Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.
NCT ID: NCT04583618
Last Updated: 2025-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
750 participants
INTERVENTIONAL
2020-10-08
2022-01-20
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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SP0202-IIb
One dose at Day 1
Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
SP0202-VI
One dose at Day 1
Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
SP0202-VII
One dose at Day 1
Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Prevnar 13
One dose at Day 1
Pneumococcal 13 - valent conjugate vaccine-Prevnar 13
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumovax 23
One dose at Day 1
Pneumococcal Vaccine Polyvalent-Pneumovax 23
Pharmaceutical form:Solution for injection Route of administration: intramuscular
Interventions
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Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal 13 - valent conjugate vaccine-Prevnar 13
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal Vaccine Polyvalent-Pneumovax 23
Pharmaceutical form:Solution for injection Route of administration: intramuscular
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Participation at the time of the study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure.
* Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit, except for influenza vaccination, which may be received at least 2 weeks before study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
* Previous vaccination against S. pneumoniae with either a pneumococcal conjugated vaccine (PCV) or a pneumococcal polysaccharide vaccine (PPSV).
* Received immune globulins, blood or blood-derived products in the past 3 months.
* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* History of S. pneumoniae infection or disease, confirmed either serologically, or microbiologically.
* History of Guillain-Barré syndrome occurring within 6 weeks after a prior dose of a TTxd-containing vaccine.
* Experienced an Arthus-type hypersensitivity reaction following a prior dose of a TTxd-containing vaccine \< 10 years ago.
* Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances .
* Verbal report of thrombocytopenia contraindicating IM vaccination in the Investigator's opinion.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion.
* At risk of invasive pneumococcal disease (eg, participants with functional or anatomic asplenia, participants with severe asthma, participants travelling to countries with high endemicity).
* Current alcohol abuse or drug addiction.
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
* Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine (eg, under investigation or monitoring for possible coronavirus disease 2019 \[COVID-19\]).
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has subsided.
* Received oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
50 Years
84 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Emmaus Research Center, Inc Site Number : 8400014
Anaheim, California, United States
Peninsula Research Associates Site Number : 8400012
Rolling Hills Estates, California, United States
Paradigm Clinical Research Center Wheat Ridge Site Number : 8400002
Wheat Ridge, Colorado, United States
Jacksonville Center for Clinical Research Site Number : 8400016
Jacksonville, Florida, United States
Suncoast Research Associates, LLC Site Number : 8400017
Miami, Florida, United States
Advanced Clinical Research - Magic View Site Number : 8400003
Meridian, Idaho, United States
Velocity Clinical Research Valparaiso Site Number : 8400001
Valparaiso, Indiana, United States
Velocity Clinical Research Site Number : 8400005
Metairie, Louisiana, United States
Be Well Clinical Studies Site Number : 8400018
Lincoln, Nebraska, United States
WR-CRCN, LLC Site Number : 8400013
Las Vegas, Nevada, United States
Biotrial Inc Site Number : 8400006
Newark, New Jersey, United States
Plains Clinical Research Center, LLC Site Number : 8400011
Fargo, North Dakota, United States
Aventiv Research Columbus Site Number : 8400007
Columbus, Ohio, United States
Velocity Clinical Research, Medford Site Number : 8400010
Medford, Oregon, United States
Preferred Primary Care Physicians Site Number : 8400009
Pittsburgh, Pennsylvania, United States
Coastal Carolina Research Center - N Charleston Site Number : 8400004
North Charleston, South Carolina, United States
JBR Clinical Research Site Number : 8400008
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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PSK00009 Plain Language Results Summary
Other Identifiers
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U1111-1238-9824
Identifier Type: REGISTRY
Identifier Source: secondary_id
PSK00009
Identifier Type: -
Identifier Source: org_study_id
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