Prevention of : Herpes-ZosterPhase 3NCT00561080
Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)
A Phase 3 study testing Zostavax in people with Prevention of : Herpes-Zoster, run by Merck Sharp & Dohme LLC.
Trial summary
Primary objective: Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination Secondary… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention of : Herpes-Zoster
- What is being tested?
- Zostavax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 759 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2007to 3 Jun 2009
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 70 years
- Varicella history-positive or residence for > 30 years in a country with endemic VZV infection
- Signed informed consent form prior to any study procedure
Who cannot join
- Febrile illness within the last 72 hours before the first vaccination
- Prior herpes-zoster episode clinically diagnosed by a physician
- Prior receipt of varicella or zoster vaccine
- Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
- Significant underlying illness preventing completion of the study vaccination schedules,
- Known active tuberculosis,
Show all 12Show fewer
- Immune deficiency disorder, including active neoplastic disease within the prior 5 years,
- Immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause,
- Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination,
- Receipt of any other live vaccine within the 4 weeks prior to the first vaccination,
- Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination,
- Concomitant use of non-topical antiviral therapy
About this study
Official title: An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of a 1-dose Regimen and Different 2-dose Regimens of a Zoster Vaccine (Live), ZOSTAVAX ®, in Subjects ≥ 70 Years of Age
Primary objective:
Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination
Read more
Secondary objectives Immunogenicity
- To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®.
- To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX®
- To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®
- Conditions
- Prevention of : Herpes-Zoster
- Being tested
- Zostavax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZostavaxBiological
Also called Zoster vaccine live
| Study group | Role | What they receive |
|---|---|---|
| Single Dose of Zostavax | Experimental | Zostavax 0.65mL intramuscular injection administered on Day 0 Receives: Biological: Zostavax |
| Zostavax - Day 0 and Month 1 | Experimental | Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 1 Receives: Biological: Zostavax |
| Zostavax - Day 0 and Month 3 | Experimental | Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 3 Receives: Biological: Zostavax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3
Blood samples taken at 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).
Measured: 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)
Secondary outcomes (22)
Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1
Blood sample taken at 4 weeks post vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA.
Measured: 4 weeks post-dose (Month 1)
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3
Blood sample taken at predose (Day 0) and 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The GMFR was calculated following each vaccination as GMT Post-dose/GMT Pre-vaccination
Measured: Predose and 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)
Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose
Blood sample taken at 1 year post last vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.
Measured: 1 year post final dose for Groups 1, 2, and 3 (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 12 Months Post-dose 1 in Group 1 And From Pre-Vaccination To 12 Months Post-dose 2 in Groups 2 and 3
Blood sample taken at predose and 1 year post last vaccination to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was calculated for each arm as GMT 12-month post last dose divided by pre-vaccination GMT.
Measured: predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)
Geometric Mean Titre (GMT) of VZV Antibodies 24 and 36 Months Post-dose 1 in Group 1 and the 24 and 36 Months Post-dose 2 in Groups 2 and 3
Blood sample taken at 36 months post last-vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.
Measured: 24 and 36 months post-last dose
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 24 And 36 Months Post-dose 1 in Group 1 and From Pre-vaccination To 24 And 36 Months Post-dose 2 in Groups 2 and 3
Blood samples were to be taken at predose and 24 months post- last vaccination in Groups 1 , 2, and 3 to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was to be calculated for each arm as GMT 24-month post last dose divided by pre-vaccination GMT.
Measured: Predose 1 and 24 and 36 months post-last dose
Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1
Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain
Measured: up to 4 days after 1st vaccination
Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2
Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain
Measured: up to 4 days after 2nd vaccination
Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1
The percentage of participants who reported an injection site reaction that was not specifically prompted by the diary card within 28 day of 1st vaccination was recorded.
Measured: up to 28 days after 1st of study drug
Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2
The percentage of participants that reported an injection site reaction that was not specifically prompted by the diary card within 28 days post-dose 2 was recorded.
Measured: up to 28 days post-dose 2
Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1
Percentage of participants who reported herpes zoster or zoster-like rash following the 1st dose of vaccine were recorded.
Measured: up to 28 days post-dose 1
Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2
Percentage of participants who reported herpes zoster or zoster-like rash following the 2nd dose of vaccine were recorded.
Measured: up to 28 days post-dose 2
Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1
Percentage of participants that reported varicella or varicella-like rash following the 1st dose of vaccine were recorded.
Measured: up to 28 days post-dose 1
Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2
Percentage of participants that reported varicella or varicella-like rash following the 2nd dose of vaccine were recorded.
Measured: up to 28 days post-dose 2
Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1
An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized
Measured: up to 28 days after 1st vaccination
Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2
An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized,
Measured: up to 28 days after 2nd vaccination
Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1
An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) and were reported as at least possibly related to the vaccine were summarized
Measured: up to 28 days after 1st vaccination
Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2
An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) and were reported as at least possibly related to the vaccine were summarized,
Measured: up to 28 days after 2nd vaccination
Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1
A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. The percentage of participants who reported an SAE within 28 days of 1st dose of vaccine were recorded.
Measured: up to 28 days after 1st vaccination
Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2
A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. The percentage of participants who reported an SAE within 28 days of 1st dose of vaccine were recorded.
Measured: up to 28 days after 2nd vaccination
Percentage of Participants Who Reported a Vaccine-related Serious Adverse Event
A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. The percentage of participants who reported an SAE during the entire study period that was considered at least possibly -related to the vaccine were recorded.
Measured: up to end of study (approximately 15 months)
Percentage of Participants Who Died During the Study
The number of participants who died for any reason during the study was summarized.
Measured: up to end of study (approximately 15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study start26 Oct 2007
- Primary completion3 Jun 2009
- Study completion3 Jun 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of : Herpes-ZosterStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561080
- Sponsor's protocol ID
- V211-043
- Other IDs
- X06-Z-305, 2007-000744-28
- Status last verified
- Dec 2018
- First submitted
- 19 Nov 2007
- Last updated
- 11 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Vesikari T, Hardt R, Rumke HC, Icardi G, Montero J, Thomas S, Sadorge C, Fiquet A. Immunogenicity and safety of a live attenuated shingles (herpes zoster) vaccine (Zostavax(R)) in individuals aged >/= 70 years: a randomized study of a single dose vs. two different two-dose schedules. Hum Vaccin Immunother. 2013 Apr;9(4):858-64. doi: 10.4161/hv.23412. Epub 2013 Jan 14.
PubMed 23319176
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of a 1-dose Regimen and Different 2-dose Regimens of a Zoster Vaccine (Live), ZOSTAVAX ®, in Subjects ≥ 70 Years of Age
- ClinicalTrials.gov ID
- NCT00561080
- Acronym / sponsor ID
- V211-043
- Conditions
- Prevention of : Herpes-Zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 759 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2007 (actual)
- Primary completion
- 3 Jun 2009 (actual)
- Study completion
- 3 Jun 2009 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Posted 22 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination
Secondary objectives Immunogenicity
- To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®.
- To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX®
- To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Dose of Zostavax | Experimental | Biological: ZostavaxZostavax 0.65mL intramuscular injection administered on Day 0 |
| Zostavax - Day 0 and Month 1 | Experimental | Biological: ZostavaxZostavax 0.65mL intramuscular injection administered on Day 0 and Month 1 |
| Zostavax - Day 0 and Month 3 | Experimental | Biological: ZostavaxZostavax 0.65mL intramuscular injection administered on Day 0 and Month 3 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 70 years
- Varicella history-positive or residence for > 30 years in a country with endemic VZV infection
- Signed informed consent form prior to any study procedure
Key exclusion criteria (12 listed)
- Febrile illness within the last 72 hours before the first vaccination
- Prior herpes-zoster episode clinically diagnosed by a physician
- Prior receipt of varicella or zoster vaccine
- Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
- Significant underlying illness preventing completion of the study vaccination schedules,
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 |
|---|---|---|
| ZostavaxAlso: Zoster vaccine live | Biological | Single Dose of Zostavax, Zostavax - Day 0 and Month 1, Zostavax - Day 0 and Month 3 |
Primary outcome
Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3
Time frame: 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)
Blood samples taken at 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).
22 secondary outcomes
Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1
Time frame: 4 weeks post-dose (Month 1)
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3
Time frame: Predose and 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)
Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose
Time frame: 1 year post final dose for Groups 1, 2, and 3 (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 12 Months Post-dose 1 in Group 1 And From Pre-Vaccination To 12 Months Post-dose 2 in Groups 2 and 3
Time frame: predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)
Geometric Mean Titre (GMT) of VZV Antibodies 24 and 36 Months Post-dose 1 in Group 1 and the 24 and 36 Months Post-dose 2 in Groups 2 and 3
Time frame: 24 and 36 months post-last dose
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 24 And 36 Months Post-dose 1 in Group 1 and From Pre-vaccination To 24 And 36 Months Post-dose 2 in Groups 2 and 3
Time frame: Predose 1 and 24 and 36 months post-last dose
Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1
Time frame: up to 4 days after 1st vaccination
Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2
Time frame: up to 4 days after 2nd vaccination
Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1
Time frame: up to 28 days after 1st of study drug
Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2
Time frame: up to 28 days post-dose 2
Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1
Time frame: up to 28 days post-dose 1
Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2
Time frame: up to 28 days post-dose 2
Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1
Time frame: up to 28 days post-dose 1
Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2
Time frame: up to 28 days post-dose 2
Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1
Time frame: up to 28 days after 1st vaccination
Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2
Time frame: up to 28 days after 2nd vaccination
Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1
Time frame: up to 28 days after 1st vaccination
Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2
Time frame: up to 28 days after 2nd vaccination
Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1
Time frame: up to 28 days after 1st vaccination
Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2
Time frame: up to 28 days after 2nd vaccination
Percentage of Participants Who Reported a Vaccine-related Serious Adverse Event
Time frame: up to end of study (approximately 15 months)
Percentage of Participants Who Died During the Study
Time frame: up to end of study (approximately 15 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23319176Vesikari T, Hardt R, Rumke HC, Icardi G, Montero J, Thomas S, Sadorge C, Fiquet A. Immunogenicity and safety of a live attenuated shingles (herpes zoster) vaccine (Zostavax(R)) in individuals aged >/= 70 years: a randomized study of a single dose vs. two different two-dose schedules. Hum Vaccin Immunother. 2013 Apr;9(4):858-64. doi: 10.4161/hv.23412. Epub 2013 Jan 14.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Related trials for Prevention of : Herpes-Zoster
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 4
Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia
Cardiovascular Disease, Dementia
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
RecruitingPhase 1/2
A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
Herpes Zoster
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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zostavax in people with Prevention of : Herpes-Zoster, run by Merck Sharp & Dohme LLC.
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 3 inclusion and 12 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 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 22 Dec 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?
Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (time frame: 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)). 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 NCT00561080, which also lists 1 linked publication.
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 11 Jan 2019.