; 100.0; 100.0 Percentage of Participants
Phase 4 N=372 Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study
Human Papillomavirus Infection
Primary: HPV Incidence Rates, Expressed as Incident Infections/1000 Infection-months at Risk. These Were Calculated Separately for Females and Males Across the Four Vaccine…
N/A N=33 HPV DNA Testing Through Mobile Mammography Unit
Cervical Cancer
Primary: Acceptability of Self-Collection Paired With Mobile Mammography — 33 Participants
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=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 3 N=3,006 Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
HPV Infections
Primary: Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus…
N/A N=57 Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV
HIV Infections · Human Papillomavirus Infection · Cervical Cancer
Primary: Prevalence of Abnormal Cervical Cytology — 12 Participants
Phase 2 N=99 Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women
HIV Infection
Primary: HPV-6 Antibody Level (Geometric Mean Titer of HPV-6) — 738.9 Milli-Merck units/milliliter (mMU/mL)
Phase 3 N=798 Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
Infections, Papillomavirus · Papillomavirus Vaccines
Primary: Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) — 118; 127; 126; 371…
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
N/A N=32 The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata
HIV Positive · Anal Condylomata · Anal Warts
Primary: The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups. — 1; 1 participants
N/A N=467 HPV Test-and-Treat-Strategy Versus Cytology-based Strategy for Prevention of CIN2+ in HIV-Infected Women
HIV-1 Infection
Primary: Cumulative Rate of Cervical Intraepithelial Neoplasia (CIN2+) (CIN2, CIN3 or Invasive Cancer) by Week 130 — 24.9; 26.5 Events per 100 persons
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
N/A N=1,210 HPV Typing Between Self- and Physician-sampled
Human Papillomavirus Infection · Self Sampling · Vaginal Discharge
Primary: Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. — 581; 611; 589; 559 Participants
Phase 1 N=150 Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
Cervical Cancer · Nonneoplastic Condition · Precancerous Condition
Primary: Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0 — 6.0 Grade 3/4 adverse events per 100 patient
Phase 4 N=200 Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers
Human Papillomavirus Infection
Primary: Antibody Response to HPV Vaccine for HPV 6,11,16,18. — 1086.49; 1054.13; 745.06; 776.84 Milli Merck Units — p=>0.20
Phase 3 N=575 Quadrivalent HPV Vaccine to Prevent Anal HPV in HIV-infected Men and Women
HIV Infections
Primary: Time to the First New Persistent Infection of HPV 6, 11, 16, or 18 — 1.90; 1.04; 2.92; 2.05 Years — p=0.350
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 2 N=149 Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
Anal Cancer · Nonneoplastic Condition · Penile Cancer
Primary: Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA — 0.0; 11.1 Events per 100 person years — p=0.112
N/A N=70 Vax Facts Human Papillomavirus (HPV): Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV
Human Papillomavirus · Prevention
Primary: Mother's Intention to Vaccinate Daughter Against HPV — 1.53; 1.29 units on a scale
Phase 1 N=40 An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
HPV Infections
Primary: Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5…