ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00535730

First received: September 21, 2007

Last updated: March 1, 2013

Last verified: March 2013

History of Changes

Results First Received: January 21, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Conditions:	Herpes Zoster Pneumococcal Infection
Interventions:	Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™ Biological: Comparator: placebo (concomitant-vaccine matched) Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23

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
Phase III First subject enrolled on 18-Jun-2007. Last subject enrolled on 05-Dec-2007. The last subject's last visit was 11-Feb-2008. The study was conducted at 18 study centers throughout Canada, Australia, and Europe.

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

Phase III

First subject enrolled on 18-Jun-2007.

Last subject enrolled on 05-Dec-2007.

The last subject's last visit was 11-Feb-2008.

The study was conducted at 18 study centers throughout Canada, Australia, and Europe.

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
Nonconcomitant Group	Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
Concomitant Group	Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1

Participant Flow: Overall Study

	Nonconcomitant Group	Concomitant Group
STARTED	236	237 ^[1]
COMPLETED	234	230
NOT COMPLETED	2	7
Adverse Event	1	1
Lost to Follow-up	0	1
Physician Decision	0	1
Protocol Violation	1	0
Withdrawal by Subject	0	4

[1]	Two subjects were allocated but not vaccinated making the number of subjects vaccinated 235

Baseline Characteristics

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Reporting Groups

	Description
Nonconcomitant Group	Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
Concomitant Group	Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
Total	Total of all reporting groups

Baseline Measures

	Nonconcomitant Group	Concomitant Group	Total
Number of Participants [units: participants]	236	235	471
Age [units: years] Mean ± Standard Deviation	66.0 ± 5.6	66.3 ± 5.6	66.2 ± 5.6
Gender [units: participants]
Female	135	138	273
Male	101	97	198
Race/Ethnicity, Customized [units: participants]
Asian	1	1	2
Black or African American	0	1	1
White	235	233	468

Outcome Measures

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1. Primary:

Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination [ Time Frame: 4 weeks postvaccination ]

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2. Primary:

Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination. [ Time Frame: Four weeks postvaccination ]

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3. Primary:

Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination. [ Time Frame: Four weeks postvaccination ]

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4. Primary:

Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination. [ Time Frame: Four weeks postvaccination ]

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5. Primary:

Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination. [ Time Frame: Four weeks postvaccination ]

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6. Primary:

Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination. [ Time Frame: Four weeks postvaccination ]

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7. Secondary:

Safety and Tolerability of Both Vaccines When Administered Concomitantly. [ Time Frame: Eight weeks postvaccination ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Nonconcomitant Group	Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
Concomitant Group	Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1

Serious Adverse Events

	Nonconcomitant Group	Concomitant Group
Total, serious adverse events
# participants affected	4	2
Ear and labyrinth disorders
Vertigo ^{* 1}
# participants affected / at risk	0/236 (0.00%)	1/235 (0.43%)
Infections and infestations
Diverticulitis ^{* 1}
# participants affected / at risk	1/236 (0.42%)	0/235 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma ^{* 1}
# participants affected / at risk	1/236 (0.42%)	0/235 (0.00%)
Nervous system disorders
Global amnesia ^{* 1}
# participants affected / at risk	1/236 (0.42%)	0/235 (0.00%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease ^{* 1}
# participants affected / at risk	1/236 (0.42%)	0/235 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis contact ^{* 1}
# participants affected / at risk	0/236 (0.00%)	1/235 (0.43%)
Vascular disorders
Haematoma ^{* 1}
# participants affected / at risk	1/236 (0.42%)	0/235 (0.00%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 11.0

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: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00535730 History of Changes
Other Study ID Numbers:	2007_592, V211-012
Study First Received:	September 21, 2007
Results First Received:	January 21, 2009
Last Updated:	March 1, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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