Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years
NCT ID: NCT00562354
Last Updated: 2011-11-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
271 participants
INTERVENTIONAL
2007-10-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Stratum 1: \>= 65 years of age
13vPnC
13vPnC for both stratum
2
Stratum 2: 50 to 64 years of age
13vPnC
13vPnC for both stratum
Interventions
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13vPnC
13vPnC for both stratum
Eligibility Criteria
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Inclusion Criteria
* Determined to be eligible for the study based on medical history, physical examination, and clinical judgment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of study vaccine, are eligible.
* Sexually active men must agree and commit to use a medically accepted form of contraception during the study and for at least 3 months after vaccination.
Exclusion Criteria
* Receipt of any vaccine within 30 days before study vaccination, except influenza vaccine.
* Documented S pneumoniae infection within the past 5 years before study vaccination.
50 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Fukuoka, Fukuoka, Japan
Sumida-ku, Tokyo, Japan
Countries
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References
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Shiramoto M, Irie S, Juergens C, Yamaji M, Tamai S, Aizawa M, Belanger T, Gruber WC, Scott DA, Schmoele-Thoma B. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine when administered to healthy Japanese adults aged >/=50 years. An open-label trial. Hum Vaccin Immunother. 2014;10(7):1850-8. doi: 10.4161/hv.28633.
Other Identifiers
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6115A1-3004
Identifier Type: -
Identifier Source: org_study_id