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New 21-Strain pneumonia vaccine shows promise in infant trial

NCT ID NCT06736041

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 vaccine (PCV21) that protects against 21 types of pneumonia-causing bacteria. About 1,700 healthy infants will receive either the new vaccine or an existing one alongside their routine shots. The goal is to see if the new vaccine is safe and helps babies build strong defenses against these infections.

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

1,714 people

The number who actually took part.

Started

Dec 2024

Expected to finish

May 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 * 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 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. * 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.

Pneumococcal immunization

Contacts and locations

Locations

  • Acevedo Clinical Research Associates- Site Number : 8400089

    Miami, Florida, 33142, United States

  • Allegheny Health Network - Health and Wellness Pavilion- Site Number : 8400111

    Erie, Pennsylvania, 16506, United States

  • Alliance for Multispeciality Research - El Dorado- Site Number : 8400010

    El Dorado, Kansas, 67042, United States

  • Bingham Memorial Hospital - Blackfoot- Site Number : 8400084

    Blackfoot, Idaho, 83221, United States

  • Bio-Medical Research- Site Number : 8400147

    Miami, Florida, 33184, United States

  • BioResearch Partner (BRP) - Premium Healthcare Medical Center - Miami Lakes- Site Number : 8400203

    Miami Lakes, Florida, 33016, United States

  • Biopharma Informatic - Katy - Katy Freeway- Site Number : 8400258

    Katy, Texas, 77450, United States

  • Century Research Institute- Site Number : 8400065

    Huntington Park, California, 90255, United States

  • Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400236

    Richmond, Virginia, 23220, United States

  • Clinical Research Prime Rexburg- Site Number : 8400250

    Rexburg, Idaho, 83440, United States

  • Coastal Carolina Research Center - North Charleston- Site Number : 8400064

    North Charleston, South Carolina, 29405, United States

  • Cotton O'Neil Pediatrics- Site Number : 8400009

    Topeka, Kansas, 66604, United States

  • Dade Research Center- Site Number : 8400007

    Miami, Florida, 33135, United States

  • Dayton Clinical Research- Site Number : 8400087

    Dayton, Ohio, 45409, United States

  • EMDA Clinical Research- Site Number : 8400237

    Miami, Florida, 33126, United States

  • Eclipse Clinical Research- Site Number : 8400029

    Tucson, Arizona, 85745, United States

  • FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063

    Ventura, California, 93003, United States

  • FamilyHealthWatch - KeyPoint Clinical Research- Site Number : 8400173

    Dallas, Texas, 75237, United States

  • Gonzalez Family & Occupational Medicine- Site Number : 8400035

    Houston, Texas, 77029, United States

  • Hawthorne Health - Staten Island- Site Number : 8400254

    Staten Island, New York, 10309, United States

  • Hawthorne- Bienstar Lindenwold- Site Number : 8400256

    Lindenwold, New Jersey, 08021, United States

  • Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400072

    Fort Worth, Texas, 76104, United States

  • High Quality Research- Site Number : 8400245

    Miami, Florida, 33184, United States

  • Houston Clinical Research Associates- Site Number : 8400018

    Houston, Texas, 77090, United States

  • Hutchinson Clinic- Site Number : 8400061

    Hutchinson, Kansas, 67502, United States

  • Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400112

    Baytown, Texas, 77521, United States

  • Investigational Site Number : 0360001

    Westmead, New South Wales, 2145, Australia

  • Investigational Site Number : 0360002

    Parkville, Victoria, 3052, Australia

  • Investigational Site Number : 0360003

    Perth, Western Australia, 6008, Australia

  • Investigational Site Number : 0360004

    Brisbane, Queensland, 4101, Australia

  • Investigational Site Number : 0360005

    Southport, Queensland, 4215, Australia

  • Investigational Site Number : 3400001

    San Pedro Sula, Honduras

  • Investigational Site Number : 3400002

    Tegucigalpa, 11101, Honduras

  • Investigational Site Number : 3400003

    Tegucigalpa, 11101, Honduras

  • Investigational Site Number : 4100001

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Investigational Site Number : 4100002

