Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
NCT ID: NCT00744263
Last Updated: 2014-10-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
84496 participants
INTERVENTIONAL
2008-09-30
2013-10-31
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
QUADRUPLE
Study Groups
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Placebo
VACCINE: placebo
0.5 mL, single intra-muscular injection
13-valent pneumococcal conjugate vaccine
VACCINE: 13-valent pneumococcal conjugate vaccine
0.5 mL, single intra-muscular injection
Interventions
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VACCINE: placebo
0.5 mL, single intra-muscular injection
VACCINE: 13-valent pneumococcal conjugate vaccine
0.5 mL, single intra-muscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Residence in a nursing home, long-term care facility, or similar facility
* Known hypersensitivity to vaccination
* Immune deficiency or suppression
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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Pfizer Investigational Site
Tilburg, North Brabant, Netherlands
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Abbekerk, , Netherlands
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Alkmaar, , Netherlands
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Alkmaar, , Netherlands
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Almelo, , Netherlands
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Almere Stad, , Netherlands
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Almere Stad, , Netherlands
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Alphen aan den Rijn, , Netherlands
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Amersfoort, , Netherlands
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Amersfoort, , Netherlands
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Amstelveen, , Netherlands
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Amstelveen, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Apeldoorn, , Netherlands
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Apeldoorn, , Netherlands
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Apeldoorn, , Netherlands
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Arnhem, , Netherlands
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Arnhem, , Netherlands
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Assen, , Netherlands
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Assen, , Netherlands
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Baarle-Nassau, , Netherlands
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Baarn, , Netherlands
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Bedum, , Netherlands
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Bennebroek, , Netherlands
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Bergen op Zoom, , Netherlands
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Bergen op Zoom, , Netherlands
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Berkel-Enschot, , Netherlands
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Berkhout, , Netherlands
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Bilthoven, , Netherlands
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Blaricum, , Netherlands
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Breda, , Netherlands
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Breda, , Netherlands
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Breda, , Netherlands
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Brunssum, , Netherlands
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Deventer, , Netherlands
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Deventer, , Netherlands
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Dongen, , Netherlands
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Eelde, , Netherlands
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Eindhoven, , Netherlands
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Eindhoven, , Netherlands
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Eindhoven, , Netherlands
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Eindhoven, , Netherlands
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Eindhoven, , Netherlands
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Emmen, , Netherlands
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Emmen, , Netherlands
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Enschede, , Netherlands
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Enschede, , Netherlands
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Epe, , Netherlands
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Ettenleur, , Netherlands
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Fijnaart, , Netherlands
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Geldrop, , Netherlands
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Geldrop, , Netherlands
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Geldrop, , Netherlands
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Goirle, , Netherlands
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Gouda, , Netherlands
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Gouda, , Netherlands
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Groningen, , Netherlands
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Groningen, , Netherlands
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Groningen, , Netherlands
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Groningen, , Netherlands
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Grootebroek, , Netherlands
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Haarlem, , Netherlands
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Haarlem, , Netherlands
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Haren, , Netherlands
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Harmelen, , Netherlands
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Heerhugowaard, , Netherlands
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Heerlen, , Netherlands
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Heerlen, , Netherlands
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Heiloo, , Netherlands
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Helmond, , Netherlands
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Hengelo, , Netherlands
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Hengelo, , Netherlands
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Hilvarenbeek, , Netherlands
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Hilversum, , Netherlands
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Hilversum, , Netherlands
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Hoofddorp, , Netherlands
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Hoogezand, , Netherlands
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Hoorn, , Netherlands
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Hoorn, , Netherlands
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Hoorn, , Netherlands
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Houten, , Netherlands
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Kampen, , Netherlands
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Katwijk, , Netherlands
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Kerkrade, , Netherlands
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Leek, , Netherlands
