HealthyPhase 3NCT00092417

Evaluation of the Safety and Tolerability of a Higher Potency Dose of an Investigational Vaccine Among Adults 50 Years of Age and Older (V211-009)

A Phase 3 study testing Comparator: Varicella Zoster Virus Vaccine in people with Healthy, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose. Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Comparator: Varicella Zoster Virus Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 695 participants
Where: No sites listed yet
Study dates: Oct 2003to Jun 2004
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

Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster

Who cannot join

Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response

About this study

Official title: Evaluation of the Safety and Tolerability of a Higher Potency Dose of Varicella Zoster Virus Vaccine Live (Oka/Merck)Among Adults 50 Years of Age or Older

This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.

Conditions: Healthy
Being tested: Comparator: Varicella Zoster Virus Vaccine

What participants receive

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

Comparator: Varicella Zoster Virus VaccineBiological
Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (~207,000 plaque-forming units [PFU]/0.65-mL dose)
Comparator: Varicella Zoster Virus VaccineBiological
Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (~58,000 plaque-forming units [PFU]/0.65-mL dose)

Study groups in NCT00092417
Study group	Role	What they receive
1	Experimental	Higher Potency Dose Receives: Biological: Comparator: Varicella Zoster Virus Vaccine
2	Experimental	Lower Potency Dose Receives: Biological: Comparator: Varicella Zoster Virus Vaccine

What is being measured

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

Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)
The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.
Measured: Day 1-42 post vaccination
Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)
Measured: Day 1-5 postvaccination

Timeline

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

Oct 2003Jun 2004

First posted27 Sep 2004 (estimated)
Study startOct 2003
Primary completionJun 2004
Study completionJun 2004

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 HealthyStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 695 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00092417
Sponsor's protocol ID: V211-009
Other IDs: 2004_075
Status last verified: Oct 2015
First submitted: 22 Sep 2004
Last updated: 7 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tyring SK, Diaz-Mitoma F, Padget LG, Nunez M, Poland G, Cassidy WM, Bundick ND, Li J, Chan IS, Stek JE, Annunziato PW; Protocol 009 Study Group. Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age. Vaccine. 2007 Feb 26;25(10):1877-83. doi: 10.1016/j.vaccine.2006.10.027. Epub 2006 Oct 30.
PubMed 17227688

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

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Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Safety and Tolerability of a Higher Potency Dose of Varicella Zoster Virus Vaccine Live (Oka/Merck)Among Adults 50 Years of Age or Older
ClinicalTrials.gov ID: NCT00092417
Acronym / sponsor ID: V211-009
Conditions: Healthy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 695 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2003
Primary completion: Jun 2004 (actual)
Study completion: Jun 2004 (actual)
First posted: 27 Sep 2004 (estimated)
Results: Posted 10 Jun 2010

Clinical summary

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

This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.

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: Comparator: Varicella Zoster Virus VaccineHigher Potency Dose
2	Experimental	Biological: Comparator: Varicella Zoster Virus VaccineLower Potency Dose

Who may qualify

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

Key inclusion criteria (1 listed)

Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster

Key exclusion criteria (1 listed)

Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response

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
Comparator: Varicella Zoster Virus VaccineSingle 0.65 mL subcutaneous injection of higher potency zoster vaccine (~207,000 plaque-forming units [PFU]/0.65-mL dose)	Biological	1
Comparator: Varicella Zoster Virus VaccineSingle 0.65 mL subcutaneous injection of lower potency zoster vaccine (~58,000 plaque-forming units [PFU]/0.65-mL dose)	Biological	2

Primary outcome

Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)
Time frame: Day 1-42 post vaccination
The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.
Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)
Time frame: Day 1-5 postvaccination

Results and safety

Results posted to the registry on 10 Jun 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
Zoster Vaccine Higher Potency	464	459
Zoster Vaccine Lower Potency	234	233

Primary outcome: Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)

Time frame: Day 1-42 post vaccination. Number. Unit: Participants

Measure	Zoster Vaccine Higher Potency n = 459	Zoster Vaccine Lower Potency n = 234
With vaccine-related SAEs	0	0
Without vaccine-related SAEs	459	234

Population analysed: The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.

Primary outcome: Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)

Time frame: Day 1-5 postvaccination. Number. Unit: Participants

Measure	Zoster Vaccine Higher Potency n = 459	Zoster Vaccine Lower Potency n = 234
With moderate or severe injection-site reaction	79	21
Without moderate or severe injection-site reaction	380	213

Population analysed: The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.

Adverse events

Time frame: Day 1 - 42 postvaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zoster Vaccine Higher Potency	4 of 459 (0.9%)	296 of 459 (64.5%)	Not reported
Zoster Vaccine Lower Potency	1 of 234 (0.4%)	141 of 234 (60.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17227688Tyring SK, Diaz-Mitoma F, Padget LG, Nunez M, Poland G, Cassidy WM, Bundick ND, Li J, Chan IS, Stek JE, Annunziato PW; Protocol 009 Study Group. Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age. Vaccine. 2007 Feb 26;25(10):1877-83. doi: 10.1016/j.vaccine.2006.10.027. Epub 2006 Oct 30.

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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Comparator: Varicella Zoster Virus Vaccine in people with Healthy, 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 1 inclusion and 1 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 7 Oct 2015. 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 10 Jun 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?

Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) (time frame: Day 1-42 post vaccination). The study lists 2 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 NCT00092417, 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 7 Oct 2015.