Trial · NCT01610414
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
NCT01610414, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A. Trials, record NCT01610414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01610414
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
- NCT number
- NCT01610414
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,877 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Herpes Zoster
- Interventions
- Herpes Zoster vaccine GSK1437173A, Placebo
- First posted
- 2012-06-04
- Last updated
- 2018-01-23
- Other registries' IDs
- eudract:2012-000138-20
- Results first posted
- 2018-01-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | A suspected case of HZ was defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of VZV infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings\* suggestive of VZV infection in the absence of characteristic HZ or VZV rash. A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise. |
| 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 | Duration of HZ-associated pain rated as 3 or greater on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) question, following the onset of a confirmed HZ rash over the entire pain reporting period in subjects with confirmed HZ; presented as T (day) \[=the sum of follow-up period (for subjects without severe worst pain T is 1, for subjects with severe worst pain T is the duration of severe worst pain) expressed in days\]. |
| 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) | This analysis excluded complications that were linked to a confirmed HZ case that occurred after the start of the relapse treatment. |
| Secondary | Number of Subjects With Postherpetic Neuralgia (PHN) | From Month 0 until study end (21 months median follow-up) | This analysis excluded PHN episodes that were linked to a confirmed HZ case that occurred after the start of the relapse treatment. |
| Secondary | Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects | At Months 0, 1, 2, 13 and 25 | Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU/mL. |
| 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 | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| 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 | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary/tympanic temperature equal to or above 37.5 degrees Celsius (°C) or rectal temperature equal to or above 38.0 °C\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 30-day (Days 0-29) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Secondary | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | From Month 0 up to 365 days post last vaccination | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. |
| 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) | Relapse was defined as the occurrence of the underlying malignancy or disease for which the HCT was undertaken. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group186
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Confirmed Herpes Zoster (HZ) Episode | GSK1437173A Group | 49 | Participants | ||
| Number of Subjects With Confirmed Herpes Zoster (HZ) Episode | Placebo Group | 135 | Participants | ||
| Duration of 'Worst' HZ-associated Pain | GSK1437173A Group | 892.0 | T (day) | ||
| Duration of 'Worst' HZ-associated Pain | Placebo Group | 6275.0 | T (day) | ||
| Number of Subjects With Confirmed HZ-associated Complications | GSK1437173A Group | 3 | Participants | ||
| Number of Subjects With Confirmed HZ-associated Complications | Placebo Group | 13 | Participants | ||
| Number of Subjects With Postherpetic Neuralgia (PHN) | GSK1437173A Group | 1 | Participants | ||
| Number of Subjects With Postherpetic Neuralgia (PHN) | Placebo Group | 9 | Participants | ||
| Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects | GSK1437173A Group | Anti-gE, Month 0 | 762.8 | 95% Confidence Interval 568.6 to 1023.5 | mIU/mL |
| Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects | Placebo Group | Anti-gE, Month 0 | 555.0 | 95% Confidence Interval 404.3 to 761.8 | mIU/mL |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Start - Month 13 | STARTED | GSK1437173A Group | 922 | |
| Study Start - Month 13 | STARTED | Placebo Group | 924 | |
| Study Start - Month 13 | COMPLETED | GSK1437173A Group | 807 | |
| Study Start - Month 13 | COMPLETED | Placebo Group | 795 | |
| Study Start - Month 13 | NOT COMPLETED | GSK1437173A Group | 115 | |
| Study Start - Month 13 | NOT COMPLETED | Placebo Group | 129 | |
| Month 13 - Month 25 | STARTED | GSK1437173A Group | 922 | |
| Month 13 - Month 25 | STARTED | Placebo Group | 924 | |
| Month 13 - Month 25 | COMPLETED | GSK1437173A Group | 857 | |
| Month 13 - Month 25 | COMPLETED | Placebo Group | 854 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events760
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chills | General disorders | GSK1437173A Group | 238 | 922 | 303 |
| other | Chills | General disorders | Placebo Group | 117 | 924 | 134 |
| other | Erythema | Skin and subcutaneous tissue disorders | GSK1437173A Group | 304 | 922 | 422 |
| other | Erythema | Skin and subcutaneous tissue disorders | Placebo Group | 11 | 924 | 11 |
| other | Fatigue | General disorders | GSK1437173A Group | 509 | 922 | 754 |
| other | Fatigue | General disorders | Placebo Group | 341 | 924 | 496 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | GSK1437173A Group | 238 | 922 | 293 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Placebo Group | 185 | 924 | 235 |
| other | Headache | Nervous system disorders | GSK1437173A Group | 304 | 922 | 391 |
| other | Headache | Nervous system disorders | Placebo Group | 170 | 924 | 215 |
1 to 10 of 760Source ClinicalTrials.gov
See all 760 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK1437173A Group | 118 | 922 |
| Total, all-cause mortality | Placebo Group | 124 | 924 |
| Total, other adverse events | GSK1437173A Group | 813 | 922 |
| Total, other adverse events | Placebo Group | 485 | 924 |
| Total, serious adverse events | GSK1437173A Group | 329 | 922 |
| Total, serious adverse events | Placebo Group | 310 | 924 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK1437173A Group vs Placebo Group: Number of Subjects With Postherpetic Neuralgia (PHN) | Trial comparisons |
| GSK1437173A Group vs Placebo Group: Number of Subjects With Any Relapse | Trial comparisons |
| GSK1437173A Group vs Placebo Group: Number of Subjects With Confirmed Herpes Zoster (HZ) Episode | Trial comparisons |
| GSK1437173A Group vs Placebo Group: Number of Subjects With Confirmed HZ-associated Complications | Trial comparisons |
| GSK1437173A Group vs Placebo Group: deaths from any cause | Trial comparisons |
| GSK1437173A Group vs Placebo Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01610414
GET https://conductscience.org/api/trials/v1/NCT01610414/results?page=2