Trial · NCT00534638
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | At the time of Visit 5 (at 18.5 years of age) | The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | During the 7-day post-vaccination period following each dose and across doses | The analysis was performed on the Total vaccinated cohort (TVC) - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | During the 7-day post-vaccination period following each dose and across doses | The analysis was performed on the TVC - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects | Within the 30-day post-vaccination period | This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Within 30 minutes following each vaccination dose | This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects | From Dose 1 (at Day 0) until Month 12 | This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects | From Dose 1 (at Day 0) until Month 12 | The analysis was performed on the TVC - subset of male subjects with active follow-up Month 0-Month 12 for SAEs, which included the male subjects in the Diary Card subset and the remaining Cervarix/Engerix-B A Group male subjects for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination | During the entire study period (from Day 0 up to Visit 5 [18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5) | 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 New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO) | During the entire study period (from day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5) | 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 Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | During the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5) | The analysis was performed on the total number of pregnant subjects reported, part of the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age) | The analysis was performed on the ATP cohort for immunogenicity-Immunogenicity subset, which comprised the same male study subjects from the Cervarix/Engerix-B A Group included in the Diary Card subset, plus approximately 1500 female study subjects from the same Cervarix/Engerix-B A Group, with assay results available at the considered time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | At the time of Visit 1 (Day 0), Visit 4 (at Month 7) and at the time of Visit 5 (18.5 years of age) | The analysis was performed on the ATP cohort for immunogenicity-Immunogenicity subset, which comprised the same male study subjects from the Cervarix/Engerix-B A Group included in the Diary Card subset, plus approximately 1500 female study subjects from the same Cervarix/Engerix-B A Group, with assay results available at the considered time point. | EL.U/mL | GEOMETRIC_MEAN |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT00534638/outcomes