13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India
NCT ID: NCT02034877
Last Updated: 2016-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1200 participants
INTERVENTIONAL
2014-08-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PREVENTION
NONE
Study Groups
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1
13-valent Pneumococcal conjugate vaccine
1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1
Blood sample collection
10 mL of blood will be collected just before and approximately 1 month after vaccination.
Interventions
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13-valent Pneumococcal conjugate vaccine
1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1
Blood sample collection
10 mL of blood will be collected just before and approximately 1 month after vaccination.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
65 Years
ALL
Yes
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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King George Hospital
Visakhapatnam, Andhra Pradesh, India
B. J. Medical College & Civil Hospital
Ahmedabad, Gujarat, India
S.B.K.S Medical Institute & Research Centre
Vadodara, Gujarat, India
M.S. Ramaiah Cliical Research Centre, M.S. Ramaiah Medical College & Hospitals
Bangalore, Karnataka, India
M.S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India
Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd.
Hubli, Karnataka, India
Cheluvamba Hospital
Mysore, Karnataka, India
Niramaya Hospital
Chinchwad Pune, Maharashtra, India
Supe Heart & Diabetes Hospital and Research Centre
Nashik, Maharashtra, India
Chopda Medicare and Research Centre Pvt. Ltd
Nashik, Maharashtra, India
Medipoint Hospitals Pvt. Ltd.
Pune, Maharashtra, India
Padmashree Dr. D. Y. Patil Medical College
Pune, Maharashtra, India
Christian Medical College
Vellore, Tamil Nadu, India
Samvedna Hospital
Varanasi, Uttar Pradesh, India
Bhatia Hospital
Mumbai, , India
Orange City Hospital and Research Institute
Nagpur, , India
Countries
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References
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Solanki BB, Juergens C, Chopada MB, Supe P, Sundaraiyer V, Le Dren-Narayanin N, Cutler MW, Gruber WC, Scott DA, Schmoele-Thoma B. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial. Hum Vaccin Immunother. 2017 Sep 2;13(9):2065-2071. doi: 10.1080/21645515.2017.1331796.
Agarkhedkar S, Juergens C, Balasundaram K, Agarkhedkar S, Sundaraiyer V, Le Dren-Narayanin N, Cutler MW, Gruber WC, Scott DA, Schmoele-Thoma B; B1851140 Study Team. Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Children 6-17 Years of Age in India: An Open-label Trial. Pediatr Infect Dis J. 2017 Nov;36(11):e283-e285. doi: 10.1097/INF.0000000000001695.
Related Links
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Other Identifiers
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2014-001174-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1851140
Identifier Type: -
Identifier Source: org_study_id
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