Herpes ZosterPhase 1NCT01385566

A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)

A Phase 1 study testing ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous, ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous and ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal 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.

Official record

Search all trials

Trial summary

This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses. 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?: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous, ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous and ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 223 participants
Where: No sites listed yet
Study dates: Sep 2011to May 2013
Phase: Phase 1
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

Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years
Temperature less than 100.4 °F on day of vaccination
Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination
In good health

Who cannot join

History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin
Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals
Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella
Prior history of herpes zoster
Prior receipt of any varicella or zoster vaccine
Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination

Show all 14Show fewer

On immunosuppressive therapy
Known or suspected immune dysfunction
Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits
Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine
Not ambulatory
Pregnant or breastfeeding
Use of nontopical antiviral therapy with activity against herpes viruses
Active untreated tuberculosis

About this study

Official title: A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)

This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.

Read the detailed description

This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.

Conditions: Herpes Zoster
Being tested: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous, ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous, ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal, ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal, Full Dose Intradermal 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.

ZOSTAVAX™ (Zoster Vaccine Live) Full Dose SubcutaneousBiological
Also called V211
One 0.65 mL injection subcutaneously on Day 1
ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose SubcutaneousBiological
Also called V211
One approximately 0.22 mL injection subcutaneously on Day 1
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose IntradermalBiological
Also called V211
Two intradermal injections of approximately 0.15 mL each on Day 1
ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses IntradermalBiological
Also called V211
One intradermal injection of approximately 0.1 mL on Day 1
Full Dose Intradermal PlaceboBiological
Two intradermal placebo injections of approximately 0.15 mL each on Day 1
Intradermal PlaceboBiological
One intradermal placebo injection of approximately 0.1 mL on Day 1

Study groups in NCT01385566
Study group	Role	What they receive
Full Dose Subcutaneous	Active comparator	Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Receives: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous; Biological: Intradermal Placebo
1/3 Dose Subcutaneous	Experimental	Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. Receives: Biological: ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous; Biological: Intradermal Placebo
Full Dose Intradermal	Experimental	Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. Receives: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal; Biological: Full Dose Intradermal Placebo
1/3 Dose Intradermal	Experimental	Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. Receives: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal; Biological: Intradermal Placebo
1/10 Dose Intradermal	Experimental	Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. Receives: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal; Biological: Intradermal Placebo
1/27 Dose Intradermal	Experimental	Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. Receives: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal; Biological: Intradermal Placebo

What is being measured

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

Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies
VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.
Measured: Baseline and 6 weeks following vaccine administration
Number of Participants Reporting an Adverse Experience (AE)
An AE is defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Measured: Up to 42 days following vaccine administration
Number of Participants Reporting a Serious Adverse Experience (SAE)
An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.
Measured: Up to 42 days following vaccine administration
Number of Participants Reporting a Serious Adverse Experience
An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention
Measured: Within 5 days after the blood draw at approximately 20 months following vaccine administration
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.
Measured: Up to 5 days following vaccine administration
Number of Participants Reporting Systemic Adverse Experiences
Systemic AEs included all reported AEs except injection-site AEs
Measured: Up to 42 days following vaccine administration
Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)
Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.
Measured: Up to 42 days following vaccine administration

Timeline

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

Sep 2011May 2013

First posted30 Jun 2011 (estimated)
Study startSep 2011
Primary completionMay 2013
Study completionMay 2013

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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01385566
Sponsor's protocol ID: V211-051
Status last verified: May 2016
First submitted: 28 Jun 2011
Last updated: 23 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Beals CR, Railkar RA, Schaeffer AK, Levin Y, Kochba E, Meyer BK, Evans RK, Sheldon EA, Lasseter K, Lang N, Weinberg A, Canniff J, Levin MJ. Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial. Lancet Infect Dis. 2016 Aug;16(8):915-22. doi: 10.1016/S1473-3099(16)00133-X. Epub 2016 Apr 6.
PubMed 27061887

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 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)
ClinicalTrials.gov ID: NCT01385566
Acronym / sponsor ID: V211-051
Conditions: Herpes Zoster
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 223 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 30 Jun 2011 (estimated)
Results: Posted 21 Feb 2013

Clinical summary

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

This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Full Dose Subcutaneous	Active comparator	Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous, Biological: Intradermal PlaceboParticipants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous	Experimental	Biological: ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous, Biological: Intradermal PlaceboParticipants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal	Experimental	Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal, Biological: Full Dose Intradermal PlaceboParticipants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal	Experimental	Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal, Biological: Intradermal PlaceboParticipants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal	Experimental	Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal, Biological: Intradermal PlaceboParticipants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal	Experimental	Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal, Biological: Intradermal PlaceboParticipants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

Who may qualify

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

Key inclusion criteria (4 listed)

Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years
Temperature less than 100.4 °F on day of vaccination
Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination
In good health

Key exclusion criteria (14 listed)

