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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00744263
First received: August 27, 2008
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pneumonia, Pneumococcal
Pneumococcal Infections
13-valent Pneumococcal Vaccine
 Biological: VACCINE: placebo
Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 84496
Study Start Date: September 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Biological: VACCINE: placebo
0.5 mL, single intra-muscular injection
Experimental: 13-valent pneumococcal conjugate vaccine Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
0.5 mL, single intra-muscular injection
Other Name: 13vPnC

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744263

  Show 162 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00744263     History of Changes
Other Study ID Numbers: 6115A1-3006, B1851025
Study First Received: August 27, 2008
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pneumococcal Infections
Pneumonia
Pneumonia, Pneumococcal
Streptococcal Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumonia, Bacterial

ClinicalTrials.gov processed this record on May 23, 2013