A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
NCT ID: NCT01385566
Last Updated: 2016-06-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
223 participants
INTERVENTIONAL
2011-09-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Full Dose Subcutaneous
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.
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous
One 0.65 mL injection subcutaneously on Day 1
Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
1/3 Dose Subcutaneous
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.
ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous
One approximately 0.22 mL injection subcutaneously on Day 1
Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
Full Dose Intradermal
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.
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal
Two intradermal injections of approximately 0.15 mL each on Day 1
Full Dose Intradermal Placebo
Two intradermal placebo injections of approximately 0.15 mL each on Day 1
1/3 Dose Intradermal
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.
ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
One intradermal injection of approximately 0.1 mL on Day 1
Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
1/10 Dose Intradermal
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.
ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
One intradermal injection of approximately 0.1 mL on Day 1
Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
1/27 Dose Intradermal
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.
ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
One intradermal injection of approximately 0.1 mL on Day 1
Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
Interventions
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ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous
One 0.65 mL injection subcutaneously on Day 1
ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous
One approximately 0.22 mL injection subcutaneously on Day 1
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal
Two intradermal injections of approximately 0.15 mL each on Day 1
ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
One intradermal injection of approximately 0.1 mL on Day 1
Full Dose Intradermal Placebo
Two intradermal placebo injections of approximately 0.15 mL each on Day 1
Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
50 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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References
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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.
Other Identifiers
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V211-051
Identifier Type: -
Identifier Source: org_study_id
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