Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
NCT ID: NCT01200368
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
551 participants
INTERVENTIONAL
2010-09-24
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
Experimental
13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL per dose, 4 doses
diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
0.5 mL per dose, 4 doses
2
Active comparator
7-valent pneumococcal conjugate vaccine (7vPnC)
0.5 mL per dose, 4 doses
DTaP
0.5 mL per dose, 4 doses
3
Active comparator
DTaP
0.5 mL per dose, 4 doses
Interventions
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13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL per dose, 4 doses
diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
0.5 mL per dose, 4 doses
7-valent pneumococcal conjugate vaccine (7vPnC)
0.5 mL per dose, 4 doses
DTaP
0.5 mL per dose, 4 doses
DTaP
0.5 mL per dose, 4 doses
Eligibility Criteria
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Inclusion Criteria
* Available for the entire study period and whose parent/legal guardian can be reached by telephone.
* Healthy infant as determined by medical history, physical examination, and judgement of the investigator.
Exclusion Criteria
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
* History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
* Infant who is a direct descendant (child, grandchild) of the study site personnel.
3 Months
6 Months
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Sunrise Children's Clinic
Funabashi, Chiba, Japan
Sotobo Children's Clinic
Isumi, Chiba, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
Fukazawa Pediatric Clinic
Higashi-ku, Fukuoka-city, Fukuoka, Japan
National Hospital Organization Fukuyama Medical Center
Fukuyama, Hiroshima, Japan
National Hospital Organization Kure Medical Center
Kure, Hiroshima, Japan
Nakata pediatric clinic
Sapporo, Hokkaido, Japan
Watanabe Pediatric Allergy Clinic
Sapporo, Hokkaido, Japan
Furuta Children's Clinic
Sapporo, Hokkaido, Japan
Motomachi pediatric clinic
Sapporo, Hokkaido, Japan
Tenshi Hospital
Sapporo, Hokkaido, Japan
Yoshimoto Pediatrist Clinic
Kikuchi-gun, Kumamoto, Japan
Shiroko Clinic
Suzuka, Mie-ken, Japan
National Mie Hospital
Tsu, Mie-ken, Japan
National hospital Organization Mie Chuou Medical Center
Tsu, Mie-ken, Japan
Children's Enomoto Clinic
Kumagaya, Saitama, Japan
Shibuya Clinic
Kumagaya, Saitama, Japan
Sakiyama Children's Clinic
Fuchū, Tokyo, Japan
Okawa Children and Family Clinic
Ōta-ku, Tokyo, Japan
Seijo Sasamoto Pediatric And Allergy Clinic
Setagaya-ku, Tokyo, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan
Miyata Pediatric Clinic
Tachikawa-shi, Tokyo, Japan
Maehara Pediatric Clinic
Tama, Tokyo, Japan
Childrens Clinic of Kose
Kofu, Yamanashi, Japan
Medical Corporation Bunpoukai Amemiya Clinic
Koushu-shi, Yamanashi, Japan
Medical Corporation Seijinkai Takei Clinic
Tsuru-shi, Yamanashi, Japan
National Hospital Organization Fukuoka National Hospital
Fukuoka, , Japan
Harada Clinic
Fukuoka, , Japan
Hattori Pediatric Clinic
Kumamoto, , Japan
Medical Corporation Seiaikai Seguchi Pediatric Clinic
Kumamoto, , Japan
Medical Corporation Oukakai Sakuranbo Kodomo Clinic
Kumamoto, , Japan
Momotaro Clinic
Okayama, , Japan
Countries
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References
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Togashi T, Okada K, Yamaji M, Thompson A, Gurtman A, Cutler M, Aizawa M, Gruber WC, Scott DA. Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine Given With DTaP Vaccine in Healthy Infants in Japan. Pediatr Infect Dis J. 2015 Oct;34(10):1096-104. doi: 10.1097/INF.0000000000000819.
Other Identifiers
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B1851056
Identifier Type: -
Identifier Source: secondary_id
6096A1-3024
Identifier Type: OTHER
Identifier Source: secondary_id
B1851056
Identifier Type: -
Identifier Source: org_study_id