Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06824194

PHASE3

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.

Official title: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2 Arm Study to Investigate the Safety of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

Key Details

Gender

All

Age Range

42 Days - 89 Days

Study Type

INTERVENTIONAL

Enrollment

2320

Start Date

2025-02-18

Completion Date

2027-05-12

Last Updated

2026-03-03

Healthy Volunteers

Yes

Conditions

Pneumococcal Immunization

Interventions

BIOLOGICAL

PCV21 vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

BIOLOGICAL

Prevnar 20 vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

BIOLOGICAL

M-M-R II vaccine

Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular

BIOLOGICAL

Rotarix

Pharmaceutical form:Solution-Route of administration:Oral

BIOLOGICAL

RotaTeq

Pharmaceutical form:Solution-Route of administration:Oral

BIOLOGICAL

Vaxelis vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

BIOLOGICAL

Varivax

Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular

BIOLOGICAL

Priorix

Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous

BIOLOGICAL

VAQTA

Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular

BIOLOGICAL

Havrix

Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular

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 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 substances * Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legal 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. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * Receipt of any non-US Food and Drug Administration (FDA) approved vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any non-US FDA approved vaccine in the 4 weeks following the study intervention administration, including monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations. * Receipt of any Bacillus of Calmette and Guerin (BCG) vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period * Previous vaccination against S. 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.

Locations (134)

Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013

Birmingham, Alabama, United States

University of Alabama at Birmingham- Site Number : 8400130

Birmingham, Alabama, United States

Lakeview Clinical Research- Site Number : 8400054

Guntersville, Alabama, United States

Midway Medical Clinic- Site Number : 8400091

Oneonta, Alabama, United States

Noble Clinical Research- Site Number : 8400121

Tucson, Arizona, United States

The Children's Clinic- Site Number : 8400079

Jonesboro, Arkansas, United States

Helios CR, Inc. - Little Rock- Site Number : 8400090

Sherwood, Arkansas, United States

Helping Hands Healthcare Group - Fullerton- Site Number : 8400063

Fullerton, California, United States

Advanced Investigative Medicine- Site Number : 8400055

Hawthorne, California, United States

Century Research Institute- Site Number : 8400118

Huntington Park, California, United States

Matrix Clinical Research - Huntington Park- Site Number : 8400117

Huntington Park, California, United States

Matrix Clinical Research - Los Angeles- Site Number : 8400026

Los Angeles, California, United States

Matrix Clinical Research - Los Angeles- Site Number : 8400123

Los Angeles, California, United States

Alliance Research Institute - Lynwood- Site Number : 8400099

Lynwood, California, United States

Madera Family Medical Group- Site Number : 8400011

Madera, California, United States

FOMAT-Golden Valley Health Centers- Site Number : 8400084

Merced, California, United States

Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400072

Palo Alto, California, United States

Center for Clinical Trials - Paramount- Site Number : 8400100

Paramount, California, United States

Integrated Clinical Research LLC- Site Number : 8400027

Sherman Oaks, California, United States

Emanate Health - Queen of the Valley Hospital- Site Number : 8400105

West Covina, California, United States

All In One Clinic- Site Number : 8400127

Whittier, California, United States

Amicis Research Center-Winnetka- Site Number : 8400128

Winnetka, California, United States

Emerson Clinical Research Institute - Washington - Connecticut Avenue- Site Number : 8400102

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

D&H Doral Research Center- Site Number : 8400095

Doral, Florida, United States

Dolphin Medical Research, LLC- Site Number : 8400120

Doral, Florida, United States

Nextlevel Research Center- Site Number : 8400065

Doral, Florida, United States

CuraCare- Site Number : 8400125

Kendall, Florida, United States

PAS RESEARCH-Lutz- Site Number : 8400103

Lutz, Florida, United States

Abba Medical Research- Site Number : 8400064

Miami, Florida, United States

D&H National Research Center- Site Number : 8400085

North Miami, Florida, United States

Alfa Medical Research LLC- Site Number : 8400111

Pembroke Pines, Florida, United States

PAS Research - Tampa- Site Number : 8400113

Tampa, Florida, United States

Morehouse School of Medicine - Atlanta- Site Number : 8400093

Atlanta, Georgia, United States

Primary Pediatrics of Macon at Velocity Clinical Research- Site Number : 8400004

Macon, Georgia, United States

CenExel - iResearch - Savannah- Site Number : 8400057

Savannah, Georgia, United States

Bingham Memorial Hospital - Blackfoot- Site Number : 8400114

Blackfoot, Idaho, United States

Elite Clinical Trials - Blackfoot- Site Number : 8400017

Blackfoot, Idaho, United States

Clinical Research Prime- Site Number : 8400022

Idaho Falls, Idaho, United States

Eagle Clinical Research- Site Number : 8400087

Chicago, Illinois, United States

University of Chicago Medical Center- Site Number : 8400062

Chicago, Illinois, United States

MidValley Research - Moline- Site Number : 8400096

Moline, Illinois, United States

South Bend Clinic - Main Campus- Site Number : 8400023

South Bend, Indiana, United States

Integrated Clinical Trial Services- Site Number : 8400059

West Des Moines, Iowa, United States

Kentucky Pediatric Research- Site Number : 8400014

Bardstown, Kentucky, United States

University of Kentucky Chandler Medical Center- Site Number : 8400034

Lexington, Kentucky, United States

Novak Center For Children's Health- Site Number : 8400073

Louisville, Kentucky, United States

Bluegrass Clinical Research - Louisville - Blankenbaker Parkway- Site Number : 8400056

Louisville, Kentucky, United States

Velocity Clinical Research - Lafayette- Site Number : 8400046

Lafayette, Louisiana, United States

NOLA Research Works- Site Number : 8400035

New Orleans, Louisiana, United States

The Pediatric Center- Site Number : 8400075

Columbia, Maryland, United States

The Pediatric Center of Frederick- Site Number : 8400074

Frederick, Maryland, United States

Virgo Carter Pediatrics- Site Number : 8400001

Silver Spring, Maryland, United States

Michigan Institute of Research- Site Number : 8400131

Allen Park, Michigan, United States

Vida Clinical Studies - Dearborn- Site Number : 8400094

Dearborn, Michigan, United States

Clinical Research Institute - Minneapolis- Site Number : 8400002

Minneapolis, Minnesota, United States

Jefferson City Medical Group- Site Number : 8400129

Jefferson City, Missouri, United States

Midwest Children's Health Research Institute - Lincoln - Salt Creek Circle- Site Number : 8400019