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
  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:


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
Study Completion Date: October 2013
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744263

  Show 159 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: June 13, 2014
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 August 28, 2014