New vaccine aims to protect kids from pneumonia – study underway

NCT ID NCT06838000

Vaccine Sponsor: Sanofi Pasteur, a Sanofi Company Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new 21-valent pneumococcal vaccine (PCV21) in healthy infants, toddlers, children, and adolescents who need catch-up vaccination. Around 1,268 participants will receive either PCV21 or the current 20-valent vaccine. Researchers will monitor side effects and measure immune responses to see if PCV21 is safe and effective.

What this could mean

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

Active substance: 21-valent pneumococcal conjugate vaccine (PCV21)
What this could lead to: If successful, this vaccine could provide better protection against pneumococcal infections for children who missed earlier doses, potentially reducing serious illnesses like pneumonia and meningitis.
What could go wrong: This is a phase 3 trial, but it focuses on immune response and safety, not direct disease prevention. The vaccine may not prove more effective than existing ones, and side effects like injection site reactions or fever are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,268 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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

7 months to 17 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: AGE * Aged 7 months to 17 years on the day of inclusion TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS * Participants who are healthy as determined by medical evaluation including medical history and physical examination For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable as assessed by the investigator SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY TESTING REQUIREMENTS For adolescents (6 to 17 YoA) only * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or surgically sterile. OR * Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study vaccine administration until at least 4 weeks after the study vaccine administration. A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours of before the first dose of study vaccine. INFORMED CONSENT * Assent form has been signed and dated by the participant (based on local regulations), and if applicable, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (LAR) and by an independent witness, if required by local regulations OTHER INCLUSIONS * Participant and parent(s) / LAR(s) are able to attend all scheduled visits and to comply with all study procedures Exclusion Criteria: MEDICAL CONDITIONS * 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 * History of microbiologically confirmed S. pneumoniae infection or disease * History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and cerebral palsy * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a product containing any of the same substances * Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent(s) / LAR(s), contraindicating intramuscular (IM) injection * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion * Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccine administration. For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only * Previous vaccination against S. pneumonia For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only * Previous vaccination with pneumococcal polysaccharide vaccine For adolescents (6 to 17 YoA) only * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion PRIOR/CONCOMITANT THERAPY * Receipt of any vaccine in the 4 weeks preceding the vaccine administration or planned receipt of any vaccine in the 4 weeks following the vaccine administration, except for US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations * Receipt of immune globulins, blood or blood-derived products in the past 3 months For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE * Participation at the time of study enrollment (or in the 6 weeks preceding the first vaccine administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure OTHER EXCLUSIONS For adolescents (6 to 17 YoA) only * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * 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 is not intended to contain all considerations relevant to a patient'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 infections

Contacts and locations

Locations

Site # 2330001

Paide, Järvamaa, 72713, Estonia
Site # 2330002

Tallinn, Harju, EE-10617, Estonia
Site # 2330003

Tallinn, Harju, EE-10617, Estonia
Site # 2330004

Tartu, 50708, Estonia
Site # 2330005

Tartu, Tartu, 50106, Estonia
Site # 2330006

Tallinn, Harju, 10117, Estonia
Site # 2330007

Tallinn, Harju, 13619, Estonia
Site # 6160001

Torun, 87-100, Poland
Site # 6160002

Bydgoszcz, 85-048, Poland
Site # 6160003

Częstochowa, Silesian Voivodeship, 42-200, Poland
Site # 6160004

Bydgoszcz, 85-796, Poland
Site # 6160006

Kłodzko, 57-300, Poland
Site # 6160007

Warsaw, Masovian Voivodeship, 03-291, Poland
Site # 6160009

Lodz, Lodskie, 91-341, Poland
Site # 7640001

Pathum Thani, Thailand
Site # 7640002

Hat Yai, Changwat Songkhla, 90112, Thailand
Site # 7640003

Mueang Nonthaburi, Chiang Mai, 50200, Thailand
Site # 7640004

Chiang Mai, 50200, Thailand
Site # 7640006

Bangkok, 10400, Thailand
Site # 7640007

Bangkok, 10400, Thailand
Site # 7640008

Bangkok, 10270, Thailand
Site # 8400001

Houston, Texas, 77065, United States
Site # 8400002

Omaha, Nebraska, 68114, United States
Site # 8400003

Sioux City, Iowa, 51106, United States
Site # 8400004

Union City, Georgia, 30291, United States
Site # 8400007

Hialeah, Florida, 33012, United States
Site # 8400008

Paramount, California, 90723, United States
Site # 8400009

Miami, Florida, 33166, United States
Site # 8400012

Ridgeland, Mississippi, 39531, United States
Site # 8400014

Melbourne, Florida, 32934, United States
Site # 8400016

Miami, Florida, 33166, United States
Site # 8400017

Stephenville, Texas, 76401, United States
Site # 8400018

Biloxi, Mississippi, 39531, United States
Site # 8400021

Fayetteville, Georgia, 30214, United States
Site # 8400023

Erlanger, Kentucky, 41018, United States
Site # 8400024

Doral, Florida, 33166, United States
Site # 8400025

Rochester, New York, 14642, United States
Site #8400010

Binghamton, New York, 13905, United States

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