    Anyang-si, Gyeonggi-do, 14068, South Korea

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100005

    Seoul, Seoul-teukbyeolsi, 02841, South Korea

  • Investigational Site Number : 4100006

    Incheon, Incheon-gwangyeoksi, 21565, South Korea

  • Investigational Site Number : 4100007

    Seoul, Seoul-teukbyeolsi, 05030, South Korea

  • Investigational Site Number : 4100008

    Seoul, Seoul-teukbyeolsi, 01830, South Korea

  • Investigational Site Number : 4100009

    Seoul, Seoul-teukbyeolsi, 03312, South Korea

  • Investigational Site Number : 4100010

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Investigational Site Number : 4100011

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • Investigational Site Number : 4100013

    Bucheon-si, Gyeonggi-do, 14584, South Korea

  • Investigational Site Number : 4100014

    Hwaseong-si, Gyeonggi-do, 18450, South Korea

  • Investigational Site Number : 4100015

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100016

    Seoul, Seoul-teukbyeolsi, 08308, South Korea

  • Investigational Site Number : 4100017

    Bupyeong-Gu, Incheon-gwangyeoksi, 21431, South Korea

  • Investigational Site Number : 4100018

    Seoul, Seoul-teukbyeolsi, 07985, South Korea

  • Investigational Site Number : 4100019

    Seoul, Seoul-teukbyeolsi, 01812, South Korea

  • Investigational Site Number : 4100020

    Ansan-si, Gyeonggi-do, 15355, South Korea

  • Investigational Site Number : 4100022

    Seoul, Seoul-teukbyeolsi, 07345, South Korea

  • Investigational Site Number : 4100023

    Busan, Busan, 49241, South Korea

  • Investigational Site Number : 4100024

    Daegu, Daegu, 42601, South Korea

  • Investigational Site Number : 4100025

    Jeonju, Jeollabuk-do, 54907, South Korea

  • Investigational Site Number : 4100026

    Seoul, Seoul-teukbyeolsi, 06591, South Korea

  • Investigational Site Number : 4100027

    Changwon-Si, Gyeongsangnam-do, 51472, South Korea

  • Investigational Site Number : 4100029

    Bucheon-si, Gyeonggi-do, 14647, South Korea

  • Investigational Site Number : 4100030

    Daegu, Daegu, 41944, South Korea

  • Investigational Site Number : 4100031

    Seoul, Seoul-teukbyeolsi, 06273, South Korea

  • Investigational Site Number : 4100034

    Gwangju, Gwangju, 61453, South Korea

  • Investigational Site Number : 6300002

    San Juan, 00918, Puerto Rico

  • Investigational Site Number : 6300003

    Ponce, 00716, Puerto Rico

  • Investigational Site Number : 6300004

    Caguas, 00725, Puerto Rico

  • Investigational Site Number : 6300005

    Trujillo Alto, 00976, Puerto Rico

  • Investigational Site Number : 6300006

    San Juan, 00936, Puerto Rico

  • Investigational Site Number : 6300008

    Guayama, 00786, Puerto Rico

  • Investigational Site Number : 7640004

    Khon Kaen, 40002, Thailand

  • Investigational Site Number : 7640005

    Bangkok, 10700, Thailand

  • Investigational Site Number : 7640007

    Bangkok, 10330, Thailand

  • KUR Research at Columbia MD - 6220 Old Dobbin Lane- Site Number : 8400242

    Columbia, Maryland, 21045, United States

  • La Providence Pediatrics & Family Clinics- Site Number : 8400026

    Houston, Texas, 77071, United States

  • Leavitt Women's Healthcare- Site Number : 8400085

    Idaho Falls, Idaho, 83404, United States

  • LinQ Research, LLC - Rosharon- Site Number : 8400257

    Rosharon, Texas, 77583, United States

  • Matrix Clinical Research - Huntington Park- Site Number : 8400012

    Huntington Park, California, 90255, United States

  • Matrix Clinical Research - Los Angeles- Site Number : 8400013

    Los Angeles, California, 90057, United States

