CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 750 enrolled
Drug / intervention
Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04583618
NCT04583618Phase 2Completed
CompareCT.gov

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

Sanofi·interventional·Posted Oct 12, 2020·Updated Sep 8, 2025

In Brief

A Phase 2 clinical trial evaluating Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb, Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI, and 3 other interventions for Pneumococcal Immunization. Completed, enrolled 750 participants across 17 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Immunization
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedOct 12, 2020
Enrollment StartOct 8, 2020
Primary CompletionAug 9, 2021
Study CompletionJan 20, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.7 years ago

Interventions

Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIbbiological

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VIbiological

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VIIbiological

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

Pneumococcal 13 - valent conjugate vaccine-Prevnar 13biological

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

Pneumococcal Vaccine Polyvalent-Pneumovax 23biological

Pharmaceutical form:Solution for injection Route of administration: intramuscular