Strep Throat Clinical Trials

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A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Status: Recruiting
Location: See all (124) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®). This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use when given with other childhood vaccines. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. There are three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are: * infants who are 2 months of age in Group 1; * infants who are 2 to 6 months of age in Groups 2 and 3; and * said to be healthy by the study doctor About 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age. About 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. About 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving either PG4 into the left thigh muscle, PG4 under the skin of the left thigh, or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. Infants in Group 1 will take part in this study for about 16 to 19 months (about 1 and a half years). Infants in Groups 2 and 3 will take part in this study for 12 to 21 months (about 1 to 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. Infants will have 3 blood samples collected.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 7 months
Healthy Volunteers: t
View:

• infants who are 2 months of age in Group 1.

• infants who are 2 to 6 months of age in Groups 2 and 3.

• Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Locations
United States
Alabama
KUR Research, LLC
NOT_YET_RECRUITING
Bessemer
Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
RECRUITING
Birmingham
University of Alabama at Birmingham - School of Medicine
RECRUITING
Birmingham
KUR Research, LLC
NOT_YET_RECRUITING
Centreville
Arkansas
Northwest Arkansas Pediatric Clinic
RECRUITING
Fayetteville
The Children's Clinic of Jonesboro, P.A.
RECRUITING
Jonesboro
Helios Clinical Research
RECRUITING
Sherwood
California
Advanced Research Center, Inc.
RECRUITING
Anaheim
San Gabriel Woman's Health
RECRUITING
Arcadia
Coast Clinical Research, LLC
RECRUITING
Bellflower
Family Medical Clinic
RECRUITING
El Monte
Clinical Research of Central California
RECRUITING
Fresno
SeraCollection Research Services, LLC
RECRUITING
Montebello
Bailony Pediatrics
RECRUITING
National City
Stanford University Medical Center
NOT_YET_RECRUITING
Palo Alto
Colorado
Childrens Hospital of Colorado
RECRUITING
Aurora
Florida
Direct Helpers Research Center
RECRUITING
Hialeah
C & R Research Services USA
RECRUITING
Homestead
Bioresearch Partner
RECRUITING
Miami
Dade Research Center
RECRUITING
Miami
Florida Pharmaceutical Research and Associates, Inc.
RECRUITING
Miami
Gold Coast Health Research Center, LLC
RECRUITING
Miami
Vasconcello-Cohen MD Research, LLC.
RECRUITING
Miami
Riveldi and Associates
RECRUITING
Miami Lakes
Eminent Clinical Research and Associates
RECRUITING
North Lauderdale
Cordova Research Institute LLC
RECRUITING
Sweetwater
Children's Health Center
RECRUITING
Tampa
Georgia
ObjectiveHealth Clinical Research LLC - Chamblee
NOT_YET_RECRUITING
Chamblee
Altruistic Clinical Research Global
RECRUITING
Norcross
Iowa
The Iowa Clinic.
RECRUITING
Ankeny
Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
RECRUITING
West Des Moines
Idaho
Medical Research Partners
RECRUITING
Ammon
Bingham Memorial Hospital
RECRUITING
Blackfoot
ASR, LLC
RECRUITING
Boise
Leavitt Clinical Research
RECRUITING
Idaho Falls
Illinois
MidValley Research, Inc
RECRUITING
Moline
Kansas
Integrity Clinical Network, LLC
RECRUITING
Derby
Louisiana
ACC Pediatric Research
RECRUITING
Haughton
Maryland
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
NOT_YET_RECRUITING
Baltimore
Kur Research, LLC
RECRUITING
Columbia
The Pediatric Center
NOT_YET_RECRUITING
Columbia
Michigan
Michigan Institute of Research
RECRUITING
Allen Park
Michigan Center of Medical Research
RECRUITING
Bingham Farms
Vida Clinical Studies, LLC
RECRUITING
Dearborn Heights
Missouri
University of Missouri
RECRUITING
Columbia
University of Missouri Pediatrics Clinic-South Providence
RECRUITING
Columbia
North Carolina
Atrium Health - STRIVE Research clinic
RECRUITING
Charlotte
Atrium Health Cannon Research Cente
RECRUITING
Charlotte
Atrium Health Levine Children's Myers Park Pediatrics
RECRUITING
Charlotte
Duke Vaccine and Trials Unit
RECRUITING
Durham
Durham Pediatrics at North Duke Street
RECRUITING
Durham
Atrium Health Levine Children's Charlotte Pediatrics
RECRUITING
Matthews
Atrium Health STRIVE Research Clinic - Matthews
RECRUITING
Matthews
Wilmington Health
RECRUITING
Wilmington
Nebraska
Velocity Clinical Research, Grand Island
