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NCT04583618 · ClinicalTrials.gov registry record · Phase 2
Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 750
- Enrollment target
NCT04583618: Completed Phase 2 study, sponsored by Sanofi.
NCT04583618 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 750 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (464% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04583618, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 750 participants
- Enrollment target
Study Summary
Primary Objectives: * Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination * Assessed the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
Primary Outcome
The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution.
Interventions
- BIOLOGICAL Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb
- BIOLOGICAL Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI
- BIOLOGICAL Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII
- BIOLOGICAL Pneumococcal 13 - valent conjugate vaccine-Prevnar 13
- BIOLOGICAL Pneumococcal Vaccine Polyvalent-Pneumovax 23
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2020-10-08 |
| Est. Completion | 2022-01-20 |
| Phase | Phase 2 |
What the finished NCT04583618 record still lists
NCT04583618 is an interventional study that assigns participants to a tested intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (464% higher).
The record links to 0 conditions, and to 5 interventions - of which Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb is the first listed.
NCT04583618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04583618 about?
NCT04583618 is a clinical study titled "Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.". Primary Objectives: * Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination * Assessed the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
What is the current status of trial NCT04583618?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 750 participants. The study started on 2020-10-08. Estimated completion is 2022-01-20.
What interventions are being tested in trial NCT04583618?
The interventions under investigation include: Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb (BIOLOGICAL), Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI (BIOLOGICAL), Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII (BIOLOGICAL), Pneumococcal 13 - valent conjugate vaccine-Prevnar 13 (BIOLOGICAL), Pneumococcal Vaccine Polyvalent-Pneumovax 23 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04583618?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04583618's enrollment target sits among peer trials
750 43rd of 2000 higher than 1,957 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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