Clinical trial NCT06524414: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 800
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Percentage of participants reporting local reactions within 7 days after each dose
timeFrame: Day 7
measure: Percentage of participants reporting systemic events within 7 days after each dose
timeFrame: Day 7
measure: Percentage of participants reporting adverse events (AEs)
timeFrame: Dose 1 to 1 month after Dose 3
measure: Percentage of participants reporting AEs
timeFrame: Dose 4 to 1 month after Dose 4
measure: Percentage of participants reporting serious adverse events (SAEs)
timeFrame: Dose 1 to 6 months after Dose 4
Secondary outcomes:
measure: Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs)
timeFrame: 1 month after Dose 4
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic
state: Arkansas
city: Daly City
country: United States
facility: Kaiser Permanente Daly City
state: California
city: La Puente
country: United States
facility: Los Ninos Children's Medical Clinic
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose
state: California
city: Ventura
country: United States
facility: Private Practice - Dr. Carey Chronis
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Walnut Creek
state: California
city: West Covina
country: United States
facility: Los Ninos Children's Medical Clinic
state: California
city: Miami Lakes
country: United States
facility: Riveldi Biomedical Research and Associates - Miami
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Rexburg
country: United States
facility: Clinical Research Prime Rexburg
state: Idaho
city: Ankeny
country: United States
facility: The Iowa Clinic
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Pediatrics
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/ Adult Research
state: Kentucky
city: Louisville
country: United States
facility: All Children Pediatrics
state: Kentucky
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Shreveport
country: United States
facility: LSUHSC Clinical Trials Office
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Shreveport
state: Louisiana
city: Shreveport
country: United States
facility: Ochsner/LSU Health Ambulatory Care Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Frederick
country: United States
facility: UMB/CVD
state: Maryland
city: Fall River
country: United States
facility: Pediatric Associates of Fall River
state: Massachusetts
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: East Syracuse
country: United States
facility: Child Health Care Associates
state: New York
city: Durham
country: United States
facility: Duke Vaccine and Trials Unit
state: North Carolina
city: Durham
country: United States
facility: Durham Pediatrics at North Duke Street
state: North Carolina
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Assn.
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion
state: Pennsylvania
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Dallas
country: United States
facility: Javara - Privia Medical Group North Texas - Dallas
state: Texas
city: Dallas
country: United States
facility: Oak Cliff Research Company, LLC
state: Texas
city: Dallas
country: United States
facility: Oak Cliff Research Company, LLC
state: Texas
city: Edinburg
country: United States
facility: PAS Research - McAllen
state: Texas
city: Houston
country: United States
facility: Pediatric Associates
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Associates
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Kaysville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Layton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Murray
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Provo
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Roy
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: South Jordan
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Syracuse
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Guayama
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: San Juan
country: Puerto Rico
facility: BRCR Global Puerto Rico
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico - Medical Sciences Campus
city: San Juan
country: Puerto Rico
facility: The Hispanic Alliance for Clinical and Translational Research
city: Trujillo Alto
country: Puerto Rico
facility: San Miguel Medical
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: