ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)

This study has been completed.

Study NCT00546819 Information provided by Merck

First Received on October 17, 2007. Last Updated on July 20, 2011 History of Changes

Results First Received: July 20, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Condition:	Herpes Zoster
Interventions:	Biological: Zoster Vaccine, Live Biological: Comparator: 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
ZOSTAVAX™	Participants administered ZOSTAVAX™ on Day 1.
Placebo	Participants administered Placebo on Day 1.

Participant Flow: Overall Study

	ZOSTAVAX™	Placebo
STARTED	207	102
VACCINATED	206	100
COMPLETED	199	96
NOT COMPLETED	8	6
Adverse Event	2	3
Lost to Follow-up	2	1
Withdrawal by Subject	4	2

Baseline Characteristics

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Reporting Groups

	Description
ZOSTAVAX™	Participants administered ZOSTAVAX™ on Day 1.
Placebo	Participants administered Placebo on Day 1.

Baseline Measures

	ZOSTAVAX™	Placebo	Total
Number of Participants [units: participants]	207	102	309
Age [units: years] Mean ± Standard Deviation	69.8 ± 6.9	69.9 ± 7.2	69.8 ± 7.0
Gender [units: participants]
Female	140	80	220
Male	67	22	89
Daily Corticosteroid Dose Stratum [units: Participants]
5 to 10 mg of prednisone or equivalent	182	88	270
>10 to 20 mg of prednisone or equivalent	25	14	39

Outcome Measures

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1. Primary:

Number of Participants With Serious Adverse Events (SAE) [ Time Frame: Up to 182 days postvaccination ]

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2. Secondary:

Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination [ Time Frame: 42 days postvaccination ]

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3. Secondary:

Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination. [ Time Frame: 42 days postvaccination ]

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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/presentation. SPONSOR review can be expedited to meet publication guidelines.

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
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00546819 History of Changes
Other Study ID Numbers:	V211-017, 2006_557
Study First Received:	October 17, 2007
Results First Received:	July 20, 2011
Last Updated:	July 20, 2011
Health Authority:	United States: Food and Drug Administration