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New pneumonia vaccine shows promise in toddlers and infants

NCT ID NCT04398706

Vaccine Sponsor: Sanofi Pasteur, a Sanofi Company 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This completed Phase 2 trial tested three new formulations of a pneumococcal conjugate vaccine (SP0202) in 852 healthy toddlers and infants. The goal was to see if these vaccines are safe and produce a strong immune response when given alongside routine childhood vaccines. Researchers compared the new vaccines to an existing one (Prevnar 13) and monitored side effects and antibody levels.

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)
What this could lead to
If successful, this could lead to a new vaccine option to protect young children against pneumococcal disease.
What could go wrong
This is a Phase 2 trial, so it is still early. The new vaccine may not work better than existing ones, and side effects 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 2

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

Participants

852 people

The number who actually took part.

Started

May 2020

Finished

Aug 2023

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 days to 15 months

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 : Toddlers and infants: * Participant and parent/guardian are able to attend all scheduled visits and to comply with all study procedures * Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 5.5 lbs or 2.5 kg Specifically for toddlers: * Aged 12 to 15 months on the day of the first study visit * Participant has received 3 doses of Prevnar 13 and 3 doses of diphteria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b antigens in infancy Specifically for infants: \- Aged 42 to 89 days on the day of the first study visit Exclusion criteria: Toddlers and infants * Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure * Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated * Blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems * Active tuberculosis * History of S. pneumoniae infection or disease, confirmed either serologically or microbiologically * History of any neurologic disorder, including any seizures and progressive neurologic disorders * History of Guillain-Barré syndrome * Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances * Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and know congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion * Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives * In an emergency setting, or hospitalized involuntarily * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C / ≥ 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 resolved * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study Specifically for toddlers * Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 2), except for 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 * Receipt of 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 diphtheria, tetanus, pertussis, poliomyelitis, and/or H. influenzae type b infection or disease Specifically for infants * Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 6), except for influenza vaccination or COVID-19 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, and COVID-19 vaccines as applicable per local recommendations * Receipt of immune globulins, blood or blood-derived products since birth. * 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 (prednisone or equivalent for more than 2 consecutive weeks) since birth * Previous vaccination against S. pneumoniae * Previous vaccination against the following antigens: diphteria, tetanus, pertussis, H. influenzae type b, poliovirus, rotavirus, measles, mumps, rubella, and varicella * Receipt of more than 1 previous dose of hepatitis B vaccine * History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, varicella, H. influenzae type b, and/or rotavirus infection or disease * History of intussusception 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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As listed by the trial registrant

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

Diphtheria immunisation Haemophilus influenzae type B immunisation Hepatitis B immunisation Measles immunisation Mumps immunisation Pertussis immunisation Pneumococcal immunisation Polio immunisation Rubella immunisation Tetanus immunisation Varicella immunisation

