A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
NCT06524414
Phase
Phase 2
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Pfizer
Start date
2024-07-25
Number of sites
- 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 in infants when compared to the pneumococcal vaccines that are currently in use, 20vPnC (Prevnar 20®) or another licensed pneumococcal vaccine. To ensure that the new vaccine (PG4) stays stable, it is placed in a liquid mixture of sterile water and other substances (a solution). This study will also test if there is a difference in the safety and immune effects of the new pneumococcal vaccine when it is one type of solution compared to when it is in a different type of solution. The immune response is how the body's cells; tissues and organs work together to protect the body from infection. Blood samples will be used to measure the amount of antibodies produced after the vaccination. Antibodies are proteins that protect you when an unwanted germ enters the body. This will help understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. This study is seeking participants who are: * male or female infants who are 2 months of age, * infants born at 36 weeks (about 8 and a half months) of pregnancy or later; and, * said to be healthy by the study doctor There are four groups in this study. All participants will be assigned to one of the four groups. All study vaccines will be given as a single shot into the left thigh muscle. Participants in the three groups will have 3 blood samples collected during the 1 and a half years they are in the study. The first 400 participants who enter the study will be assigned to either Group 1 or Group 2. Half the participants in Group 1 and half the participants in Group 2 will receive 4 doses at 2, 4, 6, and 12 to 15 months of age of PG4 mixed in the first solution. The other half of the participants in Groups 1 and 2 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. The main difference between Groups 1 and 2 is that participants in Group 2 will have the first blood sample collected at an earlier time than those in Group 1. Once 400 participants have been assigned to Groups 1 and 2 then 100 new participants will be assigned to Group 3. Half the participants in Group 3 will receive PG4 in the second solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Groups 3 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. Once the 100 participants have been assigned to Group 3 then 300 new participants will be assigned to Group 4. Half the participants in Group 4 will receive PG4 in the first solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Group 4 will receive 4 doses of a licensed pneumococcal comparator vaccine at 2, 4, 6, and 12 to 15 months of age. Participants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, participants will have 6 study clinic visits and 1 to 2 phone calls. At these study clinic visits, parent(s) or legal guardian(s) will be asked if the participant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.
- Short title
- A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
- Official title
- A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-05-01
- First posted
- 2024-07-29
- Registry last updated
- 2026-07-09
- Primary completion date
- 2027-05-01
- Start date
- 2024-07-25
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Pfizer
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06524414
- ClinicalTrials.gov ID
- NCT06524414
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Percentage of participants reporting local reactions within 7 days after each dose
Timeframe: Day 7
Prompted local reactions after each dose
Percentage of participants reporting systemic events within 7 days after each dose
Timeframe: Day 7
Prompted systemic reactions after each dose
Percentage of participants reporting adverse events (AEs)
Timeframe: Dose 1 to 1 month after Dose 3
AEs occurring from Dose 1 to 1 month after Dose 2
Percentage of participants reporting AEs
Timeframe: Dose 4 to 1 month after Dose 4
AEs occurring from Dose 4 to 1 month after Dose 4
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
Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs)
Timeframe: 1 month after Dose 4
Pneumococcal IgG GMCs 1 month after Dose 4
Sources for outcomes
- Sex
- All
- Age groups
- Children
- Minimum age
- 42 Days
- Maximum age
- 98 Days
- Healthy volunteers
- Yes
- Male or female infants born at >36 weeks of gestation and 2 months of age at the time of consent.
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- 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
- Northwest Arkansas Pediatric ClinicFayetteville, United States
- The Children's ClinicJonesboro, United States
- Los Ninos Children's Medical ClinicLa Puente, United States
- Los Ninos Children's Medical ClinicWest Covina, United States
- Velocity Clinical Research, Washington DCWashington D.C., United States
- Riveldi Biomedical Research and Associates - MiamiMiami Lakes, United States
- Clinical Research PrimeIdaho Falls, United States
- The Iowa ClinicAnkeny, United States
- Cotton O'Neil PediatricsTopeka, United States
- Kentucky Pediatric/ Adult ResearchBardstown, United States
- All Children PediatricsLouisville, United States
- Bluegrass Clinical Research, Inc.Louisville, United States
- LSUHSC Clinical Trials OfficeShreveport, United States
- Louisiana State University Health Sciences ShreveportShreveport, United States
- Ochsner/LSU Health Ambulatory Care CenterShreveport, United States
- University of MarylandBaltimore, United States
- UMB/CVDFrederick, United States
- Pediatric Associates of Fall RiverFall River, United States
- Boeson Research GTFGreat Falls, United States
- OBGYN AssociatesGreat Falls, United States
- Origin HealthGreat Falls, United States
- Boeson Research KALKalispell, United States
- Heart and Hands Midwifery and Family PracticeKalispell, United States
- POEM HealthcareKalispell, United States
- Blue Moose PediatricsMissoula, United States
And 43 more, listed on the interactive page.
Sources for sites
- Related resource (pmiform.com)
- 2025
- 2025-000081-28
- NCT06524414
Sources for references