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Safety and Immunogenicity of SP0202 in Healthy Adults 50-84 Years
NCT04583618Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2020
- Primary completion
- Aug 2021
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Drugs
- SP0202
- Conditions
- pneumococcal disease
01
Overview
Phase 2, randomised trial of SP0202 in pneumococcal disease (5 arms), sponsored by Sanofi. Primary endpoints: Geometric Mean Titers of Pneumococcal Serotypes Using Serotype-Specific MOPA at Day 31, Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA at Day 31 and 7 more. Started Oct 2020; status: completed.
02
Design
5 arms- Study design
- Randomized
SP0202 Formulation IIb
Single dose of SP0202 Formulation IIb
SP0202 Formulation VI
Single dose of SP0202 Formulation VI
SP0202 Formulation VII
Single dose of SP0202 Formulation VII
Prevnar 13
Single dose of Prevnar 13
Pneumovax 23
Single dose of Pneumovax 23
03
Who it enrols
Healthy adults aged 50-84 without prior pneumococcal vaccination or recent immune-modulating therapy.
04
Endpoints
Primary
Geometric Mean Titers of Pneumococcal Serotypes Using Serotype-Specific MOPA
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Geometric Mean Concentrations of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Number of Participants With Immediate Unsolicited Systemic Adverse Events
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