Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults

NCT ID: NCT00744263

Last Updated: 2014-10-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84496 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate vaccine in the prevention of the first episode of vaccine-type pneumococcal community-acquired pneumonia in adults.

Detailed Description

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Conditions

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Pneumonia, Pneumococcal Pneumococcal Infections 13-valent Pneumococcal Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

VACCINE: placebo

Intervention Type BIOLOGICAL

0.5 mL, single intra-muscular injection

13-valent pneumococcal conjugate vaccine

Group Type EXPERIMENTAL

VACCINE: 13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

0.5 mL, single intra-muscular injection

Interventions

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VACCINE: placebo

0.5 mL, single intra-muscular injection

Intervention Type BIOLOGICAL

VACCINE: 13-valent pneumococcal conjugate vaccine

0.5 mL, single intra-muscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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13vPnC

Eligibility Criteria

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Inclusion Criteria

* Male or female adults aged 65 years or older on the day of vaccination and able to fulfill study requirements.

Exclusion Criteria

* Previous vaccination with any licensed or experimental pneumococcal vaccine
* Residence in a nursing home, long-term care facility, or similar facility
* Known hypersensitivity to vaccination
* Immune deficiency or suppression
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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Countries

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Netherlands

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.

Reference Type DERIVED
PMID: 29429807 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29017280 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28410813 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28173960 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25785969 (View on PubMed)

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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