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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 is a Phase 4 study that has completed, run by The Jackson Laboratory. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03104075
The ClinicalTrials.gov registry entry for NCT03104075 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Jackson Laboratory, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein is the first listed.
NCT03104075 reports 0 study locations.
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.
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