Adults 9 to 45, any sex, with Papillomavirus Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7
Measured GMT of anti-HPV 6, 11, 16 and 18 at Day 1 and Month 7 (1 month after completion of administration of a 6-month 3-dose regimen of vaccines). GMT at Day 1 was used to define per-protocol population. Antibody titers were tested with Luminex array.
The numeric values for the Day 1 (Vaccine and Placebo groups) and the Month 7 (Placebo groups) are the threshold of detection for the Luminex array assays. The reported values are all below the lower limit of qualification, ((less than) \<7, \<8, \<11, \<10 respectively)
anti-HPV 6
Group
Value
95% CI
Vaccine (Gardasil®) Group (Day 1)
7
7 – 7
Placebo Group (Day 1)
7
7 – 7
Vaccine (Gardasil®) Group (Month 7)
426.0
369.5 – 491.0
Placebo Group (Month 7)
7
7 – 7
anti-HPV 11
Group
Value
95% CI
Vaccine (Gardasil®) Group (Day 1)
8
8 – 8
Placebo Group (Day 1)
8
8 – 8
Vaccine (Gardasil®) Group (Month 7)
665.0
589.4 – 750.3
Placebo Group (Month 7)
8
8 – 8
anti-HPV 16
Group
Value
95% CI
Vaccine (Gardasil®) Group (Day 1)
11
11 – 11
Placebo Group (Day 1)
11
11 – 11
Vaccine (Gardasil®) Group (Month 7)
2336.9
2023.1 – 2699.3
Placebo Group (Month 7)
11
11 – 11
anti-HPV 18
Group
Value
95% CI
Vaccine (Gardasil®) Group (Day 1)
10
10 – 10
Placebo Group (Day 1)
10
10 – 10
Vaccine (Gardasil®) Group (Month 7)
535.6
461.8 – 621.2
Placebo Group (Month 7)
10
10 – 10
Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7Secondary· Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination and Month 7
Anti-HPV 6, 11, 16, 18 Seroconversion Rate, i.e., the Number of participants who were seronegative at baseline and developed seropositive at Month 7. Seroconversion for HPV 6, 11, 16, and 18 is defined as achieving an anti-HPV cLIA level of at least 20, 16, 20 and 24 mMU/mL, respectively.
Seroconversion rate = (number of participants with seronegative at baseline and developed seropositive at Month 7)/(number of participants with seronegative at baseline regardless relevant HPV serum status at Month 7). Measure serum anti-HPV 6, 11, 16, 18 titers at Day 1 prior to vaccination and at Month 7
anti-HPV 6
Group
Value
95% CI
Vaccine (Gardasil®) Group
269
Placebo Group
2
anti-HPV 11
Group
Value
95% CI
Vaccine (Gardasil®) Group
279
Placebo Group
2
anti-HPV 16
Group
Value
95% CI
Vaccine (Gardasil®) Group
277
Placebo Group
0
anti-HPV 18
Group
Value
95% CI
Vaccine (Gardasil®) Group
287
Placebo Group
3
Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each VaccinationSecondary· For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination
All adverse experiences were collected through 14 days following each vaccination. All participants were requested to record injection-site adverse experiences and monitor the participant's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.
Group
Value
95% CI
Vaccine (Gardasil®) Group
153
Placebo Group
131
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 1.25%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a China registration study. A randomized, double-blind, placebo-controlled immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male participants aged 9 to 15 years. Approximately 600 participants will be randomized in a 1:1 ratio to receive either vaccine or aluminum-containing placebo. Each participant received one injection at each visit at Day 1, Month 2, and Month 6. Vaccine or placebo was given as a 0.5-mL intramuscular injection. Serum will be collected from all participants to evaluate immune response against anti-Human Papillomavirus (HPV) 6/11/16/18 with Luminex Assay. At Month 2, Month 6, Month 7, subjects will be evaluated for any new medical condition or health concerns and Serious Adverse Experiences throughout the study. The primary objective is to evaluate the vaccine-induced serum anti-HPV 6, 11, 16 and 18 antibody titers following 3-dose regimen of Gardasil® compared with placebo.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 17 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00496626.