Contacts and locations

Locations

  • Amber Clinical Research, LLC Site Number : 8400019

    Miami, Florida, 33164, United States

  • Ardmore Medical Research Site Number : 8400043

    Winston-Salem, North Carolina, 27103, United States

  • Atrium Health Site Number : 8400124

    Charlotte, North Carolina, 28204, United States

  • Benchmark Research San Antonio Site Number : 8400129

    San Antonio, Texas, 78201, United States

  • Benchmark Research Site Number : 8400012

    Covington, Louisiana, 70433, United States

  • Bingham Memorial Hospital Site Number : 8400067

    Blackfoot, Idaho, 83221, United States

  • Biopharma Informatic Site Number : 8400066

    McAllen, Texas, 78503, United States

  • Boeson Research Site Number : 8400004

    Missoula, Montana, 59804, United States

  • California Research Foundation Site Number : 8400052

    San Diego, California, 92123-1881, United States

  • Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062

    Columbus, Georgia, 31904, United States

  • Cheraw Pediatrics Site Number : 8400017

    Cheraw, South Carolina, 29520, United States

  • Children's Mercy Hospital Site Number : 8400008

    Kansas City, Missouri, 64108, United States

  • DCOL Center for Clinical Research Site Number : 8400107

    Longview, Texas, 75605, United States

  • Dade Research Center Site Number : 8400122

    Miami, Florida, 33135, United States

  • Dumog Research Site Number : 8400134

    Smyrna, Georgia, 30080, United States

  • FMC Science, LLC Site Number : 8400086

    Lampasas, Texas, 76550-1820, United States

  • Homestead Medical Clinic, P.A. Site Number : 8400032

    Homestead, Florida, 33030, United States

  • Houston Clinical Research Associates Site Number : 8400023

    Houston, Texas, 77090, United States

  • Hutchinson Clinic Site Number : 8400074

    Hutchinson, Kansas, 67502, United States

  • International Research Partners, LLC Site Number : 8400077

    Doral, Florida, 33122, United States

  • Investigational Site Number : 1240001

    Halifax, Nova Scotia, B3K6R8, Canada

  • Investigational Site Number : 1240002

    Vancouver, British Columbia, V5Z4H4, Canada

  • Investigational Site Number : 1240006

    Hamilton, Ontario, L8M 1K7, Canada

  • Investigational Site Number : 3400001

    San Pedro Sula, 21104, Honduras

  • Investigational Site Number : 3400002

    Municipio Del Distrito Central, 11101, Honduras

  • Investigational Site Number : 6300001

    San Juan, 00935, Puerto Rico

  • Investigational Site Number : 6300002

    Bayamón, 00961, Puerto Rico

  • Investigational Site Number : 6300004

    Guayama, 000784, Puerto Rico

  • Javara Albany Site Number : 8400140

    Albany, Georgia, 31707, United States

  • Javara Annapolis Site Number : 8400137

    Annapolis, Maryland, 21401, United States

  • Javara Chevy Chase Site Number : 8400138

    Chevy Chase, Maryland, 20815, United States

  • Javara Dallas Site Number : 8400135

    Dallas, Texas, 75230, United States

  • Javara Fayetteville Site Number : 8400139

    Fayetteville, Georgia, 30214, United States

  • Jedidiah Clinical Research Site Number : 8400049

    Tampa, Florida, 33617, United States

  • Joint Clinical Trials Huntington Park Site Number : 8400030

    Huntington Park, California, 90255, United States

  • Leavitt Clinical Research Site Number : 8400127

    Idaho Falls, Idaho, 83404, United States

  • Lincoln Pediatric Group Site Number : 8400125

    Lincoln, Nebraska, 68516, United States

  • Matrix Clinical Research Huntington Park Site Number : 8400058

    Huntington Park, California, 90255, United States

  • Matrix Clinical Research Site Number : 8400059

    Los Angeles, California, 90057, United States

  • Meridian Clinical Research Site Number : 8400102

    Grand Island, Nebraska, 68803, United States

  • Meridian Clinical Research Washington DC Site Number : 8400119

    Washington D.C., District of Columbia, 20016, United States

  • Meridian Clinical Research, LLC Site Number : 8400112

    Baton Rouge, Louisiana, 70806, United States

  • Miami Clinical Research Site Number : 8400020

    Miami, Florida, 33155, United States

  • Michael W. Simon, MD, PSC Site Number : 8400002

    Lexington, Kentucky, 40517, United States

  • MultiCare Institute for Research & Innovation Site Number : 8400024

    Spokane, Washington, 99202, United States

  • North Texas Clinical Trials Site Number : 8400015

    Fort Worth, Texas, 76104, United States

  • Orange County Research Institute Site Number : 8400060

    Ontario, California, 91762, United States

  • Pediatric Associates of Mt. Carmel Site Number : 8400005

    Cincinnati, Ohio, 45245, United States

  • Pediatric Infectious Diseases Research Site Number : 8400104

    Omaha, Nebraska, 68131, United States

  • Pininos Pediatric Services Site Number : 8400121

    El Paso, Texas, 79902, United States

  • Qualmedica Research, LLC Site Number : 8400084

    Bowling Green, Kentucky, 42101, United States

  • Southland Clinical Research Center Site Number : 8400040

    Bellflower, California, 90706, United States

  • Sun Research Institute Site Number : 8400011

    San Antonio, Texas, 78205, United States

  • Tekton Research Site Number : 8400076

    San Antonio, Texas, 78244, United States

  • The Children's Clinic Of Jonesboro PA Site Number : 8400143

    Jonesboro, Arkansas, 72401, United States

  • Tribe Clinical Research Site Number : 8400025

    Greenville, South Carolina, 29607, United States

  • Velocity Clinical Research Lafayette Site Number : 8400132

    Lafayette, Louisiana, 70508, United States

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