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

Last updated on December 5, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Tilburg, Noord Brabant, 5022 JB Netherlands
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Pneumonia, Pneumococcal Infections, 13-valent Pneumococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00744263
Pfizer
Completed
Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults

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1-800-718-1021

[email protected]

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18+
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Descriptive Information
Brief Title  ICMJE Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
Official Title  ICMJE 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
Brief SummaryThe 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pneumonia, Pneumococcal
  • Pneumococcal Infections
  • 13-valent Pneumococcal Vaccine
Intervention  ICMJE
  • Biological: VACCINE: placebo
    0.5 mL, single intra-muscular injection
  • Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
    0.5 mL, single intra-muscular injection
    Other Name: 13vPnC
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Biological: VACCINE: placebo
  • Experimental: 13-valent pneumococcal conjugate vaccine
    Intervention: Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2010)
84496
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2008)
85000
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion DateOctober 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00744263
Other Study ID Numbers  ICMJE 6115A1-3006
B1851025
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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