CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein +1 morebiological
Likely dose
Pneumococcal 13-valent conjugate vaccine (Prevnar 13) or Pneumococcal 23-valent polysaccharide vaccine (Pneumovax 23), as randomly assigned; optional second dose 1-2 years laterAI-extracted
Key inclusion· 3
  • ✓Age 60 years or older
  • ✓Willing to receive randomly-assigned pneumococcal vaccination (Prevnar 13 or Pneumovax 23)
  • ✓Able to attend 6 study visits over 67 days
Key exclusion· 14
  • ✕Prior pneumococcal vaccination with Prevnar 13 or Pneumovax 23
  • ✕Anaphylactic or severe allergic reaction to vaccine components, diphtheria toxoid-containing vaccine
  • ✕Established diagnosis of diabetes
  • ✕Zostavax (shingles vaccine) within 4 weeks prior

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

Search/NCT03104075
NCT03104075Phase 4Completed
CompareCT.gov

Genomics and Epigenomics of the Elderly Response to Pneumococcal Vaccines

The Jackson Laboratory·interventional·Posted Apr 7, 2017·Updated Aug 22, 2025

In Brief

A Phase 4 clinical trial evaluating Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein and Pneumococcal Vaccine Polyvalent for Pneumonia and Aging. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This is a prospective, single-site, randomized, then open-label study designed to develop a detailed transcriptional and epigenetic profile of the immune response to pneumococcal vaccination with conjugated and non-conjugated polysaccharide vaccines in the senescent immune system of older adults. In this study, 40 healthy adults ages 60 and older that have never received pneumococcal vaccination, will be randomized in a 1:1 ratio to receive Prevnar-13 (Pfizer), a conjugated 13-valent vaccine or Pneumovax 23 (Merck), a non-conjugated 23-valent vaccine. Following randomized assignment of vaccine, the study will be open-label. Six (6) study visits will occur over about 70 days, with an optional 7th visit for participants to receive a second vaccination with the other pneumococcal vaccine one to two years after randomization. Participants will provide blood samples for transcriptional, epigenetic and biological analyses pre- and post-vaccination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia, Aging
CountriesUnited States
CollaboratorsUConn Health, University of Alabama at Birmingham

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 7, 2017
Enrollment StartApr 17, 2017
Primary CompletionDec 5, 2019
Study CompletionAug 29, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.2 years ago

Interventions

Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Proteinbiological

One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Pneumovax 23

Pneumococcal Vaccine Polyvalentbiological

One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Prevnar-13