Trial Outcomes & Findings for Month 30 & 42 Extension Studies of CRD-004 Primary Study (NCT NCT00492648)

NCT ID: NCT00492648

Last Updated: 2019-06-26

Results Overview

The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, and CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: At Month 30 after the first vaccination.
• Results posted on: 2019-06-26

Participant Flow

Participant milestones

Measure	GSK1437173A 18-30 Years Old Group Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Month 30 (109671 Study) STARTED	4	30
Month 30 (109671 Study) COMPLETED	4	29
Month 30 (109671 Study) NOT COMPLETED	0	1
Month 42 (109674 Study) STARTED	3	20
Month 42 (109674 Study) COMPLETED	3	20
Month 42 (109674 Study) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	GSK1437173A 18-30 Years Old Group Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Month 30 (109671 Study) Protocol Violation	0	1

Baseline Characteristics

For Month 30 (109671 Study)

Baseline characteristics by cohort

Measure	GSK1437173A 18-30 Years Old Group n=4 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=30 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.	Total n=34 Participants Total of all reporting groups
Age, Continuous	22.7 Years STANDARD_DEVIATION 3.79 • n=3 Participants • For Month 42 (109674 Study)	56.0 Years STANDARD_DEVIATION 4.59 • n=20 Participants • For Month 42 (109674 Study)	51.6 Years STANDARD_DEVIATION 12.28 • n=23 Participants • For Month 42 (109674 Study)
Sex: Female, Male Female	3 Participants n=3 Participants • For Month 42 (109674 Study)	16 Participants n=20 Participants • For Month 42 (109674 Study)	19 Participants n=23 Participants • For Month 42 (109674 Study)
Sex: Female, Male Male	0 Participants n=3 Participants • For Month 42 (109674 Study)	4 Participants n=20 Participants • For Month 42 (109674 Study)	4 Participants n=23 Participants • For Month 42 (109674 Study)
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: At Month 30 after the first vaccination.

Population: The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.

The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, and CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected.

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=4 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=29 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L).	NA gE-specific CD4 cells/million CD4 cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4).	1184.7 gE-specific CD4 cells/million CD4 cells Standard Deviation 925.8

PRIMARY outcome

Timeframe: At Month 30 after the first vaccination

Population: The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.

The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected.

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=4 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=29 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).	NA VZV-specific CD4 cells/million CD4 cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4).	707.4 VZV-specific CD4 cells/million CD4 cells Standard Deviation 533.1

PRIMARY outcome

Timeframe: At Month 42 after the first vaccination

Population: The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.

The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected.

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=3 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=20 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).	NA gE-specific CD4 cells/million CD4 cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 3).	899.8 gE-specific CD4 cells/million CD4 cells Standard Deviation 844.4

PRIMARY outcome

Timeframe: At Month 42 after the first vaccination

Population: The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.

The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected.

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=3 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=20 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).	NA VZV-specific CD4 cells/million CD4 cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 3).	723.8 VZV-specific CD4 cells/million CD4 cells Standard Deviation 816.4

SECONDARY outcome

Timeframe: At Months 30 and 42 after the first vaccination

Population: The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.

The analysis focused on those gE- and VZV-specific CD4 T cells secreting any cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE or VZV was performed, since no long-term vaccine effect on gE- and VZV-specific CD8 T cell response was detected.

