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
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 April 15, 2014