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New 21-Valent vaccine aims to shield babies from pneumonia and meningitis

NCT ID NCT06975878

Vaccine Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new 21-valent pneumococcal conjugate vaccine (PCV21) in about 1,092 healthy infants and toddlers. The goal is to see if PCV21 is safe and helps the body produce antibodies against pneumococcal bacteria better than the current licensed vaccine. Participants receive the vaccine alongside routine childhood shots at scheduled visits from around 2 months to 15 months of age.

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

1,092 people

The number who actually took part.

Started

May 2025

Expected to finish

Aug 2027

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

42 to 112 days

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 42 to 112 days on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history and physical examination * 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 Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy * History of microbiologically confirmed Streptococcus pneumoniae infection or disease * Any contraindication to the routine pediatric vaccines being administered in the study * History of seizure or significant stable or progressive neurological disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy * Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Laboratory-confirmed or known thrombocytopenia, as reported by the parent/legally acceptable representative (LAR), 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 study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for oral rotavirus vaccine, which may be received anytime during the study including at study visits and for influenza vaccination or meningococcal b vaccine, which may be received at least 14 days before or 14 days after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations. * Previous vaccination against S. pneumoniae * Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and poliovirus * Receipt of more than 1 dose of hepatitis B vaccine * Receipt of immune globulins, blood or blood-derived products since birth * Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a 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.

Healthy volunteers Pneumococcal immunization

Contacts and locations

Locations

  • Investigational Site Number : 0560001

    Bruges, 8000, Belgium

  • Investigational Site Number : 0560002

    Edegem, 2650, Belgium

  • Investigational Site Number : 0560003

    Roeselare, 8800, Belgium

  • Investigational Site Number : 0560004

    Alken, 3570, Belgium

  • Investigational Site Number : 0560005

    Gozée, 6534, Belgium

  • Investigational Site Number : 0560007

    Leuven, 3000, Belgium

  • Investigational Site Number : 2030001

    Jindřichův Hradec, 377 01, Czechia

  • Investigational Site Number : 2030006

    Pilsen, 301 00, Czechia

  • Investigational Site Number : 2030008

    Prague, 18000, Czechia

  • Investigational Site Number : 2030009

    Krnov, 79401, Czechia

  • Investigational Site Number : 2330001

    Paide, 72713, Estonia

  • Investigational Site Number : 2330002

    Tartu, 50106, Estonia

  • Investigational Site Number : 2330004

    Tallinn, 10617, Estonia

  • Investigational Site Number : 2460001

    Helsinki, 00100, Finland

  • Investigational Site Number : 2460002

    Seinäjoki, 60100, Finland

  • Investigational Site Number : 2460003

    Kokkola, 67100, Finland

  • Investigational Site Number : 2460004

    Oulu, 90220, Finland

  • Investigational Site Number : 2460005

    Jarvenpaa, 04400, Finland

  • Investigational Site Number : 2460007

    Tampere, 33100, Finland

  • Investigational Site Number : 2460008

    Espoo, 02230, Finland

  • Investigational Site Number : 2460009

    Turku, 20520, Finland

  • Investigational Site Number : 2460010

    Helsinki, 00290, Finland

  • Investigational Site Number : 2760003

    Wolfsburg, 38448, Germany

  • Investigational Site Number : 2760005

    Herxheim, 76863, Germany

  • Investigational Site Number : 2760006

    Hürth, 50354, Germany

  • Investigational Site Number : 2760008

    Schönau am Königssee, 83471, Germany

  • Investigational Site Number : 2760010

    Mönchengladbach, 41236, Germany

  • Investigational Site Number : 2760012

    Mönchengladbach, 41236, Germany

  • Investigational Site Number : 2760013

    Krefeld, 47799, Germany

  • Investigational Site Number : 2760014

    Hürth, 50354, Germany

  • Investigational Site Number : 3000001

    Athens, 11527, Greece

  • Investigational Site Number : 3000002

    Athens, 12462, Greece

  • Investigational Site Number : 3000005

    Thessaloniki, 54642, Greece

  • Investigational Site Number : 3000006

    Ioannina, 45500, Greece

  • Investigational Site Number : 3800001

    Bari, 70124, Italy

  • Investigational Site Number : 3800002

    Rome, Roma, 00161, Italy

  • Investigational Site Number : 3800004

    Rome, Lazio, 00168, Italy

  • Investigational Site Number : 3800007

    Milan, 20122, Italy

  • Investigational Site Number : 3800008

    Foggia, 71122, Italy

  • Investigational Site Number : 3800009

    Parma, 43126, Italy

  • Investigational Site Number : 3800010

    Lecce, 73100, Italy

  • Investigational Site Number : 6160001

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

  • Investigational Site Number : 6160002

    Siemianowice Śląskie, Silesian Voivodeship, 41-103, Poland

  • Investigational Site Number : 6160003

    Trzebnica, Lower Silesian Voivodeship, 55-100, Poland

  • Investigational Site Number : 6160005

    Łomianki, Masovian Voivodeship, 05-092, Poland

  • Investigational Site Number : 6160007

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Investigational Site Number : 6160008

    Wroclaw, Lower Silesian Voivodeship, 50-368, Poland

  • Investigational Site Number : 6160009

    Krakow, Lesser Poland Voivodeship, 30-348, Poland

  • Investigational Site Number : 6160011

    Warsaw, Masovian Voivodeship, 02-647, Poland

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