Phase 3
Completed N=3,819
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
Healthy Adult Female Participants · Prevention · Papillomavirus Infection · Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Source: ClinicalTrials.gov NCT00090220 ↗
Enrolled (actual)
3,819
Serious AEs
0.7%
Results posted
Feb 2010
Primary outcomePrimary: Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer — 0.2; 1.7 Incidence per 100 person-years
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer |
0.2; 1.7 | — |
| PRIMARY Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study |
0; 0 | — |
| PRIMARY Number of Participants With Vaccine-Related SAEs After Vaccine Administration |
0; 1 | — |
| PRIMARY Number of Participants With an SAE Resulting in Death After Vaccine Administration |
8; 4 | — |
| PRIMARY Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 |
0.0006; 0.0124 | — |
| PRIMARY Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8 |
0.0000 | — |
| PRIMARY Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10 |
0.0000 | — |
| PRIMARY Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4 |
0.0; 0.4 | — |
| PRIMARY Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8 |
0.0 | — |
| PRIMARY Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10 |
0.0 | — |
| PRIMARY Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study |
416.2; 437.4; 397.3; 551.2; 595.1; 512.8 | — |
| PRIMARY Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study |
155.1; 157.3; 153.2; 176.9; 184.5; 170.2 | — |
| PRIMARY Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study |
70.3; 71.3; 69.3; 77.6; 82.5; 73.4 | — |
| PRIMARY Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study |
80.8; 80.5; 81.1; 81.0; 85.3; 77.4 | — |
| PRIMARY Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study |
60.9; 59.6; 62.0; 65.9; 69.7; 62.7 | — |
| PRIMARY Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study |
64.3; 60.7; 67.0; 64.3; 68.9; 61.1 | — |
| PRIMARY Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study |
56.7; 56.1; 57.2; 45.9; 49.6; 43.5 | — |
| PRIMARY Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study |
46.9; 45.7; 47.7; 42.3; 45.2; 40.4 | — |
| PRIMARY Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study |
98.4; 98.7; 98.1; 98.1; 98.5; 97.7 | — |
| PRIMARY Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study |
98.7; 98.6; 98.7; 98.8; 99.3; 98.3 | — |
| PRIMARY Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study |
89.3; 89.5; 89.2; 92.4; 94.0; 90.9 | — |
| PRIMARY Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study |
91.5; 92.0; 91.1; 95.5; 96.7; 94.3 | — |
| PRIMARY Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study |
85.6; 86.2; 85.1; 92.0; 93.8; 90.4 | — |
| PRIMARY Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study |
89.1; 89.4; 88.9; 92.1; 94.4; 90.4 | — |
| PRIMARY Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study |
84.7; 85.0; 84.6; 85.0; 90.7; 80.8 | — |
| PRIMARY Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study |
78.7; 79.0; 78.5; 85.0; 86.7; 83.8 | — |
| SECONDARY Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer |
0.0; 0.9 | — |
| SECONDARY Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4 |
0.0000; 0.0055 | — |
| SECONDARY Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8 |
0.0000 | — |
| SECONDARY Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10 |
0.0000 | — |
| SECONDARY Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4 |
0.0; 0.2 | — |
| SECONDARY Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8 |
0.0 | — |
| SECONDARY Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10 |
0.0 | — |
| SECONDARY Incidence Rate of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer |
— | — |
Eligibility Criteria
Inclusion Criteria
- No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN)
- Not pregnant and agrees to use effective contraception through Month 7 of the study
- Additional criteria applied
Exclusion Criteria
- Pregnant
- Concurrently enrolled in a clinical study involving collection of cervical specimens
- Previously received any HPV vaccine
- History of severe allergic reaction that required medical intervention
- Received any immune globulin or blood-derived products within 3 months prior to the first study injection
- History of splenectomy, known immune disorders, or receiving immunosuppressives
- Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection
- Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections
- History of recent or ongoing alcohol or drug abuse
- Prior treatment for genital warts, VIN, or VaIN
- History of cervical disease (ie, surgical treatment for cervical lesions)
- Hysterectomy
Data sourced from ClinicalTrials.gov (NCT00090220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.