  • Maximos Ob/Gyn- Site Number : 8400056

    League City, Texas, 77573, United States

  • Medical Research Partners - Ammon- Site Number : 8400239

    Ammon, Idaho, 83406, United States

  • Miami Clinical Research Tower- Site Number : 8400189

    Miami, Florida, 33155, United States

  • Michigan Institute of Research- Site Number : 8400207

    Allen Park, Michigan, 48101, United States

  • Monroe Biomedical Research - Monroe- Site Number : 8400225

    Monroe, North Carolina, 28112, United States

  • National Clinical Trials - Tampa- Site Number : 8400229

    Tampa, Florida, 33612, United States

  • Northwest Arkansas Pediatric Clinic- Site Number : 8400030

    Fayetteville, Arkansas, 72703, United States

  • NurtureGen Research- Site Number : 8400205

    Homestead, Florida, 33030, United States

  • Oklahoma State University Center for Health Sciences- Site Number : 8400121

    Tulsa, Oklahoma, 74107, United States

  • Optimal Research Sites- Site Number : 8400232

    Orange City, Florida, 32763, United States

  • PAS Research - Tampa- Site Number : 8400002

    Tampa, Florida, 33613, United States

  • PAS Research- Site Number : 8400123

    Clearwater, Florida, 33756, United States

  • Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259

    Pasadena, California, 91101, United States

  • Pediatric Center - Richmond- Site Number : 8400068

    Richmond, Texas, 77469, United States

  • Prime Global Research- Site Number : 8400246

    The Bronx, New York, 10456, United States

  • Private Practice - Dr. Chinyere N. Awa- Site Number : 8400252

    Houston, Texas, 77057, United States

  • Prohealth Research Center- Site Number : 8400159

    Doral, Florida, 33166, United States

  • Rio Clinical Trials - Canyon View- Site Number : 8400222

    Ogden, Utah, 84404, United States

  • Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400032

    Miami Lakes, Florida, 33014, United States

  • SEC Clinical Research - Pensacola- Site Number : 8400003

    Pensacola, Florida, 32501, United States

  • Snake River Research- Site Number : 8400060

    Idaho Falls, Idaho, 83404, United States

  • South Texas Clinical Research- Site Number : 8400025

    Corpus Christi, Texas, 78413, United States

  • Southland Clinical Research Center- Site Number : 8400243

    Fountain Valley, California, 92708, United States

  • Sun City Clinical Research- Site Number : 8400247

    Glendale, Arizona, 85304, United States

  • Tanner Clinic - Layton Antelope A- Site Number : 8400241

    Layton, Utah, 84041, United States

  • Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400005

    Greenville, South Carolina, 29607, United States

  • University of California Los Angeles Medical Center- Site Number : 8400238

    Los Angeles, California, 90095, United States

  • University of Missouri Hospital- Site Number : 8400244

    Columbia, Missouri, 65212, United States

  • University of New Mexico Health Sciences Center- Site Number : 8400240

    Albuquerque, New Mexico, 87131-0001, United States

  • Vasconcello-Cohen MD Research, LLC- Site Number : 8400248

    Miami, Florida, 33183, United States

  • Vector Clinical Trials- Site Number : 8400249

    Las Vegas, Nevada, 89128, United States

  • Velocity Clinical Research - Washington DC- Site Number : 8400049

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

  • Ventavia Research Group - Houston - North Loop West- Site Number : 8400093

    Houston, Texas, 77008, United States

  • Wasatch Pedicatrics- Site Number : 8400153

    Murray, Utah, 84107, United States

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