Trial · NCT00090220
Outcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7 | Incidence per 100 person-years | NUMBER |
| PRIMARY | Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | Participants who received \>=1 qHPV vaccination or placebo injection in the Base Study and had safety follow-up | Participants | NUMBER |
| PRIMARY | Number of Participants With Vaccine-Related SAEs After Vaccine Administration | qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120 | Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up | Participants | NUMBER |
| PRIMARY | Number of Participants With an SAE Resulting in Death After Vaccine Administration | qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120 | Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up | Participants | NUMBER |
| PRIMARY | Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data. | Cumulative Incidence Probability | NUMBER |
| PRIMARY | Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study. | Cumulative Incidence Probability | NUMBER |
| PRIMARY | Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study. | Cumulative Incidence Probability | NUMBER |
| PRIMARY | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4 | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data. | Incidence per 100 person-years | NUMBER |
| PRIMARY | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study. | Incidence per 100 person-years | NUMBER |
| PRIMARY | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study. | Incidence per 100 person-years | NUMBER |
| PRIMARY | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | Month 7 (1 month after the third dose of qHPV vaccine in the Base Study) | Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity. | mMU/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | Month 12 (6 months after the third dose of qHPV vaccine in the Base Study) | Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity. | mMU/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | Month 24 (18 months after the third dose of qHPV vaccine in the Base Study) | Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity. | mMU/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | Month 36 (30 months after the third dose of qHPV vaccine in the Base Study) | Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity. | mMU/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | Month 48 (42 months after the third dose of qHPV vaccine in the Base Study) | Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity. | mMU/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | Month 72 (66 months after the third dose of qHPV vaccine in the Base Study) | Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity. | mMU/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | Month 96 (90 months after the third dose of qHPV vaccine in the Base Study) | Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity. | mMU/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | Month 120 (114 months after the third dose of qHPV vaccine in the Base Study) | Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity. | mMU/mL | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | Month 7 (1 month after the third dose of qHPV vaccine in the Base Study) | Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | Month 12 (6 months after the third dose of qHPV vaccine in the Base Study) | Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity. | Percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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