Trial · NCT00294047
Outcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | Up to Month 48 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | Up to Month 48 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | Up to Month 84 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | Up to Month 84 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Up to Month 48 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Up to Month 48 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Up to Month 48 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Up to Month 48 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to Month 48 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to Month 48 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to Month 48 | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status | Up to Month 48 | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | Up to Month 48 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | Up to Month 48 | The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy | Up to Month 48 | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With First Colposcopy | Up to Month 48 | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | Up to Month 48 | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | Up to Month 48 | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 | The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 | The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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