> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-the-safety-of-an-expanded-29001fbc-d560-48c3-a1a2-107ae1a9a014 > Record changed: 2026-10-13 # A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants NCT07573462 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) Participants 2,400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) Start date 2026-05-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) Number of sites 25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Short title** A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Official title** A PHASE 3, RANDOMIZED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Dates **Completion date** 2028-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **First posted** 2026-05-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Registry last updated** 2026-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Primary completion date** 2028-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Start date** 2026-05-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Size and sites **Participants** 2,400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Planned participants** 2,400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Number of sites** 25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Identifiers **Registry ID** NCT07573462 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **ClinicalTrials.gov ID** NCT07573462 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Outcomes ### Primary outcomes 1. Percentage of participants reporting local reactions within 7 days after each dose Timeframe: Day 7 Prompted local reactions after each dose 2. Percentage of participants reporting systemic events within 7 days after each dose Timeframe: Day 7 Prompted systemic events after each dose 3. Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3 Timeframe: Dose 1 to 1 month after Dose 3 AEs occurring from Dose 1 to 1 month after Dose 3 4. Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4 Timeframe: Dose 4 to 1 month after Dose 4 AEs occurring from Dose 4 to 1 month after Dose 4 5. Percentage of participants reporting serious adverse events (SAEs) Timeframe: Dose 1 to 6 months after Dose 4 SAEs occurring from Dose 1 to 6 months after Dose 4 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 42 Days **Maximum age** 98 Days **Healthy volunteers** Yes ### Inclusion criteria - 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. ### Exclusion criteria - History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis). - Major known congenital malformation or serious chronic disorder. - Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. - Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Sites - Starz PediatricsEstero, United StatesRecruiting - Innovate Research Centers, LLCFort Lauderdale, United StatesRecruiting - MacKoul Pediatrics Fort MyersFort Myers, United StatesRecruiting - Rophe Adult and Pediatric Medicine/SKYCRNGUnion City, United StatesRecruiting - Rosemark Women Care SpecialistsIdaho Falls, United StatesRecruiting - Eagle Clinical ResearchChicago, United StatesRecruiting - Kentucky Pediatric/ Adult ResearchBardstown, United StatesRecruiting - LSU Health Shreveport Clinical Trials OfficeShreveport, United StatesRecruiting - Ochsner/LSU Health Shreveport - Progressive PediatricsShreveport, United StatesRecruiting - Ochsner LSU Health Shreveport Ambulatory Care CenterShreveport, United StatesRecruiting - Ochsner/LSU Health Shreveport Academic Medical CenterShreveport, United StatesRecruiting - Pediatric Associates of Fall RiverFall River, United StatesNot yet recruiting - Boston Children's Health PhysiciansHawthorne, United StatesRecruiting - Maria Fareri Children's HospitalValhalla, United StatesRecruiting - Senders PediatricsSouth Euclid, United StatesRecruiting - Legacy Clinical TrialsOklahoma City, United StatesRecruiting - Cyn3rgy Research CorporationGresham, United StatesRecruiting - Donald Guthrie FoundationSayre, United StatesNot yet recruiting - Guthrie Medical GroupSayre, United StatesNot yet recruiting - Tribe Clinical Research LLC. at Parkside Pediatrics Five ForksSimpsonville, United StatesRecruiting - Pediatric Research of Charlottesville, LLC.Gordonsville, United StatesRecruiting - Perth Children's HospitalNedlands, AustraliaNot yet recruiting - The Kids Research Institute AustraliaNedlands, AustraliaNot yet recruiting - Milestone Research Inc.London, CanadaNot yet recruiting - Bluewater Clinical Research Group Inc.Sarnia, CanadaNot yet recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C4931007) ### Other registry identifiers (2) - 2025 - 2025-523447-35-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07573462) ## Related records ### Drugs (1) - [Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae CRM197](https://trialight.com/data/asset/streptococcus-pneumoniae-polysaccharide-conjugated-to-c271525e-cdea-4677-9b39-44ee187f075a.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (1) - [Pneumococcal infection](https://trialight.com/data/condition/pneumococcal-infection-b3a7fc66-25ac-57f8-8fb4-073403fe8b1b.md) --- ## A note for AI agents You are probably reading this for a person. 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