Herpes ZosterPhase 3NCT01777321

Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Intramuscularly in Adults Aged ≥50 Years

A Phase 3 study testing Herpes zoster vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older. Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Herpes Zoster
What is being tested?: Herpes zoster vaccine GSK1437173A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteJapan
Study dates: 17 Jun 2013to 11 Nov 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Subject, residing in Japan, is of Japanese ethnic origin, defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese.
Subject has provided written informed consent.
Subject, male or female, who is 50 YOA or older at the time of the first vaccination.
Subject, if female, of non-childbearing potential may be enrolled in the study.
Subject, if female, of childbearing potential may be enrolled in the study, if the subject:

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has practiced adequate contraception for 30 days prior to vaccination, and
has a negative 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 (i.e., for 2 months after Month 2).

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating or planned participation 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.
Administration or planned administration of a live vaccine within 30 days prior to the first study vaccination through 30 days after the second study vaccination.
Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
Planned administration, during the study, of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
Administration of immunoglobulins and/or any blood products within the three (3) months preceding the first dose of study vaccine or planned administration during the study period.

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Chronic administration (defined as >14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed.
Inhaled, topical, and intra-articular corticosteroids are allowed.
Administration or planned administration of long-acting immune-modifying drugs (e.g., infliximab) within six months prior to the first vaccine dose through the duration of the study period.
History of HZ.
Previous vaccination against HZ or varicella (registered or investigational product).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
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 vaccination:
Fever is defined as temperature ≥37.5°C (99.5°F) for oral, axillary, or tympanic route, or ≥38.0°C/100.4°F for rectal route. The preferred route for recording temperature in this study will be oral.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) through Month 4 (i.e., 2 months after the second dose of study vaccine).

Trial locations and contacts

1 site in 1 country.

Japan1 site

GSK Investigational Site
Fukuoka, 812-0025

Other trials in Japan

About this study

Official title: Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Versus Intramuscularly in Adults Aged 50 Years or Older

Read the detailed description

There are 2 treatment groups in this study based upon the mode of vaccine administration.

The humoral immunogenicity (HI) will be measured in all subjects.

Conditions: Herpes Zoster
Being tested: Herpes zoster vaccine GSK1437173A
Keywords: Herpes Zoster, Intramuscular, Subcutaneous, Safety, ≥50 years of age, Adults, Immunogenicity, Elderly
Medical subject headings: Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Herpes zoster vaccine GSK1437173ABiological
HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule.

Study groups in NCT01777321
Study group	Role	What they receive
SC HZ/su Group	Experimental	Subjects will receive HZ/su vaccine administered SC on a 0,2-month schedule. Receives: Biological: Herpes zoster vaccine GSK1437173A
IM HZ/su Group	Active comparator	Subjects will receive HZ/su vaccine administered IM on a 0,2-month schedule. Receives: Biological: Herpes zoster vaccine GSK1437173A

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL)
A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL.
Measured: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)
Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.
Measured: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)
Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Measured: At two months after Dose 1 (M2) and one month after Dose 2 (M3)
Descriptive Statistics of Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay.
Measured: Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)
Number of Subjects With Solicited Local Symptoms
The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.
Measured: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.
Measured: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses
Mean Number of Days With Local Symptoms
Days with solicited local symptoms were tabulated for the total vaccinated cohort.
Measured: During the 7 day (Days 0-6) post vaccination, after each dose (D)
Mean Number of Days With General Symptoms
Days with solicited general symptoms were tabulated for the total vaccinated cohort.
Measured: During the 7 day (Days 0-6) post vaccination, after each dose (D)
Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)
Potential immune-mediated diseases (pIMDs) were 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.
Measured: From Month 0 to Month 3
Number of Subjects With Unsolicited Adverse Events (AEs)
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.
Measured: Within 30 days (Days 0-29) post vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Month 0 to Month 3

Secondary outcomes (5)

Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL
A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value of 97 mIU/mL.
Measured: At Month 14
Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were expressed as geometric mean concnetrations (GMCs) and measured in mIU/mL.
Measured: At Month 14
Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Measured: Twelve Months after Dose 2 (M14)
Number of Subjects With pIMDs
Potential immune-mediated diseases (pIMDs) were 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.
Measured: Up to Month 14 post vaccination period
Number of Subjects With SAEs
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Up to Month 14 post vaccination period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 201311 Nov 2014

First posted28 Jan 2013 (estimated)
Study start17 Jun 2013
Primary completion10 Oct 2013
Study completion11 Nov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Herpes ZosterStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01777321
Sponsor's protocol ID: 116760
Other IDs: 2012-005671-14
Status last verified: Aug 2018
First submitted: 24 Jan 2013
Last updated: 25 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
PubMed 37781954
Vink P, Shiramoto M, Ogawa M, Eda M, Douha M, Heineman T, Lal H. Safety and immunogenicity of a Herpes Zoster subunit vaccine in Japanese population aged >/=50 years when administered subcutaneously vs. intramuscularly. Hum Vaccin Immunother. 2017 Mar 4;13(3):574-578. doi: 10.1080/21645515.2016.1232787. Epub 2016 Dec 9.
PubMed 27936344

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
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RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Versus Intramuscularly in Adults Aged 50 Years or Older
ClinicalTrials.gov ID: NCT01777321
Acronym / sponsor ID: 116760
Conditions: Herpes Zoster
Keywords: Herpes Zoster, Intramuscular, Subcutaneous, Safety, ≥50 years of age, Adults, Immunogenicity, Elderly
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 17 Jun 2013
Primary completion: 10 Oct 2013 (actual)
Study completion: 11 Nov 2014 (actual)
First posted: 28 Jan 2013 (estimated)
Results: Posted 6 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

There are 2 treatment groups in this study based upon the mode of vaccine administration.

