11, 16, 18, 31, 33, 45, 52, and 58, Prevention of persistent anogenital HPV infection and disease caused by HPV Types 6
Conditions
Brief summary
Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay at 4 Weeks Post Last Vaccination, Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event, Percentage of Participants With at Least 1 Systemic Adverse Event, Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event
Detailed description
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 4 Weeks Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12 Months Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 24 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 24 Months Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 36 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 36 Months Post Last Vaccination
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay at 4 Weeks Post Last Vaccination, Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event, Percentage of Participants With at Least 1 Systemic Adverse Event, Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 4 Weeks Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12 Months Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 24 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 24 Months Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 36 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 36 Months Post Last Vaccinatio | — |
Countries
Poland