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New vaccine combo could simplify infant shots

NCT ID NCT06824181

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 study tests whether mixing a new 21-valent pneumococcal vaccine with a licensed 20-valent version is safe and helps build immunity in healthy infants. About 580 babies will receive different combinations of the vaccines at routine checkups. The goal is to see if flexible schedules work as well as the standard series.

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) and 20-valent pneumococcal conjugate vaccine (Prevnar 20)
What this could lead to
If successful, this could show that mixing different pneumococcal vaccines is safe and effective, potentially offering more flexible vaccination schedules for infants.
What could go wrong
This is a Phase 3 trial, but results may not apply to all populations. The study is still ongoing, and the final outcomes on safety and immune response are not yet known.

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

580 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Sep 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 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 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. * History of seizure or significant stable or progressive neurologic disorders such as 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 * Thrombocytopenia, or known thrombocytopenia, as reported by the parent/legal 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. * Previous vaccination against Streptococcus pneumoniae * 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.

Pneumococcal immunization

Contacts and locations

Locations

  • Atlantis Clinical Research- Site Number : 8400009

    Miami, Florida, 33173, United States

  • Carolina Family Care - Charleston- Site Number : 8400014

    Charleston, South Carolina, 29414, United States

  • Clinsearch Inc at Dr. Gala, LLC- Site Number : 8400027

    Miami, Florida, 33135, United States

  • Clinsearch Inc at VAST Clinical Research- Site Number : 8400028

    Euless, Texas, 76040, United States

  • DM Clinical Research - Houston - Jones Road- Site Number : 8400012

    Houston, Texas, 77065, United States

  • Finger Lakes Medical Research - Cortland- Site Number : 8400022

    Cortland, New York, 13045, United States

  • Helios Clinical Research - BUR PEDI- Site Number : 8400016

    Burleson, Texas, 76028, United States

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8880465, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8380418, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 8330034, Chile

  • Investigational Site Number : 4840001

    Mexico City, Mexico City, 04530, Mexico

  • Investigational Site Number : 4840002

    Temixco, Morelos, 62587, Mexico

  • Investigational Site Number : 4840003

    León, Guanajuato, 37320, Mexico

  • Investigational Site Number : 4840004

    Tlaltizapán, Morelos, 62770, Mexico

  • Investigational Site Number : 6080001

    Cebu City, 6000, Philippines

  • Investigational Site Number : 6080002

    Quezon City, 1100, Philippines

  • Investigational Site Number : 6080003

    Quezon City, 1121, Philippines

  • Javara - Privia Medical Group North Texas - Stephenville- Site Number : 8400024

    Stephenville, Texas, 76401, United States

  • Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400025

    Los Angeles, California, 90027, United States

  • Kid's Way Pediatrics- Site Number : 8400013

    Hermitage, Pennsylvania, 16148, United States

  • Private Practice - Dr. Michael W. Simon- Site Number : 8400001

    Lexington, Kentucky, 40517, United States

  • SUNY Upstate Medical University - Syracuse- Site Number : 8400015

    Syracuse, New York, 13210, United States

  • The Medici Medical Research- Site Number : 8400008

    Hollywood, Florida, 33021, United States

  • University of Rochester Medical Center- Site Number : 8400019

    Rochester, New York, 14642, United States

  • University of Texas Medical Branch at Galveston- Site Number : 8400005

    League City, Texas, 77555, United States

  • Velocity Clinical Research - New Orleans- Site Number : 8400006

    New Orleans, Louisiana, 70119, United States

  • Velocity Clinical Research - Sioux City- Site Number : 8400007

    Sioux City, Iowa, 51106, United States

More trials for these conditions

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