Trial · NCT00779766
Outcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | At Month 24 | The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable subjects for whom efficacy data were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | At Month 48 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | At Month 57 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | At Month 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | At Months 24,48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | At Months 24,48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Within 7 days (Days 0-6) after vaccination | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Within 7 days (Days 0-6) after vaccination | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Within 7 days (Days 0-6) after vaccination | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Within 7 days (Days 0-6) after vaccination | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
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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