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=4 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=29 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. gE, TNF-α and IFN-γ/IL-2/CD40L, Month 30	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	806.4 CD4 cells/million T-cells Standard Deviation 721.1
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. gE, CD40L and IFN-γ/IL-2/TNF-α, Month 30	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	1173.8 CD4 cells/million T-cells Standard Deviation 918.6
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. gE, IL-2 and IFN-γ/TNF-α/CD40L, Month 42	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	896.9 CD4 cells/million T-cells Standard Deviation 822.9
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. gE, TNF-α and IFN-γ/IL-2/CD40L, Month 42	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	506.5 CD4 cells/million T-cells Standard Deviation 550.8
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. VZV, IFN-γ and IL-2/TNF-α/CD40L, Month 30	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	467.1 CD4 cells/million T-cells Standard Deviation 349.9
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. VZV, IL-2 and IFN-γ/TNF-α/CD40L, Month 42	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	631.5 CD4 cells/million T-cells Standard Deviation 694.6
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. VZV, TNF-α and IFN-γ/IL-2/CD40L, Month 42	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	556.1 CD4 cells/million T-cells Standard Deviation 629.9
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. gE, IL-2 and IFN-γ/TNF-α/CD40L, Month 30	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	1144.8 CD4 cells/million T-cells Standard Deviation 912.2
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. gE, IFN-γ and IL-2/TNF-α/CD40L, Month 30	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	574.2 CD4 cells/million T-cells Standard Deviation 402.7
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. gE, IFN-γ and IL-2/TNF-α/CD40L, Month 42	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	531.5 CD4 cells/million T-cells Standard Deviation 533.3
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. gE, CD40L and IFN-γ/IL-2/TNF-α, Month 42	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	855.5 CD4 cells/million T-cells Standard Deviation 769.7
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. VZV, IL-2 and IFN-γ/TNF-α/CD40L, Month 30	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	654.2 CD4 cells/million T-cells Standard Deviation 494.0
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. VZV, TNF-α and IFN-γ/IL-2/CD40L, Month 30	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	528.0 CD4 cells/million T-cells Standard Deviation 417.3
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. VZV, CD40L and IFN-γ/IL-2/TNF-α, Month 30	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	694.2 CD4 cells/million T-cells Standard Deviation 518.3
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. VZV, IFN-γ and IL-2/TNF-α/CD40L, Month 42	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	542.0 CD4 cells/million T-cells Standard Deviation 682.1
Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. VZV, CD40L and IFN-γ/IL-2/TNF-α, Month 42	NA CD4 cells/million T-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	617.3 CD4 cells/million T-cells Standard Deviation 743.6

SECONDARY outcome

Timeframe: At months 30 and 42 after the first vaccination

Population: The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.

As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=4 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=29 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Anti-gE Antibody (Ab) Concentrations At Month 30	4008.9 EL.U/mL Interval 2048.0 to 7847.1	3390.1 EL.U/mL Interval 2684.9 to 4280.6
Anti-gE Antibody (Ab) Concentrations At Month 42	3662.2 EL.U/mL Interval 905.6 to 14809.0	2413.1 EL.U/mL Interval 1698.8 to 3427.8

SECONDARY outcome

Timeframe: At months 30 and 42 after the first vaccination

Population: The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.

As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=4 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=29 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Anti-VZV Ab Concentrations At Month 30	5341.8 EL.U/mL Interval 2247.8 to 12694.5	4049.3 EL.U/mL Interval 3340.0 to 4909.2
Anti-VZV Ab Concentrations At Month 42	3988.2 EL.U/mL Interval 753.2 to 21115.9	2683.3 EL.U/mL Interval 1991.2 to 3615.9

SECONDARY outcome

Timeframe: At months 30 and 42 after the first vaccination

Population: The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.

As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=4 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=29 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Frequencies of gE-specific Memory B Cells At Month 30	NA gE-specific B-cells/million B-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	3614.2 gE-specific B-cells/million B-cells Standard Deviation 2389.8
Frequencies of gE-specific Memory B Cells At Month 42	NA gE-specific B-cells/million B-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	2696.1 gE-specific B-cells/million B-cells Standard Deviation 2644.0

SECONDARY outcome

Timeframe: At months 30 and 42 after the first vaccination

Population: The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.

As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=4 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=29 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Frequencies of VZV-specific Memory B Cells At Month 30	NA VZV-specific B-cells/million B-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	4853.8 VZV-specific B-cells/million B-cells Standard Deviation 3362.1
Frequencies of VZV-specific Memory B Cells At Month 42	NA VZV-specific B-cells/million B-cells Standard Deviation NA Descriptive statistics on immune persistence data in the GSK1437173A 18-30 Years Old Group were not performed, since the number of enrolled subjects in this age cohort was too low (N = 4 at M30 and N = 3 at M42).	3488.1 VZV-specific B-cells/million B-cells Standard Deviation 2689.1

SECONDARY outcome

Timeframe: From Month 30 to study end Month 42 after the first vaccination

Population: The analysis was performed on the Total cohort for persistence which included all subjects previously primed with 2 doses of GSK1437173A and were enrolled in the current study.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=4 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=30 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Number of Subjects With Any Serious Adverse Events (SAEs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From last primary study visit (Month 12) to study end at Month 42 after the first vaccination.

Population: The analysis was performed on the Total cohort for persistence which included all subjects previously primed with 2 doses of GSK1437173A and were enrolled in the current study.

This assay tabulated the number of subjects with clinically diagnosed HZ episodes, defined as any cutaneous HZ-like rash.

Outcome measures

Measure	GSK1437173A 18-30 Years Old Group n=4 Participants Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.	GSK1437173A 50-70 Years Old Group n=30 Participants Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes	0 Participants	0 Participants

Adverse Events

GSK1437173A 18-30 Years Old Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GSK1437173A 50-70 Years Old Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER