Herpes ZosterPhase 4NCT00550745

ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)

A Phase 4 study testing Zoster Vaccine, Live in people with Herpes Zoster, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Herpes Zoster
What is being tested?: Zoster Vaccine, Live
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11,999 participants
Where: No sites listed yet
Study dates: Sep 2007to Jan 2009
Phase: Phase 4
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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

60+ years of Age
Signed an informed consent prior to the start of study
Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination
Females must be postmenopausal or have a negative pregnancy test

Who cannot join

A history of allergic reaction to any vaccine component (including gelatin or neomycin)
Prior receipt of any varicella or zoster vaccine
Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination
Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination
Subject is pregnant or breastfeeding
Participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination

Show all 10Show fewer

An ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study
Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation
Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible
Any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir

About this study

Official title: A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age

The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.

Conditions: Herpes Zoster
Being tested: Zoster Vaccine, Live, Comparator: placebo
Medical subject headings: Herpes Zoster

What participants receive

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

Zoster Vaccine, LiveBiological
single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.
Comparator: placeboBiological
single 0.65 mL Placebo injection. 6 month treatment period.

Study groups in NCT00550745
Study group	Role	What they receive
1	Experimental	Arm 1: vaccine Receives: Biological: Zoster Vaccine, Live
2	Placebo comparator	Arm 2: Placebo Comparator Receives: Biological: Comparator: placebo

What is being measured

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

Serious Adverse Events Reported Within 42 Days Postvaccination
Only Serious Adverse Events were collected and analyzed for this
study.
A serious adverse event 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.
Measured: 42 Days

Secondary outcomes (1)

Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
Only Serious Adverse Events were collected and analyzed for this study.
A serious adverse event 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.
Measured: 6 months

Timeline

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

Sep 2007Jan 2009

First posted30 Oct 2007 (estimated)
Study startSep 2007
Primary completionJan 2009
Study completionJan 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 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 11,999 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00550745
Sponsor's protocol ID: V211-020
Other IDs: 2007_606
Status last verified: Mar 2017
First submitted: 29 Oct 2007
Last updated: 12 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Murray AV, Reisinger KS, Kerzner B, Stek JE, Sausser TA, Xu J, Wang WW, Chan IS, Annunziato PW, Parrino J. Safety and tolerability of zoster vaccine in adults >/=60 years old. Hum Vaccin. 2011 Nov;7(11):1130-6. doi: 10.4161/hv.7.11.17982. Epub 2011 Nov 1.
PubMed 22048110

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?

Official record

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
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 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age
ClinicalTrials.gov ID: NCT00550745
Acronym / sponsor ID: V211-020
Conditions: Herpes Zoster
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 11,999 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 30 Oct 2007 (estimated)
Results: Posted 2 Feb 2010

Clinical summary

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

The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: Zoster Vaccine, LiveArm 1: vaccine
2	Placebo comparator	Biological: Comparator: placeboArm 2: Placebo Comparator

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

60+ years of Age
Signed an informed consent prior to the start of study
Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination
Females must be postmenopausal or have a negative pregnancy test

Key exclusion criteria (10 listed)

A history of allergic reaction to any vaccine component (including gelatin or neomycin)
Prior receipt of any varicella or zoster vaccine
Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination
Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination
Subject is pregnant or breastfeeding

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
Zoster Vaccine, Livesingle 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.	Biological	1
Comparator: placebosingle 0.65 mL Placebo injection. 6 month treatment period.	Biological	2

Primary outcome

Serious Adverse Events Reported Within 42 Days Postvaccination
Time frame: 42 Days
Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event 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.

1 secondary outcome

Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
Time frame: 6 months

Results and safety

Results posted to the registry on 2 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ZOSTAVAX™	6,000	5,913
Placebo	5,999	5,939

Primary outcome: Serious Adverse Events Reported Within 42 Days Postvaccination

Time frame: 42 Days. Number. Unit: Participants

Measure	ZOSTAVAX™ n = 5979	Placebo n = 5990
Serious Adverse Events (AEs)	84	67
Serious AEs deemed vaccine-related by investigator	2	0
Death	6	5

ZOSTAVAX™ vs Placebo: Risk Ratio (RR): 1.26 (95% CI 0.91 to 1.73)

Population analysed: All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up. Death - Number of subjects that had a fatal serious adverse event with an onset date within the 42 day reporting period. The date of death may have occurred after 42 days.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk". Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ZOSTAVAX™	340 of 5,979 (5.7%)	0 of 0	Not reported
Placebo	300 of 5,990 (5%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22048110Murray AV, Reisinger KS, Kerzner B, Stek JE, Sausser TA, Xu J, Wang WW, Chan IS, Annunziato PW, Parrino J. Safety and tolerability of zoster vaccine in adults >/=60 years old. Hum Vaccin. 2011 Nov;7(11):1130-6. doi: 10.4161/hv.7.11.17982. Epub 2011 Nov 1.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Herpes Zoster

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
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

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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zoster Vaccine, Live in people with 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 4 inclusion and 10 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 12 Apr 2017. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 2 Feb 2010). 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?

Serious Adverse Events Reported Within 42 Days Postvaccination (time frame: 42 Days). 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 NCT00550745, 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 12 Apr 2017.