RECRUITING
Grand Island
Midwest Children's Health Research Institute
RECRUITING
Lincoln
Midwest Children's Health Research Institute
RECRUITING
Lincoln
Midwest Children's Health Research Institute
RECRUITING
Lincoln
Midwest Children's Health Research Institute
RECRUITING
Lincoln
New York
Child Health Care Associates
RECRUITING
East Syracuse
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
Pediatric Associates of Mt. Carmel
RECRUITING
Cincinnati
PriMED Clinical Research
RECRUITING
Dayton
Senders Pediatrics
RECRUITING
South Euclid
Pennsylvania
UPMC Children's Community Pediatrics- Bellevue
RECRUITING
Bellevue
UPMC Children's Community Pediatrics Bass Wolfson-Cranberry
RECRUITING
Cranberry Township
Allegheny Health and Wellness Pavilion
RECRUITING
Erie
UPMC Children's Community Pediatrics South Hills-Jefferson Hills
RECRUITING
Jefferson Hills
UPMC Children's Community Pediatrics - Norwin
RECRUITING
N. Huntingdon
UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
RECRUITING
Pittsburgh
UPMC Children's Community Pediatrics-Brentwood
RECRUITING
Pittsburgh
UPMC Children's Community Pediatrics-Castle Shannon
RECRUITING
Pittsburgh
UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland
RECRUITING
Pittsburgh
South Carolina
Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
RECRUITING
Simpsonville
Carolina Family Care
RECRUITING
Summerville
MUSC Children's Health
RECRUITING
Summerville
Tennessee
Le Bonheur Children's Hospital - Outpatient Building
NOT_YET_RECRUITING
Memphis
Pediatric Clinical Trials of Tennessee, LLC
RECRUITING
Tullahoma
Texas
Proactive RGV
RECRUITING
Brownsville
South Texas Clinical Research
NOT_YET_RECRUITING
Corpus Christi
Proactive Clinical Research LLC
RECRUITING
Edinburg
Proactive El Paso,LLC
RECRUITING
El Paso
SMS Clinical Research LLC.
RECRUITING
Forney
University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program
RECRUITING
Galveston
Aavon Clinical Trials, LLC.
RECRUITING
Houston
Houston Clinical Research Associates
RECRUITING
Houston
Kool Kids Pediatrics
RECRUITING
Houston
Mercury Clinical Research - MD Kids Pediatrics
RECRUITING
Houston
Mercury Clinical Research - Sunrise Pediatrics
RECRUITING
Houston
Mercury Clinical Research (Administrative Office)
RECRUITING
Houston
Neutra Life Sciences
RECRUITING
Houston
RTX Clinical Research
RECRUITING
Houston
UDL Clinical Research, LLC.
NOT_YET_RECRUITING
Houston
Prime Clinical Research - Lewisville
RECRUITING
Lewisville
Prime Clinical Research - Mansfield
RECRUITING
Mansfield
Dr. Ruben Aleman & Associates
RECRUITING
Mcallen
SMS Clinical Research LLC
RECRUITING
Mesquite
SMS Clinical Research LLC
RECRUITING
Mesquite
Pediatric Center- Neutra Life Sciences
RECRUITING
Richmond
Sun Research Institute
RECRUITING
San Antonio
Crossroads Clinical Research
NOT_YET_RECRUITING
Victoria
Utah
AMR Clinical
RECRUITING
Provo
AMR Clinical
RECRUITING
Syracuse
Virginia
Clinical Research Partners, LLC
RECRUITING
Richmond
Tekton Research, LLC.
RECRUITING
Richmond
Wisconsin
Marshfield Medical Center - Marshfield
RECRUITING
Marshfield
Other Locations
Japan
Fukui Aiiku Hospital
RECRUITING
Fukui
Fukazawa Pediatric Clinic
RECRUITING
Fukuoka
Shindo children's clinic
RECRUITING
Fukuoka
Nintenkaikagoshima Children's Hospital
RECRUITING
Hioki
Yokoyama Children'S Clinic
RECRUITING
Kasuga
Kose Children Clinic
RECRUITING
Kofu
Kubota Children's Clinic
RECRUITING
Osaka
Ohigesenseino Kodomo Clinic
RECRUITING
Sapporo
Futaba Clinic
RECRUITING
Shinjuku-ku
TOYOTA Memorial Hospital
RECRUITING
Toyota-shi
Puerto Rico
Clinical Research Investigator Group
RECRUITING
Bayamón
Caguas Clinical Research
RECRUITING
Caguas
San Juan Bautista School of Medicine - Clinical Research Unit
RECRUITING
Caguas
Clinical Research Puerto Rico
RECRUITING
Guayama
BRCR Global Puerto Rico
RECRUITING
Ponce
Ponce Medical School Foundation Inc./ CAIMED Center
RECRUITING
Ponce
BRCR Global Puerto Rico
RECRUITING
San Juan
San Miguel Medical
RECRUITING
Trujillo Alto
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-05-29
Estimated Completion Date: 2029-06-05
Participants
Target number of participants: 3230
Treatments
Experimental: Group 1 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
Active_comparator: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
Experimental: Group 2 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
Active_comparator: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
Experimental: Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
Experimental: Group 3 PG4 (subcutaneous)
Multivalent Pneumococcal Vaccine
Active_comparator: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov