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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01385566

First received: June 28, 2011

Last updated: February 19, 2013

Last verified: February 2013

History of Changes

Results First Received: December 11, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Prevention
Condition:	Herpes Zoster
Interventions:	Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous Biological: ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal Biological: Full Dose Intradermal Placebo Biological: Intradermal Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.
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.
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.
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.
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.
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.

Participant Flow: Overall Study

	Full Dose Subcutaneous	1/3 Dose Subcutaneous	Full Dose Intradermal	1/3 Dose Intradermal	1/10 Dose Intradermal	1/27 Dose Intradermal
STARTED	52	34	34	35	34	34
COMPLETED	51	34	34	34	34	34
NOT COMPLETED	1	0	0	1	0	0
Lost to Follow-up	1	0	0	0	0	0
Withdrawal by Subject	0	0	0	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
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.
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.
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.
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.
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.
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.
Total	Total of all reporting groups

Baseline Measures

	Full Dose Subcutaneous	1/3 Dose Subcutaneous	Full Dose Intradermal	1/3 Dose Intradermal	1/10 Dose Intradermal	1/27 Dose Intradermal	Total
Number of Participants [units: participants]	52	34	34	35	34	34	223
Age [units: years] Mean ± Standard Deviation	59.9 ± 7.7	60.5 ± 7.5	62.1 ± 8.5	61.2 ± 8.7	61.6 ± 8.1	60.1 ± 7.1	60.8 ± 7.9
Gender [units: participants]
Female	31	20	17	17	16	24	125
Male	21	14	17	18	18	10	98

Outcome Measures

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1. Primary:

Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies [ Time Frame: Baseline and 6 weeks following vaccine administration ]

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2. Primary:

Number of Participants Reporting an Adverse Experience (AE) [ Time Frame: Up to 42 days following vaccine administration ]

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3. Primary:

Number of Participants Reporting a Serious Adverse Experience (SAE) [ Time Frame: Up to 42 days following vaccine administration ]

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4. Primary:

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 ]

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5. Primary:

Number of Participants Reporting Systemic Adverse Experiences [ Time Frame: Up to 42 days following vaccine administration ]

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6. Primary:

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 ]

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7. Primary:

Number of Participants Reporting a Serious Adverse Experience [ Time Frame: Within 5 days after the blood draw at approximately 20 months following vaccine administration ]

Results not yet posted. Anticipated Posting Date: 07/2014 Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication or presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01385566 History of Changes
Other Study ID Numbers:	V211-051
Study First Received:	June 28, 2011
Results First Received:	December 11, 2012
Last Updated:	February 19, 2013
Health Authority:	United States: Food and Drug Administration

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