NCT04583618

Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.

Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults Aged 50 to 84 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 50 Years – 84 Years
• Healthy volunteers: Accepted

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

Detailed description

The duration of each participant's participation was approximately 6 months.

Conditions

• Pneumococcal Immunization

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb	Pharmaceutical form:Suspension for injection Route of administration: intramuscular
BIOLOGICAL	Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI	Pharmaceutical form:Suspension for injection Route of administration: intramuscular
BIOLOGICAL	Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII	Pharmaceutical form:Suspension for injection Route of administration: intramuscular
BIOLOGICAL	Pneumococcal 13 - valent conjugate vaccine-Prevnar 13	Pharmaceutical form:Suspension for injection Route of administration: intramuscular
BIOLOGICAL	Pneumococcal Vaccine Polyvalent-Pneumovax 23	Pharmaceutical form:Solution for injection Route of administration: intramuscular

Timeline

• Start date: 2020-10-08
• Primary completion: 2021-08-09
• Completion: 2022-01-20
• First posted: 2020-10-12
• Last updated: 2025-09-08
• Results posted: 2024-08-27

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study