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New vaccine aims to shield infants from pneumonia

NCT ID NCT07348692

Prevention Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 vaccine (PCV21) designed to protect babies against 21 types of pneumococcal bacteria, which can cause pneumonia and other serious infections. About 2,200 healthy infants will receive four doses of either the new vaccine or an existing one starting at 2 months old. Researchers will check if the new vaccine triggers a strong immune response and is safe.

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

About 2,195 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

May 2028

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 89 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 89 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 Exclusion Criteria: * 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 vaccine being administered in the study * History of seizure or significant stable or progressive neurologic 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 substances3 * Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (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 study intervention administration. * Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period * Previous vaccination against Streptococcus pneumoniae * Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Community Clinical Research- Site Number : 8400030

    RECRUITING

    Los Angeles, California, 90008, United States

  • Investigational Site Number : 3400001

    RECRUITING

    San Pedro Sula, 21104, Honduras

  • Investigational Site Number : 3400002

    RECRUITING

    Tegucigalpa, 11101, Honduras

  • Investigational Site Number : 3400003

    RECRUITING

    Tegucigalpa, 11101, Honduras

  • Investigational Site Number : 6300005

    RECRUITING

    Guayama, 00786, Puerto Rico

  • Investigational Site Number : 6300006

    RECRUITING

    San Juan, 00918, Puerto Rico

  • Investigational Site Number : 6300007

    RECRUITING

    Trujillo Alto, 00976, Puerto Rico

  • Kentucky Pediatric Research- Site Number : 8400036

    RECRUITING

    Bardstown, Kentucky, 40004, United States

  • Matrix Clinical Research - Huntington Park- Site Number : 8400029

    RECRUITING

    Huntington Park, California, 90255, United States

  • Matrix Clinical Research - Los Angeles- Site Number : 8400028

    RECRUITING

    Los Angeles, California, 90057, United States

  • Michigan Institute of Research- Site Number : 8400004

    RECRUITING

    Allen Park, Michigan, 48101, United States

  • Northwest Arkansas Pediatric Clinic- Site Number : 8400039

    RECRUITING

    Fayetteville, Arkansas, 72703, United States

  • PAS Research - Children's Care Clinic- Site Number : 8400035

    RECRUITING

    Edinburg, Texas, 78539, United States

  • PAS Research - Tampa- Site Number : 8400034

    RECRUITING

    Tampa, Florida, 33613, United States

  • Parkside Pediatrics - Simpsonville- Site Number : 8400005

    RECRUITING

    Simpsonville, South Carolina, 29681, United States

  • Pediatric Center - Richmond- Site Number : 8400038

    RECRUITING

    Richmond, Texas, 77469, United States

  • Rio Clinical Trials - Canyon View- Site Number : 8400031

    RECRUITING

    Ogden, Utah, 84404, United States

  • Tribe Clinical Research - Spartanburg- Site Number : 8400026

    RECRUITING

    Spartanburg, South Carolina, 29301, United States

  • Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008

    RECRUITING

    Charleston, South Carolina, 29407, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.