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

NCT04583618 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2025-09-08

Study results available
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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

Conditions

  • Pneumococcal Immunization

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2021-08-09
Completion
2022-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04583618 on ClinicalTrials.gov