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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00744263
First received: August 27, 2008
Last updated: June 13, 2014
Last verified: June 2014

August 27, 2008
June 13, 2014
September 2008
October 2013   (final data collection date for primary outcome measure)
Number of first episodes of vaccine-type pneumococcal community-acquired pneumonia in each study arm. [ Time Frame: N/A. Endpoint-driven study. ] [ Designated as safety issue: No ]
Compare number of cases of first episode vaccine-type pneumococcal community-acquired pneumonia in each study arm. [ Time Frame: No specific time; rather as long as necessary to gather sufficient data to make the protocol-required outcome assessments. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00744263 on ClinicalTrials.gov Archive Site
  • Number of first episodes of vaccine-type invasive pneumococcal disease in each study arm. [ Time Frame: /A. Endpoint-driven study. ] [ Designated as safety issue: No ]
  • Number of first episodes of nonbacteremic/noninvasive vaccine-type pneumococcal community-acquired pneumonia in each study arm. [ Time Frame: /A. Endpoint-driven study. ] [ Designated as safety issue: No ]
Compare the number of cases of vaccine-type invasive pneumococcal disease in each arm. Evaluate the acceptability of the safety profile of 13-valent as measured by the incidence rates of serious adverse events in each arm. [ Time Frame: No specific time; rather as long as necessary to gather sufficient data to make the protocol-required outcome assessments. Occurrence of serious adverse events will be assessed for 28 days following vaccination. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pneumonia, Pneumococcal
  • Pneumococcal Infections
  • 13-valent Pneumococcal Vaccine
  • 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
  • Placebo Comparator: Placebo
    Intervention: Biological: VACCINE: placebo
  • Experimental: 13-valent pneumococcal conjugate vaccine
    Intervention: Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84496
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00744263
6115A1-3006, B1851025
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP