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NCT06698198 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
A Phase 1 study of Pneumococcal Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 175
- Enrollment target
- 2
- Study locations
NCT06698198: Completed Phase 1 study of Pneumococcal Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06698198 is a Phase 1 study of Pneumococcal Immunization that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 175 participants, below the 1,538-participant average among 3 other Pneumococcal Immunization trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06698198, a Phase 1 study of Pneumococcal Immunization, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 175 participants
- Enrollment target
- 2
- Study locations
Study Summary
This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy Adults (19-49 years) in the United States.
Primary Outcome
Occurrence of any unsolicited (spontaneously reported) systemic Adverse Events (AEs) reported in the 30 minutes after injection of a SP0202 formulation or Prevnar 13.
Conditions Studied
Interventions
- BIOLOGICAL Prevnar 13®
- BIOLOGICAL Pneumococcal Conjugate Vaccine
Study Locations (2)
Louisiana
- Investigational Site Number: 0002 - Metairie
New Jersey
- Investigational Site Number: 0001 - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 1 |
What the finished NCT06698198 record still lists
NCT06698198 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 1,538-participant average among 3 other Pneumococcal Immunization trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Pneumococcal Immunization appearing as the primary indexed condition, and to 2 interventions - of which Prevnar 13® is the first listed.
NCT06698198 reports a single indexed study location in Louisiana, New Jersey.
Frequently Asked Questions
What is clinical trial NCT06698198 about?
NCT06698198 is a clinical study titled "Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)". This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy Adults (19-49 years) in the United States.
What is the current status of trial NCT06698198?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 175 participants. The study started on 2018-12-03. Estimated completion is 2019-09-30.
What conditions does trial NCT06698198 study?
This clinical trial studies the following conditions: Pneumococcal Immunization.
What interventions are being tested in trial NCT06698198?
The interventions under investigation include: Prevnar 13® (BIOLOGICAL), Pneumococcal Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06698198?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06698198 being conducted?
This trial has 2 study locations across Louisiana, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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