Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02581410 |
Recruitment Status :
Completed
First Posted : October 21, 2015
Results First Posted : September 26, 2017
Last Update Posted : August 28, 2018
|
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Condition |
Herpes Zoster |
Intervention |
Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) |
Enrollment | 430 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | GSK1437173A Group | Control Group |
---|---|---|
Arm/Group Description | Subjects above or equal to (≥) 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study. | Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study. |
Period Title: Vaccination Phase | ||
Started | 215 | 215 |
Completed | 213 | 212 |
Not Completed | 2 | 3 |
Reason Not Completed | ||
Adverse Event | 2 | 1 |
Withdrawal by Subject | 0 | 1 |
Migrated/moved from study area | 0 | 1 |
Period Title: End of Study Phase | ||
Started | 215 | 215 |
Completed | 210 | 204 |
Not Completed | 5 | 11 |
Reason Not Completed | ||
Adverse Event | 4 | 3 |
Withdrawal by Subject | 1 | 2 |
Migrated/moved from study area | 0 | 3 |
Lost to Follow-up | 0 | 2 |
Other-transfer of subject not completed | 0 | 1 |
Baseline Characteristics
Arm/Group Title | GSK1437173A Group | Control Group | Total | |
---|---|---|---|---|
Arm/Group Description | Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study. | Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study. | Total of all reporting groups | |
Overall Number of Baseline Participants | 215 | 215 | 430 | |
Baseline Analysis Population Description |
[Not Specified]
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 215 participants | 215 participants | 430 participants | |
71.1 (4.5) | 70.8 (4.6) | 70.9 (4.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 215 participants | 215 participants | 430 participants | |
Female |
109 50.7%
|
111 51.6%
|
220 51.2%
|
|
Male |
106 49.3%
|
104 48.4%
|
210 48.8%
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
||||
White - Caucasian / European Heritage | Number Analyzed | 215 participants | 215 participants | 430 participants |
White - Caucasian / European Heritage |
215 100.0%
|
215 100.0%
|
430 100.0%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT02581410 |
Other Study ID Numbers: |
201198 |
First Submitted: | October 19, 2015 |
First Posted: | October 21, 2015 |
Results First Submitted: | August 29, 2017 |
Results First Posted: | September 26, 2017 |
Last Update Posted: | August 28, 2018 |