Trials: Gardasil Vaccine

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

National Cancer Institute (NCI) Results Jul 2025 2.1% serious AE View details

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

National Heart, Lung, and Blood Institute (NHLBI) Results Jul 2019 0.0% serious AE View details

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

University of Chicago Results Feb 2018 7.4% serious AE View details

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

Merck Sharp & Dohme LLC Results Dec 2015 View details

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

GlaxoSmithKline Results Aug 2010 7.3% serious AE View details

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

Merck Sharp & Dohme LLC Results May 2010 0.4% serious AE View details

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

GlaxoSmithKline Results Aug 2010 0.8% serious AE View details

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

GlaxoSmithKline Results Dec 2019 2.6% serious AE View details

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)…

GlaxoSmithKline Results Oct 2009 View details

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

GlaxoSmithKline Results Aug 2010 1.3% serious AE View details

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

GlaxoSmithKline Results Sep 2018 1.5% serious AE View details

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

GlaxoSmithKline Results Feb 2015 6.0% serious AE View details

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

GlaxoSmithKline Results Jan 2010 1.2% serious AE View details

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

GlaxoSmithKline Results Jul 2019 4.2% serious AE View details

Phase 1 N=37 Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients

Systemic Lupus Erythematosus

Primary: Frequency of Participants With Adverse Events — 21; 33 Participants

Wayne State University Results Nov 2018 2.9% serious AE View details

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

Merck Sharp & Dohme LLC Results Apr 2009 0.0% serious AE View details

Phase 4 N=15 Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease

Inflammatory Bowel Disease · Uterine Cervical Dysplasia

Primary: Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) — 120.5; 175.0; 861.0; 68.9 mMU/mL

Mayo Clinic Results Oct 2012 0.0% serious AE View details

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

Merck Sharp & Dohme LLC Results Sep 2010 1.1% serious AE View details

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…

Merck Sharp & Dohme LLC Results Jul 2010 0.2% serious AE View details

Phase 3 N=14,840 Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)

Cervical Cancer · Vulvar Cancer · Vaginal Cancer

Primary: Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis) — 0.5; 15.8 Cases per 10,000 person-years follow-up — p=<0.0001

Merck Sharp & Dohme LLC Results Dec 2014 2.5% serious AE View details

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

Merck Sharp & Dohme LLC Results Feb 2010 0.5% serious AE View details

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…

GlaxoSmithKline Results Aug 2010 3.8% serious AE View details

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

Merck Sharp & Dohme LLC Results Mar 2010 0.4% serious AE View details

Phase 3 N=12,167 Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)

Cervical Cancer · Genital Warts

Primary: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study — 0.0; 0.4…

Merck Sharp & Dohme LLC Results Nov 2009 0.6% serious AE View details

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…

Merck Sharp & Dohme LLC Results May 2020 2.2% serious AE View details

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…

GlaxoSmithKline Results Jan 2010 8.9% serious AE View details

Phase 4 N=25 Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?

Cervical Cancer · Hpv · Warts

Primary: Number of Subjects Showing Seroconversion to All HPV Four Serotypes — 9 Participants

Medstar Health Research Institute Results Dec 2020 12.0% serious AE View details

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…

GlaxoSmithKline Results Jan 2016 1.1% serious AE View details

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

GlaxoSmithKline Results Mar 2010 5.5% serious AE View details

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

Merck Sharp & Dohme LLC Results Feb 2020 0.5% serious AE View details

Clinical Trial Search

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

Phase 1 N=64 Gardasil Vaccination in Post Stem Cell Transplant Patients

N/A N=27 Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

N/A N=54,516 GARDASIL™ Vaccine Impact in Population Study (V501-033)

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

Phase 3 N=1,781 A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

Phase 3 N=741 Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects

Phase 2 N=383 Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

Phase 3 N=1,283 Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects

Phase 3 N=751 Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects

Phase 2 N=270 Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.

Phase 2 N=383 Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

Phase 3 N=813 Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

Phase 4 N=546 Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females

Phase 1 N=37 Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients

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)

Phase 4 N=15 Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease

Phase 3 N=176 Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)

Phase 3 N=600 An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)

Phase 3 N=14,840 Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)

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)

Phase 3 N=666 Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18

Phase 3 N=3,055 Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)

Phase 3 N=12,167 Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)

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)

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

Phase 4 N=25 Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?

Phase 4 N=32,175 Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

Phase 3 N=770 Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women

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)