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Leeuwarden, , Netherlands
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Leeuwarden, , Netherlands
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Leiden, , Netherlands
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Leiden, , Netherlands
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Leiden, , Netherlands
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Leiderdorp, , Netherlands
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Maarssen, , Netherlands
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Maastricht, , Netherlands
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Maastricht, , Netherlands
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Medemblik, , Netherlands
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Nieuwegein, , Netherlands
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Nieuwegein, , Netherlands
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Nijmegen, , Netherlands
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Nijmegen, , Netherlands
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Nijmegen, , Netherlands
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Noordwijk, , Netherlands
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Oldenzaal, , Netherlands
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Oosterhout, , Netherlands
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Peize, , Netherlands
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Rheden, , Netherlands
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Riel, , Netherlands
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Rijsbergen, , Netherlands
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Rijssen, , Netherlands
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Roden, , Netherlands
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Roermond, , Netherlands
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Roermond, , Netherlands
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Roermond, , Netherlands
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Roosendaal, , Netherlands
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Roosendaal, , Netherlands
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Schoorl, , Netherlands
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Simpelveld, , Netherlands
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Sittard, , Netherlands
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Sittard, , Netherlands
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Sleen, , Netherlands
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Soest, , Netherlands
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Son, , Netherlands
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Spaubeek, , Netherlands
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Steenbergen, , Netherlands
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Tiel, , Netherlands
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Tilburg, , Netherlands
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Tilburg, , Netherlands
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Tilburg, , Netherlands
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Uithoorn, , Netherlands
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Urmond, , Netherlands
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Utrecht, , Netherlands
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Utrecht, , Netherlands
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Utrecht, , Netherlands
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Utrecht, , Netherlands
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Utrecht, , Netherlands
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Utrecht, , Netherlands
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Veldhoven, , Netherlands
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Veldhoven, , Netherlands
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Veldhoven, , Netherlands
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Velp, , Netherlands
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Venlo, , Netherlands
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Venlo, , Netherlands
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Waalwijk, , Netherlands
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Warmenhuizen, , Netherlands
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Weert, , Netherlands
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Woerden, , Netherlands
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Zeist, , Netherlands
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Zeist, , Netherlands
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Zeist, , Netherlands
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Zevenaar, , Netherlands
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Zutphen, , Netherlands
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Zutphen, , Netherlands
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Zwolle, , Netherlands
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Zwolle, , Netherlands
Countries
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References
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Suaya JA, Jiang Q, Scott DA, Gruber WC, Webber C, Schmoele-Thoma B, Hall-Murray CK, Jodar L, Isturiz RE. Post hoc analysis of the efficacy of the 13-valent pneumococcal conjugate vaccine against vaccine-type community-acquired pneumonia in at-risk older adults. Vaccine. 2018 Mar 7;36(11):1477-1483. doi: 10.1016/j.vaccine.2018.01.049. Epub 2018 Feb 9.
van Deursen AMM, van Houten MA, Webber C, Patton M, Scott DA, Patterson S, Sidhu M, Drews W, Gruber WC, Emini EA, Grobbee DE, Bonten MJM, Sanders EAM. Immunogenicity of the 13-Valent Pneumococcal Conjugate Vaccine in Older Adults With and Without Comorbidities in the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA). Clin Infect Dis. 2017 Sep 1;65(5):787-795. doi: 10.1093/cid/cix419.
Huijts SM, van Werkhoven CH, Bolkenbaas M, Grobbee DE, Bonten MJM. Post-hoc analysis of a randomized controlled trial: Diabetes mellitus modifies the efficacy of the 13-valent pneumococcal conjugate vaccine in elderly. Vaccine. 2017 Aug 3;35(34):4444-4449. doi: 10.1016/j.vaccine.2017.01.071. Epub 2017 Apr 12.
Webber C, Patton M, Patterson S, Schmoele-Thoma B, Huijts SM, Bonten MJ; CAPiTA Study Group. Exploratory efficacy endpoints in the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA). Vaccine. 2017 Mar 1;35(9):1266-1272. doi: 10.1016/j.vaccine.2017.01.032. Epub 2017 Feb 4.
Bonten MJ, Huijts SM, Bolkenbaas M, Webber C, Patterson S, Gault S, van Werkhoven CH, van Deursen AM, Sanders EA, Verheij TJ, Patton M, McDonough A, Moradoghli-Haftvani A, Smith H, Mellelieu T, Pride MW, Crowther G, Schmoele-Thoma B, Scott DA, Jansen KU, Lobatto R, Oosterman B, Visser N, Caspers E, Smorenburg A, Emini EA, Gruber WC, Grobbee DE. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015 Mar 19;372(12):1114-25. doi: 10.1056/NEJMoa1408544.
Related Links
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Other Identifiers
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B1851025
Identifier Type: -
Identifier Source: secondary_id
6115A1-3006
Identifier Type: -
Identifier Source: org_study_id
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