Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
NCT06698198 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 175
Last updated 2024-11-20
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.
Conditions
- Pneumococcal Immunization
Interventions
- BIOLOGICAL
-
Pneumococcal Conjugate Vaccine
Suspension for Intramuscular injection
- BIOLOGICAL
-
Prevnar 13®
Suspension for Intramuscular injection
Sponsors & Collaborators
-
Sanofi Pasteur, a Sanofi Company
lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-12-03
- Primary Completion
- 2019-09-30
- Completion
- 2019-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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