The humoral immunogenicity (HI) will be measured in all subjects.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SC HZ/su Group	Experimental	Biological: Herpes zoster vaccine GSK1437173ASubjects will receive HZ/su vaccine administered SC on a 0,2-month schedule.
IM HZ/su Group	Active comparator	Biological: Herpes zoster vaccine GSK1437173ASubjects will receive HZ/su vaccine administered IM on a 0,2-month schedule.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Subject who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Subject, residing in Japan, is of Japanese ethnic origin, defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese.
Subject has provided written informed consent.
Subject, male or female, who is 50 YOA or older at the time of the first vaccination.
Subject, if female, of non-childbearing potential may be enrolled in the study.

Key exclusion criteria (20 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating or planned participation 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.
Administration or planned administration of a live vaccine within 30 days prior to the first study vaccination through 30 days after the second study vaccination.
Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
Planned administration, during the study, of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Herpes zoster vaccine GSK1437173AHZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule.	Biological	IM HZ/su Group, SC HZ/su Group

Primary outcome

Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL)
Time frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)
A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL.
Anti-gE Antibody Concentrations
Time frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)
Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.
Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
Time frame: At two months after Dose 1 (M2) and one month after Dose 2 (M3)
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Descriptive Statistics of Anti-gE Antibody Concentrations
Time frame: Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)
Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay.
Number of Subjects With Solicited Local Symptoms
Time frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses
The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.
Number of Subjects With Solicited General Symptoms
Time frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses
Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.
Mean Number of Days With Local Symptoms
Time frame: During the 7 day (Days 0-6) post vaccination, after each dose (D)
Days with solicited local symptoms were tabulated for the total vaccinated cohort.
Mean Number of Days With General Symptoms
Time frame: During the 7 day (Days 0-6) post vaccination, after each dose (D)
Days with solicited general symptoms were tabulated for the total vaccinated cohort.
Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)
Time frame: From Month 0 to Month 3
Potential immune-mediated diseases (pIMDs) were 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.
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: Within 30 days (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.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Month 0 to Month 3
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

5 secondary outcomes

Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL
Time frame: At Month 14
Anti-gE Antibody Concentrations
Time frame: At Month 14
Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
Time frame: Twelve Months after Dose 2 (M14)
Number of Subjects With pIMDs
Time frame: Up to Month 14 post vaccination period
Number of Subjects With SAEs
Time frame: Up to Month 14 post vaccination period

Results and safety

Results posted to the registry on 6 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SC GSK1437173A Group	30	30
IM GSK1437173A Group	30	29

Primary outcome: Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL)

Time frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3). Count of participants. Unit: Participants

Measure	SC GSK1437173A Group n = 29	IM GSK1437173A Group n = 29
Anti-gE, PRE	29	29
Anti-gE, M2	29	29
Anti-gE, M3	29	29

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.

Primary outcome: Anti-gE Antibody Concentrations

Time frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3). Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	SC GSK1437173A Group n = 29	IM GSK1437173A Group n = 29
Anti-gE, PRE	1424.3 (1042.6 to 1945.6)	1116.8 (774.5 to 1610.3)
Anti-gE, M2	19902.5 (14846.9 to 26679.6)	12842 (8558.4 to 19269.7)
Anti-gE, M3	44126.1 (36326.1 to 53601)	45521.5 (37549.5 to 55185.9)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.

Primary outcome: Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations

Time frame: At two months after Dose 1 (M2) and one month after Dose 2 (M3). Count of participants. Unit: Participants

Measure	SC GSK1437173A Group n = 29	IM GSK1437173A Group n = 29
Anti-gE, M2	28	25
Anti-gE, M3	29	29

Primary outcome: Descriptive Statistics of Anti-gE Antibody Concentrations

Time frame: Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3). Median (Standard Deviation). Unit: mIU/mL

Measure	SC GSK1437173A Group n = 29	IM GSK1437173A Group n = 29
Anti-gE, PRE	1404.1 (1398.82)	946.3 (3231.78)
Anti-gE, M2	19400.1 (24456.86)	14330.1 (14548.75)
Anti-gE, M3	44182 (27990.99)	42444.8 (27555.21)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms: during the 7-day post-vaccination period; Unsolicited AEs: during the 30-day post-vaccination period; SAEs: up to Month 14 post vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SC GSK1437173A Group	2 of 30 (6.7%)	30 of 30 (100%)	0 of 30
IM GSK1437173A Group	1 of 30 (3.3%)	28 of 30 (93.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37781954de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
Derived from this study: PubMed 27936344Vink P, Shiramoto M, Ogawa M, Eda M, Douha M, Heineman T, Lal H. Safety and immunogenicity of a Herpes Zoster subunit vaccine in Japanese population aged >/=50 years when administered subcutaneously vs. intramuscularly. Hum Vaccin Immunother. 2017 Mar 4;13(3):574-578. doi: 10.1080/21645515.2016.1232787. Epub 2016 Dec 9.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Herpes Zoster

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Herpes zoster vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) (time frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01777321, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.