New pneumonia vaccine shows promise in older adults

NCT ID NCT04583618

Vaccine Sponsor: Sanofi Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested three new pneumococcal vaccine formulations in 750 healthy adults aged 50 to 84. The goal was to see how well they trigger an immune response and how safe they are compared to two existing vaccines. Participants received a single shot, and researchers measured antibody levels and tracked side effects for one month.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Pneumococcal conjugate vaccine (SP0202 formulations)
What this could lead to: If successful, this could lead to a new vaccine option that protects older adults against pneumococcal disease, potentially offering broader or stronger immunity than current vaccines.
What could go wrong: This is a Phase 2 trial, so results are preliminary. The new vaccine may not prove more effective or safer than existing ones in larger Phase 3 studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

750 people

The number who actually took part.

Started

Oct 2020

Finished

Jan 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 84 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : \- Aged 50 to 84 years on the day of inclusion . Exclusion criteria: * Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, the female must have been post-menopausal for at least 1 year, or surgically sterile. * 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.

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Conditions

The condition(s) this trial relates to.

pneumococcal infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pneumococcal immunization

Contacts and locations

Locations

Advanced Clinical Research - Magic View Site Number : 8400003

Meridian, Idaho, 83642, United States
Aventiv Research Columbus Site Number : 8400007

Columbus, Ohio, 43213, United States
Be Well Clinical Studies Site Number : 8400018

Lincoln, Nebraska, 68516, United States
Biotrial Inc Site Number : 8400006

Newark, New Jersey, 07103, United States
Coastal Carolina Research Center - N Charleston Site Number : 8400004

North Charleston, South Carolina, 29405, United States
Emmaus Research Center, Inc Site Number : 8400014

Anaheim, California, 92804, United States
JBR Clinical Research Site Number : 8400008

Salt Lake City, Utah, 84107, United States
Jacksonville Center for Clinical Research Site Number : 8400016

Jacksonville, Florida, 32216, United States
Paradigm Clinical Research Center Wheat Ridge Site Number : 8400002

Wheat Ridge, Colorado, 80033, United States
Peninsula Research Associates Site Number : 8400012

Rolling Hills Estates, California, 90274, United States
Plains Clinical Research Center, LLC Site Number : 8400011

Fargo, North Dakota, 58104, United States
Preferred Primary Care Physicians Site Number : 8400009

Pittsburgh, Pennsylvania, 15236, United States
Suncoast Research Associates, LLC Site Number : 8400017

Miami, Florida, 33173, United States
Velocity Clinical Research Site Number : 8400005

Metairie, Louisiana, 70006, United States
Velocity Clinical Research Valparaiso Site Number : 8400001

Valparaiso, Indiana, 46383, United States
Velocity Clinical Research, Medford Site Number : 8400010

Medford, Oregon, 97504, United States
WR-CRCN, LLC Site Number : 8400013

Las Vegas, Nevada, 89106, United States

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