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

Status: Recruiting
Location: See all (9) 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. 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 two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are: \- infants who are about 2 months of age About 2400 infants will be assigned by chance to one of the two groups to receive 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. Infants will take part in this study for about 16 to 19 months (about 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 3 months
Healthy Volunteers: t
View:

• Infants who are about 2 months of age

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

Locations
United States
Florida
Starz Pediatrics
NOT_YET_RECRUITING
Estero
Georgia
Rophe Adult and Pediatric Medicine/SKYCRNG
NOT_YET_RECRUITING
Union City
Idaho
Rosemark Women Care Specialists
NOT_YET_RECRUITING
Idaho Falls
Kentucky
Kentucky Pediatric/ Adult Research
NOT_YET_RECRUITING
Bardstown
Massachusetts
Pediatric Associates of Fall River
NOT_YET_RECRUITING
Fall River
Ohio
Senders Pediatrics
RECRUITING
South Euclid
Oregon
Cyn3rgy Research Corporation
NOT_YET_RECRUITING
Gresham
South Carolina
Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
RECRUITING
Simpsonville
Virginia
Pediatric Research of Charlottesville, LLC.
RECRUITING
Gordonsville
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-05-04
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 2400
Treatments
Experimental: PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
Active_comparator: 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