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

NCT ID: NCT00535730

Last Updated: 2017-04-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

473 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-02-29

Brief Summary

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The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given together (in different body sites), as when they are given alone, in adults 60 years of age and older.

Detailed Description

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Conditions

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Herpes Zoster Pneumococcal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Placebo Comparator

Group Type PLACEBO_COMPARATOR

Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™

Intervention Type BIOLOGICAL

0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period

Comparator: placebo (concomitant-vaccine matched)

Intervention Type BIOLOGICAL

Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.

2

vaccine

Group Type EXPERIMENTAL

Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™

Intervention Type BIOLOGICAL

0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period

Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23

Intervention Type BIOLOGICAL

Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.

Interventions

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Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™

0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period

Intervention Type BIOLOGICAL

Comparator: placebo (concomitant-vaccine matched)

Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.

Intervention Type BIOLOGICAL

Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23

Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.

Intervention Type BIOLOGICAL

Other Intervention Names

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ZOSTAVAX™ PNEUMOVAX™ 23

Eligibility Criteria

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Inclusion Criteria

* 60 years of age or older
* Stable underlying conditions
* Postmenopausal if female
* Afebrile

Exclusion Criteria

* Previously vaccinated with either vaccine
* Immune deficiency
* History of allergy to components in either vaccine
* Concomitant antiviral therapy
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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MacIntyre CR, Egerton T, McCaughey M, Parrino J, Campbell BV, Su SC, Pagnoni MF, Stek JE, Xu J, Annunziato PW, Chan IS, Silber JL. Concomitant administration of zoster and pneumococcal vaccines in adults >/=60 years old. Hum Vaccin. 2010 Nov;6(11):894-902. doi: 10.4161/hv.6.11.12852. Epub 2010 Nov 1.

Reference Type RESULT
PMID: 20980796 (View on PubMed)

Other Identifiers

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2007_592

Identifier Type: -

Identifier Source: secondary_id

V211-012

Identifier Type: -

Identifier Source: org_study_id

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