Clinical trial NCT00744263: Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
Official title: A Phase 4, Randomized, Placebo-Controlled Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine Efficacy in Prevention of Vaccine-Serotype Pneumococcal Community-Acquired Pneumonia and Invasive Pneumococcal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia, Pneumococcal
Pneumococcal Infections
13-valent Pneumococcal Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-29
Enrollment: 84496
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)
timeFrame: Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
Secondary outcomes:
measure: Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)
timeFrame: Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
measure: Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases
timeFrame: Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
Other outcomes:
measure: Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
timeFrame: Within 7 days after vaccination
measure: Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
timeFrame: Within 7 days after vaccination
measure: Percentage of Participants Who Died
timeFrame: From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Condition
timeFrame: From 1 month after vaccination up to 6 months after vaccination
Locations:
city: Tilburg
country: Netherlands
facility: Pfizer Investigational Site
state: Noord Brabant
city: Abbekerk
country: Netherlands
facility: Pfizer Investigational Site
city: Alkmaar
country: Netherlands
facility: Pfizer Investigational Site
city: Alkmaar
country: Netherlands
facility: Pfizer Investigational Site
city: Almelo
country: Netherlands
facility: Pfizer Investigational Site
city: Almere
country: Netherlands
facility: Pfizer Investigational Site
city: Almere
country: Netherlands
facility: Pfizer Investigational Site
city: Alphen aan de Rijn
country: Netherlands
facility: Pfizer Investigational Site
city: Amersfoort
country: Netherlands
facility: Pfizer Investigational Site
city: Amersfoort
country: Netherlands
facility: Pfizer Investigational Site
city: Amstelveen
country: Netherlands
facility: Pfizer Investigational Site
city: Amstelveen
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Apeldoorn
country: Netherlands
facility: Pfizer Investigational Site
city: Apeldoorn
country: Netherlands
facility: Pfizer Investigational Site
city: Apeldoorn
country: Netherlands
facility: Pfizer Investigational Site
city: Arnhem
country: Netherlands
facility: Pfizer Investigational Site
city: Arnhem
country: Netherlands
facility: Pfizer Investigational Site
city: Assen
country: Netherlands
facility: Pfizer Investigational Site
city: Assen
country: Netherlands
facility: Pfizer Investigational Site
city: Baarle-Nassau
country: Netherlands
facility: Pfizer Investigational Site
city: Baarn
country: Netherlands
facility: Pfizer Investigational Site
city: Bedum
country: Netherlands
facility: Pfizer Investigational Site
city: Bennebroek
country: Netherlands
facility: Pfizer Investigational Site
city: Bergen op Zoom
country: Netherlands
facility: Pfizer Investigational Site
city: Bergen op Zoom
country: Netherlands
facility: Pfizer Investigational Site
city: Berkel Enschot
country: Netherlands
facility: Pfizer Investigational Site
city: Berkhout
country: Netherlands
facility: Pfizer Investigational Site
city: Bilthoven
country: Netherlands
facility: Pfizer Investigational Site
city: Blaricum
country: Netherlands
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Brunssum
country: Netherlands
facility: Pfizer Investigational Site
city: Deventer
country: Netherlands
facility: Pfizer Investigational Site
city: Deventer
country: Netherlands
facility: Pfizer Investigational Site
city: Dongen
country: Netherlands
facility: Pfizer Investigational Site
city: Eelde
country: Netherlands
facility: Pfizer Investigational Site
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Emmen
country: Netherlands
facility: Pfizer Investigational Site
city: Emmen
country: Netherlands
facility: Pfizer Investigational Site
city: Enschede
country: Netherlands
facility: Pfizer Investigational Site
city: Enschede
country: Netherlands
facility: Pfizer Investigational Site
city: Epe
country: Netherlands
facility: Pfizer Investigational Site
city: Ettenleur
country: Netherlands
facility: Pfizer Investigational Site
city: Fijnaart
country: Netherlands
facility: Pfizer Investigational Site
city: Geldrop
country: Netherlands
facility: Pfizer Investigational Site
city: Geldrop
country: Netherlands
facility: Pfizer Investigational Site
city: Geldrop
country: Netherlands
facility: Pfizer Investigational Site
city: Goirle
country: Netherlands
facility: Pfizer Investigational Site
city: Gouda
country: Netherlands
facility: Pfizer Investigational Site
city: Gouda
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Grootebroek
country: Netherlands
facility: Pfizer Investigational Site
city: Haarlem
country: Netherlands
facility: Pfizer Investigational Site
city: Haarlem
country: Netherlands
facility: Pfizer Investigational Site
city: Haren
country: Netherlands
facility: Pfizer Investigational Site
city: Harmelen
country: Netherlands
facility: Pfizer Investigational Site
city: Heerhugowaard
country: Netherlands
facility: Pfizer Investigational Site
city: Heerlen
country: Netherlands
facility: Pfizer Investigational Site
city: Heerlen
country: Netherlands
facility: Pfizer Investigational Site
city: Heiloo
country: Netherlands
