Otitis 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 (73) 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
Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
RECRUITING
Birmingham
Arkansas
Northwest Arkansas Pediatric Clinic
NOT_YET_RECRUITING
Fayetteville
The Children's Clinic of Jonesboro, P.A.
NOT_YET_RECRUITING
Jonesboro
California
San Gabriel Woman's Health
NOT_YET_RECRUITING
Arcadia
Family Medical Clinic
NOT_YET_RECRUITING
El Monte
Clinical Research of Central California
RECRUITING
Fresno
SeraCollection Research Services, LLC
NOT_YET_RECRUITING
Montebello
Stanford University Medical Center CTRU - 800 Welch Road
NOT_YET_RECRUITING
Palo Alto
Florida
C & R Research Services USA
RECRUITING
Homestead
Bioresearch Partner
NOT_YET_RECRUITING
Miami
Dade Research Center
NOT_YET_RECRUITING
Miami
Florida Pharmaceutical Research and Associates, Inc.
RECRUITING
Miami
Gold Coast Health Research Center, LLC
NOT_YET_RECRUITING
Miami
Vasconcello-Cohen MD Research, LLC.
NOT_YET_RECRUITING
Miami
Riveldi and Associates
NOT_YET_RECRUITING
Miami Lakes
Eminent Clinical Research and Associates
RECRUITING
North Lauderdale
Cordova Research Institute LLC
NOT_YET_RECRUITING
Sweetwater
Georgia
Altruistic Clinical Research Global
RECRUITING
Norcross
Iowa
The Iowa Clinic.
NOT_YET_RECRUITING
Ankeny
Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
NOT_YET_RECRUITING
West Des Moines
Idaho
Medical Research Partners
NOT_YET_RECRUITING
Ammon
ASR, LLC
NOT_YET_RECRUITING
Boise
Illinois
MidValley Research, Inc
NOT_YET_RECRUITING
Moline
Kansas
Integrity Clinical Network, LLC
NOT_YET_RECRUITING
Derby
Louisiana
ACC Pediatric Research
RECRUITING
Haughton
Maryland
Kur Research, LLC
NOT_YET_RECRUITING
Columbia
Michigan
Michigan Institute of Research
NOT_YET_RECRUITING
Allen Park
Michigan Center of Medical Research
NOT_YET_RECRUITING
Bingham Farms
North Carolina
Duke Vaccine and Trials Unit
RECRUITING
Durham
Durham Pediatrics at North Duke Street
RECRUITING
Durham
Wilmington Health
NOT_YET_RECRUITING
Wilmington
Nebraska
Velocity Clinical Research, Grand Island
NOT_YET_RECRUITING
Grand Island
Midwest Children's Health Research Institute
RECRUITING
Lincoln
Midwest Children's Health Research Institute
NOT_YET_RECRUITING
Lincoln
Midwest Children's Health Research Institute
NOT_YET_RECRUITING
Lincoln
Midwest Children's Health Research Institute
RECRUITING
Lincoln
New York
University of Rochester Medical Center
NOT_YET_RECRUITING
Rochester
Ohio
Pediatric Associates of Mt. Carmel
NOT_YET_RECRUITING
Cincinnati
PriMED Clinical Research
NOT_YET_RECRUITING
Dayton
Senders Pediatrics
RECRUITING
South Euclid
Pennsylvania
Allegheny Health and Wellness Pavilion
NOT_YET_RECRUITING
Erie
South Carolina
Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
RECRUITING
Simpsonville
Tennessee
Pediatric Clinical Trials of Tennessee, LLC
NOT_YET_RECRUITING
Tullahoma
Texas
Proactive RGV
NOT_YET_RECRUITING
Brownsville
Proactive Clinical Research LLC
NOT_YET_RECRUITING
Edinburg
Proactive El Paso,LLC
NOT_YET_RECRUITING
El Paso
Houston Clinical Research Associates
NOT_YET_RECRUITING
Houston
Kool Kids Pediatrics
NOT_YET_RECRUITING
Houston
Mercury Clinical Research - Pediatric Associates
RECRUITING
Houston
Mercury Clinical Research - Sunrise Pediatrics
RECRUITING
Houston
Mercury Clinical Research (Administrative Office)
RECRUITING
Houston
Neutra Life Sciences
NOT_YET_RECRUITING
Houston
SMS Clinical Research LLC
RECRUITING
Mesquite
Pediatric Center- Neutra Life Sciences
NOT_YET_RECRUITING
Richmond
Utah
AMR Clinical
NOT_YET_RECRUITING
Provo
AMR Clinical
NOT_YET_RECRUITING
Syracuse
Virginia
Clinical Research Partners, LLC
RECRUITING
Richmond
Tekton Research, LLC.
NOT_YET_RECRUITING
Richmond
Other Locations
Japan
Fukui Aiiku Hospital
NOT_YET_RECRUITING
Fukui
Shindo children's clinic
NOT_YET_RECRUITING
Fukuoka
Yokoyama Children'S Clinic
NOT_YET_RECRUITING
Kasuga
Kose Children Clinic
NOT_YET_RECRUITING
Kofu
Kubota Children's Clinic
NOT_YET_RECRUITING
Osaka
Ohigesenseino Kodomo Clinic
NOT_YET_RECRUITING
Sapporo
Futaba Clinic
NOT_YET_RECRUITING
Shinjuku-ku
Puerto Rico
Clinical Research Investigator Group
NOT_YET_RECRUITING
Bayamón
Caguas Clinical Research
NOT_YET_RECRUITING
Caguas
San Juan Bautista School of Medicine - Clinical Research Unit
NOT_YET_RECRUITING
Caguas
Clinical Research Puerto Rico
NOT_YET_RECRUITING
Guayama
BRCR Global Puerto Rico
NOT_YET_RECRUITING
Ponce
Ponce Medical School Foundation Inc./ CAIMED Center
NOT_YET_RECRUITING
Ponce
BRCR Global Puerto Rico
NOT_YET_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