ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)
NCT ID: NCT00535730
Last Updated: 2017-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
473 participants
INTERVENTIONAL
2007-06-30
2008-02-29
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
DOUBLE
Study Groups
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1
Placebo Comparator
Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™
0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period
Comparator: placebo (concomitant-vaccine matched)
Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.
2
vaccine
Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™
0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period
Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23
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
Comparator: placebo (concomitant-vaccine matched)
Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.
Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23
Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable underlying conditions
* Postmenopausal if female
* Afebrile
Exclusion Criteria
* Immune deficiency
* History of allergy to components in either vaccine
* Concomitant antiviral therapy
60 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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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.
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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