Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
NCT ID: NCT00574795
Last Updated: 2012-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
193 participants
INTERVENTIONAL
2007-09-30
2008-08-31
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
SINGLE_GROUP
PREVENTION
NONE
Interventions
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13vPnC
"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"
Eligibility Criteria
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Inclusion Criteria
* Available for entire study period
Exclusion Criteria
* Previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with a pneumococcal conjugate vaccine.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
* Known or suspected immune deficiency or suppression.
2 Months
6 Months
ALL
Yes
Sponsors
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Wyeth is now a wholly owned subsidiary of 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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Nagoya, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Chiba, Chiba, Japan
Matsuyama, Ehime, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Maebaru-shi, Fukuoka, Japan
Asahikawa-shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Yokohama, Kanagawa, Japan
Yokosuka-shi, Kanagawa, Japan
Nangoku-shi, Kochi, Japan
Ise-shi, Mie-ken, Japan
Tsu, Mie-ken, Japan
Yokkaichi-shi, Mie-ken, Japan
Kurashiki-shi, Okayama-ken, Japan
Meguro-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Countries
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References
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Togashi T, Yamaji M, Thompson A, Giardina PC, Aizawa M, Patterson S, Gruber WC, Scott DA; 3003 Study Group. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants in Japan. Pediatr Infect Dis J. 2013 Sep;32(9):984-9. doi: 10.1097/INF.0b013e318293007e.
Other Identifiers
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6096A1-3003
Identifier Type: -
Identifier Source: org_study_id