Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
- 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 children 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. 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 children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae This study is seeking participants who: * Are children aged 15 months to 18 years. * May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past. The study will be conducted in the United States, Puerto Rico, and other countries. Participants will be assigned to 1 of 3 groups based on age: Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants) Within each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC. Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up). At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.
- Short title
- Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
- Official title
- A PHASE 3, RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CATCH-UP VACCINATION REGIMEN OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN AND ADOLESCENTS
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-12-02
- First posted
- 2026-06-22
- Registry last updated
- 2026-07-09
- Primary completion date
- 2027-12-02
- Start date
- 2026-06-15
- Participants
- 1,200
- Participant count basis
- Estimated
- Planned participants
- 1,200
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Pfizer
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07660198
- ClinicalTrials.gov ID
- NCT07660198
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Triple masking
- Masked roles
- Participants, Care providers, Investigators
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Timeframe: Within 7 days after Vaccination
Percentage of Participants With Systemic Events Within 7 Days after Vaccination
Timeframe: Within 7 days after Vaccination
Percentage of Participants With Adverse Events (AEs)
Timeframe: From Vaccination to 1 month after Vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
Timeframe: From Vaccination to 6 months after Vaccination
GMCs of serotype-specific IgG concentrations
Timeframe: 1 month after vaccination
GMTs of serotype-specific OPA titers
Timeframe: 1 month after vaccination
Percentage of participants with predefined serotype-specific IgG concentrations
Timeframe: 1 month after vaccination
IgG GMFRs
Timeframe: 1 month after vaccination
Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers
Timeframe: before to 1 month after vaccination
OPA GMFRs
Timeframe: before to 1 month after vaccination
- Sex
- All
- Age groups
- Children
- Minimum age
- 15 Months
- Maximum age
- 17 Years
- Healthy volunteers
- Yes
Cohort 1 (Participants ≥15 Months to <2 Years of Age) Healthy toddlers and children ≥15 months to <2 years of age with documentation of prior receipt of PCV.
Cohort 2 (Participants ≥2 Years to <5 Years of Age) Healthy toddlers and children ≥2 years to <5 years of age with documentation of prior receipt of PCV if applicable.
Cohort 3 (Participants ≥5 Years to <18 Years of Age) Healthy children ≥5 years to <18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.
All Cohorts (Participants ≥15 Months to <18 Years of Age)
Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric AssociatesBirmingham, United StatesRecruiting
- Apex Research GroupFair Oaks, United StatesRecruiting
- Orange County Research InstituteOntario, United StatesRecruiting
- Riveldi and AssociatesMiami Lakes, United StatesNot yet recruiting
- Indago Research & Health Center, IncMiami Lakes, United StatesRecruiting
- Medical Research PartnersAmmon, United StatesNot yet recruiting
- Bingham Memorial HospitalBlackfoot, United StatesRecruiting
- ASR, LLCBoise, United StatesRecruiting
- Kentucky Pediatric/ Adult ResearchBardstown, United StatesRecruiting
- AvacareCovington, United StatesNot yet recruiting
- Velocity Clinical Research, LafayetteLafayette, 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 StatesRecruiting
- Michigan Center of Medical ResearchBingham Farms, United StatesRecruiting
- Clinical Research Institute, Inc.Minneapolis, United StatesRecruiting
- Midwest Children's Health Research InstituteLincoln, United StatesRecruiting
- Midwest Children's Health Research InstituteLincoln, United StatesRecruiting
- Midwest Children's Health Research InstituteLincoln, United StatesRecruiting
- Midwest Children's Health Research InstituteLincoln, United StatesRecruiting
- Child Health Care AssociatesEast Syracuse, United StatesNot yet recruiting
- Corning Center for Clinical ResearchHorseheads, United StatesRecruiting
- Pediatric Associates of Mt. CarmelCincinnati, United StatesNot yet recruiting
And 19 more, listed on the interactive page.
- Related resource (pmiform.com)
- 2025
- 2025-523445-10-00