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NCT03104075 · ClinicalTrials.gov registry record · Phase 4
Genomics and Epigenomics of the Elderly Response to Pneumococcal Vaccines
A Phase 4 study, sponsored by The Jackson Laboratory.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT03104075: Completed Phase 4 study, sponsored by The Jackson Laboratory.
NCT03104075 is a Phase 4 study that has completed, run by The Jackson Laboratory. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03104075, a Phase 4 study, has completed, sponsored by The Jackson Laboratory.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
To vaccinate healthy older participants with pneumococcal vaccines, collect longitudinal blood samples and assess pneumococcal-specific antibody responses. The unit of measurement used is log2 titer defined as a measure to quantify the overall strength of responses using the sum of all serotype responses. Data shown below is from longitudinal study timepoints (pre and post) first pneumococcal vaccine. At study endpoint, Visit 7, a second pneumococcal vaccine was administered and no further sampl
Interventions
- BIOLOGICAL Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein
- BIOLOGICAL Pneumococcal Vaccine Polyvalent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-04-17 |
| Est. Completion | 2020-08-29 |
| Phase | Phase 4 |
What the finished NCT03104075 record still lists
NCT03104075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein is the first listed.
NCT03104075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03104075 about?
NCT03104075 is a clinical study titled "Genomics and Epigenomics of the Elderly Response to Pneumococcal Vaccines". 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. I...
What is the current status of trial NCT03104075?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2017-04-17. Estimated completion is 2020-08-29.
What interventions are being tested in trial NCT03104075?
The interventions under investigation include: Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein (BIOLOGICAL), Pneumococcal Vaccine Polyvalent (BIOLOGICAL).
Who is sponsoring clinical trial NCT03104075?
This trial is sponsored by The Jackson Laboratory, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03104075's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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