CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 86 enrolled
Drug / intervention
PCV7 + PPV23, 2 months +1 morebiological
Likely dose
PCV7 + PPV23 administered at 2 months and 6 months intervalsAI-extracted
Key inclusion· 2
  • Age 55 to 70 years
  • Alaska Native ethnicity
Key exclusion· 4
  • Immune compromising condition
  • Neurological disease
  • Immune suppressive medication or immunoglobulin within 6 months
  • Previous pneumococcal vaccination

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00153543
NCT00153543Phase 1Completed

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

Centers for Disease Control and Prevention·interventional·Posted Sep 12, 2005·Updated Oct 1, 2024

In Brief

A Phase 1 clinical trial evaluating PCV7 + PPV23, 2 months and PCV7 + PPV23, 6 months for Pneumococcal Infections. Completed, enrolled 86 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartMay 1, 2002
Primary CompletionJun 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.8 years ago

Interventions

PCV7 + PPV23, 2 monthsbiological

PCV7 + PPV23, 6 monthsbiological