facility: Pfizer Investigational Site
city: Helmond
country: Netherlands
facility: Pfizer Investigational Site
city: Hengelo
country: Netherlands
facility: Pfizer Investigational Site
city: Hengelo
country: Netherlands
facility: Pfizer Investigational Site
city: Hilvarenbeek
country: Netherlands
facility: Pfizer Investigational Site
city: Hilversum
country: Netherlands
facility: Pfizer Investigational Site
city: Hilversum
country: Netherlands
facility: Pfizer Investigational Site
city: Hoofddorp
country: Netherlands
facility: Pfizer Investigational Site
city: Hoogezand
country: Netherlands
facility: Pfizer Investigational Site
city: Hoorn
country: Netherlands
facility: Pfizer Investigational Site
city: Hoorn
country: Netherlands
facility: Pfizer Investigational Site
city: Hoorn
country: Netherlands
facility: Pfizer Investigational Site
city: Houten
country: Netherlands
facility: Pfizer Investigational Site
city: Kampen
country: Netherlands
facility: Pfizer Investigational Site
city: Katwijk
country: Netherlands
facility: Pfizer Investigational Site
city: Kerkrade
country: Netherlands
facility: Pfizer Investigational Site
city: Leek
country: Netherlands
facility: Pfizer Investigational Site
city: Leeuwarden
country: Netherlands
facility: Pfizer Investigational Site
city: Leeuwarden
country: Netherlands
facility: Pfizer Investigational Site
city: Leiden
country: Netherlands
facility: Pfizer Investigational Site
city: Leiden
country: Netherlands
facility: Pfizer Investigational Site
city: Leiden
country: Netherlands
facility: Pfizer Investigational Site
city: Leiderdorp
country: Netherlands
facility: Pfizer Investigational Site
city: Maarssen
country: Netherlands
facility: Pfizer Investigational Site
city: Maastricht
country: Netherlands
facility: Pfizer Investigational Site
city: Maastricht
country: Netherlands
facility: Pfizer Investigational Site
city: Medemblik
country: Netherlands
facility: Pfizer Investigational Site
city: Nieuwegein
country: Netherlands
facility: Pfizer Investigational Site
city: Nieuwegein
country: Netherlands
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Noordwijk
country: Netherlands
facility: Pfizer Investigational Site
city: Oldenzaal
country: Netherlands
facility: Pfizer Investigational Site
city: Oosterhout
country: Netherlands
facility: Pfizer Investigational Site
city: Peize
country: Netherlands
facility: Pfizer Investigational Site
city: Rheden
country: Netherlands
facility: Pfizer Investigational Site
city: Riel
country: Netherlands
facility: Pfizer Investigational Site
city: Rijsbergen
country: Netherlands
facility: Pfizer Investigational Site
city: Rijssen
country: Netherlands
facility: Pfizer Investigational Site
city: Roden
country: Netherlands
facility: Pfizer Investigational Site
city: Roermond
country: Netherlands
facility: Pfizer Investigational Site
city: Roermond
country: Netherlands
facility: Pfizer Investigational Site
city: Roermond
country: Netherlands
facility: Pfizer Investigational Site
city: Roosendaal
country: Netherlands
facility: Pfizer Investigational Site
city: Roosendaal
country: Netherlands
facility: Pfizer Investigational Site
city: Schoorl
country: Netherlands
facility: Pfizer Investigational Site
city: Simpelveld
country: Netherlands
facility: Pfizer Investigational Site
city: Sittard
country: Netherlands
facility: Pfizer Investigational Site
city: Sittard
country: Netherlands
facility: Pfizer Investigational Site
city: Sleen
country: Netherlands
facility: Pfizer Investigational Site
city: Soest
country: Netherlands
facility: Pfizer Investigational Site
city: Son
country: Netherlands
facility: Pfizer Investigational Site
city: Spaubeek
country: Netherlands
facility: Pfizer Investigational Site
city: Steenbergen
country: Netherlands
facility: Pfizer Investigational Site
city: Tiel
country: Netherlands
facility: Pfizer Investigational Site
city: Tilburg
country: Netherlands
facility: Pfizer Investigational Site
city: Tilburg
country: Netherlands
facility: Pfizer Investigational Site
city: Tilburg
country: Netherlands
facility: Pfizer Investigational Site
city: Uithoorn
country: Netherlands
facility: Pfizer Investigational Site
city: Urmond
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Veldhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Veldhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Veldhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Velp
country: Netherlands
facility: Pfizer Investigational Site
city: Venlo
country: Netherlands
facility: Pfizer Investigational Site
city: Venlo
country: Netherlands
facility: Pfizer Investigational Site
city: Waalwijk
country: Netherlands
facility: Pfizer Investigational Site
city: Warmenhuizen
country: Netherlands
facility: Pfizer Investigational Site
city: Weert
country: Netherlands
facility: Pfizer Investigational Site
city: Woerden
country: Netherlands
facility: Pfizer Investigational Site
city: Zeist
country: Netherlands
facility: Pfizer Investigational Site
city: Zeist
country: Netherlands
facility: Pfizer Investigational Site
city: Zeist
country: Netherlands
facility: Pfizer Investigational Site
city: Zevenaar
country: Netherlands
facility: Pfizer Investigational Site
city: Zutphen
country: Netherlands
facility: Pfizer Investigational Site
city: Zutphen
country: Netherlands
facility: Pfizer Investigational Site
city: Zwolle
country: Netherlands
facility: Pfizer Investigational Site
city: Zwolle
country: Netherlands
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.