History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin
Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals
Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella
Prior history of herpes zoster
Prior receipt of any varicella or zoster 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
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose SubcutaneousAlso: V211One 0.65 mL injection subcutaneously on Day 1	Biological	Full Dose Subcutaneous
ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose SubcutaneousAlso: V211One approximately 0.22 mL injection subcutaneously on Day 1	Biological	1/3 Dose Subcutaneous
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose IntradermalAlso: V211Two intradermal injections of approximately 0.15 mL each on Day 1	Biological	Full Dose Intradermal
ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses IntradermalAlso: V211One intradermal injection of approximately 0.1 mL on Day 1	Biological	1/10 Dose Intradermal, 1/27 Dose Intradermal, 1/3 Dose Intradermal
Full Dose Intradermal PlaceboTwo intradermal placebo injections of approximately 0.15 mL each on Day 1	Biological	Full Dose Intradermal
Intradermal PlaceboOne intradermal placebo injection of approximately 0.1 mL on Day 1	Biological	1/10 Dose Intradermal, 1/27 Dose Intradermal, 1/3 Dose Intradermal, 1/3 Dose Subcutaneous, Full Dose Subcutaneous

Primary outcome

Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies
Time frame: Baseline and 6 weeks following vaccine administration
VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.
Number of Participants Reporting an Adverse Experience (AE)
Time frame: Up to 42 days following vaccine administration
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Number of Participants Reporting a Serious Adverse Experience (SAE)
Time frame: Up to 42 days following vaccine administration
An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.
Number of Participants Reporting a Serious Adverse Experience
Time frame: Within 5 days after the blood draw at approximately 20 months following vaccine administration
An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Time frame: Up to 5 days following vaccine administration
The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.
Number of Participants Reporting Systemic Adverse Experiences
Time frame: Up to 42 days following vaccine administration
Systemic AEs included all reported AEs except injection-site AEs
Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)
Time frame: Up to 42 days following vaccine administration
Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.

Results and safety

Results posted to the registry on 21 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Full Dose Subcutaneous	52	51
1/3 Dose Subcutaneous	34	34
Full Dose Intradermal	34	34
1/3 Dose Intradermal	35	34
1/10 Dose Intradermal	34	34
1/27 Dose Intradermal	34	34

Primary outcome: Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies

Time frame: Baseline and 6 weeks following vaccine administration. Geometric mean (90% Confidence Interval). Unit: Geometric mean fold change

Measure	Full Dose Subcutaneous n = 52	1/3 Dose Subcutaneous n = 34	Full Dose Intradermal n = 34	1/3 Dose Intradermal n = 35	1/10 Dose Intradermal n = 34	1/27 Dose Intradermal n = 34
Value	1.74 (1.48 to 2.05)	1.64 (1.35 to 2.00)	3.24 (2.66 to 3.94)	2.45 (2.02 to 2.97)	2.21 (1.82 to 2.69)	1.64 (1.35 to 2.00)

Population analysed: The population analyzed included participants who received vaccination and did not have any protocol deviations that may have interfered with the immune response.

Primary outcome: Number of Participants Reporting an Adverse Experience (AE)

Time frame: Up to 42 days following vaccine administration. Number. Unit: participants

Measure	Full Dose Subcutaneous n = 52	1/3 Dose Subcutaneous n = 34	Full Dose Intradermal n = 34	1/3 Dose Intradermal n = 35	1/10 Dose Intradermal n = 34	1/27 Dose Intradermal n = 34
Value	30	10	27	23	21	19

Population analysed: The population analyzed was all randomized participants who received study vaccination

Primary outcome: Number of Participants Reporting a Serious Adverse Experience (SAE)

Time frame: Up to 42 days following vaccine administration. Number. Unit: participants

Measure	Full Dose Subcutaneous n = 52	1/3 Dose Subcutaneous n = 34	Full Dose Intradermal n = 34	1/3 Dose Intradermal n = 35	1/10 Dose Intradermal n = 34	1/27 Dose Intradermal n = 34
Value	0	0	0	0	0	0

Population analysed: The population analyzed was all randomized participants who received study vaccination

Primary outcome: Number of Participants Reporting a Serious Adverse Experience

Time frame: Within 5 days after the blood draw at approximately 20 months following vaccine administration. Number. Unit: Participants

Measure	Full Dose Subcutaneous n = 22	1/3 Dose Subcutaneous n = 16	Full Dose Intradermal n = 10	1/3 Dose Intradermal n = 13	1/10 Dose Intradermal n = 15	1/27 Dose Intradermal n = 14
Value	0	0	0	0	0	0

Population analysed: The population analyzed was all randomized participants who received study vaccination and had a Month 20 visit and follow-up

Adverse events

Time frame: Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Full Dose Subcutaneous	0 of 52 (0%)	30 of 52 (57.7%)	Not reported
1/3 Dose Subcutaneous	0 of 34 (0%)	10 of 34 (29.4%)	Not reported
Full Dose Intradermal	0 of 34 (0%)	27 of 34 (79.4%)	Not reported
1/3 Dose Intradermal	0 of 35 (0%)	23 of 35 (65.7%)	Not reported
1/10 Dose Intradermal	0 of 34 (0%)	21 of 34 (61.8%)	Not reported
1/27 Dose Intradermal	0 of 34 (0%)	19 of 34 (55.9%)	Not reported
Placebo	0 of 39 (0%)	5 of 39 (12.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27061887Beals CR, Railkar RA, Schaeffer AK, Levin Y, Kochba E, Meyer BK, Evans RK, Sheldon EA, Lasseter K, Lang N, Weinberg A, Canniff J, Levin MJ. Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial. Lancet Infect Dis. 2016 Aug;16(8):915-22. doi: 10.1016/S1473-3099(16)00133-X. Epub 2016 Apr 6.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 14 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 23 Jun 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 21 Feb 2013). 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 Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies (time frame: Baseline and 6 weeks following vaccine administration). The study lists 7 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 NCT01385566, 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 23 Jun 2016.