Phase 3
N=1,781
A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
Human · Papillomavirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00092547 ↗Enrolled (actual)
1,781
Serious AEs
0.4%
Results posted
May 2010
Primary outcome: Primary: Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 — 6; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V501 (Biological); Comparator: Placebo (Biological)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 |
6; 0 | — |
| PRIMARY Number of Participants Reporting SAEs From Month 18 Through Month 37 |
0; 3 | — |
| PRIMARY Number of Participants Reporting Other (Non-serious) AEs Through Month 18 |
918; 340 | — |
| PRIMARY Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 |
93.3; 91.4; 96.0; 96.7; 97.9; 97.4 | — |
| PRIMARY Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 |
118.9; 113.9; 135.7; 137.9; 521.2; 485.8 | — |
| PRIMARY Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 |
71.4; 91.0; 67.5; 90.3; 325.5; 387.4 | — |
| PRIMARY Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 |
88.2; 91.5; 89.1; 93.6; 96.9; 97.9 | — |
| PRIMARY Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 |
88.0; 99.3; 74.6; 96.0; 320.1; 351.6 | — |
| PRIMARY Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 |
89.0; 91.1; 88.8; 92.9; 96.0; 96.5 | — |
| PRIMARY Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up |
0; 1 | — |
| SECONDARY Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) |
99.8; 99.8; 99.7; 99.7 | — |
| SECONDARY Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18). |
97.8; 99.3; 99.6; 91.6 | — |
| SECONDARY Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) |
95.1; 98.2; 98.4; 87.5 | — |
| SECONDARY Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) |
95.6; 97.5; 98.6; 84.3 | — |
| SECONDARY Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). |
94.5; 96.0; 98.2; 81.1 | — |
| SECONDARY Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) |
99.6; 100; 100; 98.8 | — |
| SECONDARY Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) |
929.2; 1362.8; 5512.7; 1278.9 | — |
| SECONDARY Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) |
219.3; 296.9; 1314.8; 203.0 | — |
| SECONDARY Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) |
143.5; 206.6; 932.1; 136.2 | — |
| SECONDARY Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) |
146.5; 177.0; 826.1; 114.7 | — |
| SECONDARY Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) |
128.6; 149.7; 680.4; 102.4 | — |
| SECONDARY Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) |
768.6; 1041.0; 4312.7; 830.1 | — |
| SECONDARY Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females |
0.2; 0.2 | — |
| SECONDARY Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males |
0.6; 0.3 | — |
Summary
This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).
Eligibility Criteria
Inclusion Criteria
- Healthy adolescents and preadolescents with no prior sexual history
Exclusion Criteria
- Subjects with compromised immune system or have a history of severe allergic reaction
Data sourced from ClinicalTrials.gov (NCT00092547). 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.