Immunogenicity and Reactogenicity of Pneumococcal Polysaccharide and Conjugate Vaccines in Native Elders

This study has been completed.
Sponsor:
Collaborators:
Alaska Native Tribal Health Consortium
Southcentral Foundation
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00153543
First received: September 8, 2005
Last updated: March 19, 2007
Last verified: September 2005
  Purpose

To test the hypothesis that immune responses to 23-valent pneumococcal polysaccharide vaccine (PPV-23) could be improved in Alaska Native elders by immune priming with 7-valent pneumococcal conjugate vaccine (PCV-7), we assessed post-vaccination immune responses among Natives aged 55 years and older who were randomized into three arms: (1) one dose of PPV-23 according to current state and ACIP recommendations; (2) one dose of PCV-7 followed two months later with a dose of PPV-23; and (3) one dose of PCV-7 followed six months later with a dose of PPV-23.


Condition Intervention Phase
Pneumococcal Infections
Biological: Pneumococcal polysaccharide vaccine
Biological: Pneumococcal conjugate vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Reactogenicity of Pneumococcal Polysaccharide and Conjugate Vaccines in Native Elders

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Immune responses

Secondary Outcome Measures:
  • Systemic and injection site reactions

Estimated Enrollment: 90
Study Start Date: May 2002
Estimated Study Completion Date: June 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 55 to 70 years
  • Alaska Native

Exclusion Criteria:

  • Immune compromising condition
  • Neurological disease
  • Immune suppressive medication or immunoglobulin within 6 months
  • Previous pneumococcal vaccination
  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: NCT00153543

Locations
United States, Alaska
Alaska Native Medical Center
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Alaska Native Tribal Health Consortium
Southcentral Foundation
Investigators
Principal Investigator: Karen Miernyk, MS Alaska Native Tribal Health Consortium
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00153543     History of Changes
Other Study ID Numbers: CDC-NCID-3316
Study First Received: September 8, 2005
Last Updated: March 19, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 22, 2014