Trial · NCT01610414
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Confirmed Herpes Zoster (HZ) Episode | From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months) | The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of 'Worst' HZ-associated Pain | From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period | The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis, who developed a confirmed case of HZ prior to 1 month after the second vaccination. | T (day) | NUMBER |
| SECONDARY | Number of Subjects With Confirmed HZ-associated Complications | From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months) | The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Postherpetic Neuralgia (PHN) | From Month 0 until study end (21 months median follow-up) | The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects | At Months 0, 1, 2, 13 and 25 | The analysis was performed on the adapted According-to-Protocol (ATP) cohort for humoral immunogenicity, which included data from the ATP cohorts for humoral immunogenicity at Months 0,1,2,13 and 25. The ATP cohort for humoral immunogenicity included all subjects from humoral immunogenicity sub-cohort in ATP cohort for analysis of immunogenicity. | mIU/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered, who had filled in their symptom sheets. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered, who had filled in their symptom sheets. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 30-day (Days 0-29) post-vaccination period | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | From Month 0 up to 365 days post last vaccination | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Relapse | From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years) | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo | From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years) | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination | From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years) | The analysis was performed on the Total Enrolled Cohort. | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01610414/outcomes