Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT01165177 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Herpes Zoster Vaccine GSK1437173A (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Confirmed Herpes Zoster (HZ) Cases |
3; 2; 1; 6; 87; 75 | <0.0001 sig |
| SECONDARY Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) |
0; 0; 0; 0; 8; 2 | 0.0081 sig |
| SECONDARY Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain |
4; 1; 2; 7; 91; 74 | — |
| SECONDARY Number of Subjects With Confirmed HZ Episode Related Mortality |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With HZ Related Complications |
0; 0; 0; 0; 1; 3 | — |
| SECONDARY Number of Subjects With Confirmed HZ Episode Related Hospitalizations |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ |
3; 2; 1; 6; 82; 63 | — |
| SECONDARY Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ |
3; 2; 1; 6; 82; 63 | — |
| SECONDARY Number of Days With Severe 'Worst' HZ-associated Pain. |
12.0; 78.0; 9.0; 20.6; 28.7; 21.6 | — |
| SECONDARY Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With HZ Related Complications, by Complication Type |
0; 0; 0; 0; 1; 3 | — |
| SECONDARY Distribution of Pain Medication Associated With HZ |
3; 2; 1; 6; 82; 63 | — |
| SECONDARY Number of Days of Pain Medication Associated With HZ |
17.3; 20.5; 63.0; 26.0; 49.2; 74.3 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
3120; 352; 159; 6; 1225; 40 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
1395; 531; 109; 29; 1153; 355 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited) |
3766; 1691; 759; 145 | — |
| SECONDARY Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) |
87; 105; 8; 12 | — |
| SECONDARY Number of Subjects With AEs With Any and Related Medically Attended Visit |
2952; 3072; 142; 60 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
3534; 2426; 609; 298; 2199; 439 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
88; 97; 1; 3; 594; 590 | — |
| SECONDARY Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine |
43; 25 | — |
| SECONDARY Number of Subjects With Fatal SAEs |
208; 221 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes will comply with the requirements of the protocol;
- Written informed consent obtained from the subject;
- A male or female aged 50 years or older at the time of the first vaccination;
- Female subjects of non-childbearing potential may be enrolled in the study;
For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;
Exclusion Criteria
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product;
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
- History of HZ;
- Previous vaccination against varicella or HZ;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation;
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study;
- Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period;
- Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine;
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
- Acute disease and/or fever at the time of enrollment;
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Pregnant or lactating female;
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Data sourced from ClinicalTrials.gov (NCT01165177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.