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ACTIVE NOT RECRUITING

NCT06736041

PHASE3

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Sponsor: Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines 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 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints. 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 and Immunogenicity 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

1714

Start Date

2024-12-18

Completion Date

2027-05-17

Last Updated

2026-02-18

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

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

Hexaxim Vaccine

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 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.

Locations (112)

Sun City Clinical Research- Site Number : 8400247

Glendale, Arizona, United States

Eclipse Clinical Research- Site Number : 8400029

Tucson, Arizona, United States

Northwest Arkansas Pediatric Clinic- Site Number : 8400030

Fayetteville, Arkansas, United States

Southland Clinical Research Center- Site Number : 8400243

Fountain Valley, California, United States

Century Research Institute- Site Number : 8400065

Huntington Park, California, United States

Matrix Clinical Research - Huntington Park- Site Number : 8400012

Huntington Park, California, United States

Matrix Clinical Research - Los Angeles- Site Number : 8400013

Los Angeles, California, United States

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

Los Angeles, California, United States

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

Pasadena, California, United States

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

Ventura, California, United States

Velocity Clinical Research - Washington DC- Site Number : 8400049

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

PAS Research- Site Number : 8400123

Clearwater, Florida, United States

Prohealth Research Center- Site Number : 8400159

Doral, Florida, United States

NurtureGen Research- Site Number : 8400205

Homestead, Florida, United States

EMDA Clinical Research- Site Number : 8400237

Miami, Florida, United States

Dade Research Center- Site Number : 8400007

Miami, Florida, United States

Acevedo Clinical Research Associates- Site Number : 8400089

Miami, Florida, United States

Miami Clinical Research Tower- Site Number : 8400189

Miami, Florida, United States

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

Miami, Florida, United States

Bio-Medical Research- Site Number : 8400147

Miami, Florida, United States

High Quality Research- Site Number : 8400245

Miami, Florida, United States

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

Miami Lakes, Florida, United States

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

Miami Lakes, Florida, United States

Optimal Research Sites- Site Number : 8400232

Orange City, Florida, United States

SEC Clinical Research - Pensacola- Site Number : 8400003

Pensacola, Florida, United States

National Clinical Trials - Tampa- Site Number : 8400229

Tampa, Florida, United States

PAS Research - Tampa- Site Number : 8400002

Tampa, Florida, United States

Medical Research Partners - Ammon- Site Number : 8400239

Ammon, Idaho, United States

Bingham Memorial Hospital - Blackfoot- Site Number : 8400084

Blackfoot, Idaho, United States

Leavitt Women's Healthcare- Site Number : 8400085

Idaho Falls, Idaho, United States

Snake River Research- Site Number : 8400060

Idaho Falls, Idaho, United States

Clinical Research Prime Rexburg- Site Number : 8400250

Rexburg, Idaho, United States

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

El Dorado, Kansas, United States

Hutchinson Clinic- Site Number : 8400061

Hutchinson, Kansas, United States

Cotton O'Neil Pediatrics- Site Number : 8400009

Topeka, Kansas, United States

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

Columbia, Maryland, United States

Michigan Institute of Research- Site Number : 8400207

Allen Park, Michigan, United States

University of Missouri Hospital- Site Number : 8400244

Columbia, Missouri, United States

Vector Clinical Trials- Site Number : 8400249

Las Vegas, Nevada, United States

Hawthorne- Bienstar Lindenwold- Site Number : 8400256

Lindenwold, New Jersey, United States

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

Albuquerque, New Mexico, United States

Hawthorne Health - Staten Island- Site Number : 8400254

Staten Island, New York, United States

Prime Global Research- Site Number : 8400246

The Bronx, New York, United States

Monroe Biomedical Research - Monroe- Site Number : 8400225

Monroe, North Carolina, United States

Dayton Clinical Research- Site Number : 8400087

Dayton, Ohio, United States

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

Tulsa, Oklahoma, United States

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

Erie, Pennsylvania, United States

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

Greenville, South Carolina, United States

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

North Charleston, South Carolina, United States

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

Baytown, Texas, United States

South Texas Clinical Research- Site Number : 8400025

Corpus Christi, Texas, United States

FamilyHealthWatch - KeyPoint Clinical Research- Site Number : 8400173

Dallas, Texas, United States

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

Fort Worth, Texas, United States

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

Houston, Texas, United States

Gonzalez Family & Occupational Medicine- Site Number : 8400035

Houston, Texas, United States

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

Houston, Texas, United States

La Providence Pediatrics & Family Clinics- Site Number : 8400026

Houston, Texas, United States

Houston Clinical Research Associates- Site Number : 8400018

Houston, Texas, United States

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

Katy, Texas, United States

Maximos Ob/Gyn- Site Number : 8400056

League City, Texas, United States

Pediatric Center - Richmond- Site Number : 8400068

Richmond, Texas, United States

LinQ Research, LLC - Rosharon- Site Number : 8400257

Rosharon, Texas, United States

Tanner Clinic - Layton Antelope A- Site Number : 8400241

Layton, Utah, United States

Wasatch Pedicatrics- Site Number : 8400153

Murray, Utah, United States

Rio Clinical Trials - Canyon View- Site Number : 8400222

Ogden, Utah, United States

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

Richmond, Virginia, United States

Investigational Site Number : 0360002

Goyang-Si, Gyeonggi-do, Australia

Investigational Site Number : 0360001

Westmead, New South Wales, Australia

Investigational Site Number : 0360004

Brisbane, Queensland, Australia

Investigational Site Number : 0360005

Southport, Queensland, Australia

Investigational Site Number : 0360003

Perth, Western Australia, Australia

Investigational Site Number : 3400001

San Pedro Sula, Honduras

Investigational Site Number : 3400002

Tegucigalpa, Honduras

Investigational Site Number : 3400003

Tegucigalpa, Honduras

Investigational Site Number : 6300004

Caguas, Puerto Rico

Investigational Site Number : 6300008

Guayama, Puerto Rico

Investigational Site Number : 6300003

Ponce, Puerto Rico

Investigational Site Number : 6300002

San Juan, Puerto Rico

Investigational Site Number : 6300006

San Juan, Puerto Rico

Investigational Site Number : 6300005

Trujillo Alto, Puerto Rico

Investigational Site Number : 4100023

Busan, Busan, South Korea

Investigational Site Number : 4100030

Daegu, Daegu, South Korea

Investigational Site Number : 4100024

Daegu, Daegu, South Korea

Investigational Site Number : 4100034

Gwangju, Gwangju, South Korea

Investigational Site Number : 4100020

Ansan-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100002

Anyang-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100013

Bucheon-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100029

Bucheon-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100014

Hwaseong-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100011

Seongnam-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100001

Seongnam-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100027

Changwon-Si, Gyeongsangnam-do, South Korea

Investigational Site Number : 4100010

Yangsan, Gyeongsangnam-do, South Korea

Investigational Site Number : 4100017

Bupyeong-Gu, Incheon-gwangyeoksi, South Korea

Investigational Site Number : 4100006

Incheon, Incheon-gwangyeoksi, South Korea

Investigational Site Number : 4100025

Jeonju, Jeollabuk-do, South Korea

Investigational Site Number : 4100019