A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.

Official title

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

Overview

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. It will also assess how the new vaccine works in comparison to the one that is currently in use when given with other childhood vaccines. 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 infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. There are three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are: * infants who are 2 months of age in Group 1; * infants who are 2 to 6 months of age in Groups 2 and 3; and * said to be healthy by the study doctor About 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving 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. About 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. About 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving either PG4 into the left thigh muscle, PG4 under the skin of the left thigh, or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. Infants in Group 1 will take part in this study for about 16 to 19 months (about 1 and a half years). Infants in Groups 2 and 3 will take part in this study for 12 to 21 months (about 1 to 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. Infants will have 3 blood samples collected.

Interventions

• Biological PG4
  Multivalent Pneumococcal Vaccine
• Biological 20-valent pneumococcal conjugate vaccine (20vPnC)
  20-valent pneumococcal conjugate vaccine (20vPnC)

Primary outcome measures

• Percentage of participants reporting local reactions within 7 days after each dose [Time frame: Day 7]
• Percentage of participants reporting systemic events within 7 days after each dose [Time frame: Day 7]
• Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3 [Time frame: Dose 1 to 1 month after Dose 3]
• Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4 [Time frame: Dose 4 to 1 month after Dose 4]
• Percentage of participants reporting serious adverse events (SAEs) [Time frame: Dose 1 to 6 months after Dose 4]
• Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3 [Time frame: 1 month after Dose 3]
• Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4 [Time frame: 1 month after Dose 4]

Secondary outcome measures (12)

• Pneumococcal IgG GMCs 1 month after Dose 3 [Time frame: 1 month after Dose 3]
• Percentage of participants with serotype 3 specific predefined pneumococcal IgG concentrations 1 month after Dose 3 [Time frame: 1 month after Dose 3]
• Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4 [Time frame: 1 month after Dose 4]
• Differences in percentages of participants with predefined pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3 [Time frame: 1 month after Dose 3]
• Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4 [Time frame: 1 month after Dose 4]
• Pneumococcal opsonophagocytic activity (OPA) titers 1 month after Dose 3 [Time frame: 1 month after Dose 3]
• Pneumococcal OPA titers prior to Dose 4 [Time frame: Prior to Dose 4]
• Pneumococcal OPA titers 1 month after Dose 4 [Time frame: 1 month after Dose 4]
• Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4 [Time frame: 1 month after Dose 4]
• Pneumococcal IgG concentrations 1 month after Dose 3 [Time frame: 1 month after Dose 3]
• Pneumococcal IgG concentrations prior to Dose 4 [Time frame: Prior to Dose 4]
• Pneumococcal IgG concentrations 1 month after Dose 4 [Time frame: 1 month after Dose 4]

Eligibility criteria

Inclusion criteria

• infants who are 2 months of age in Group 1.
• infants who are 2 to 6 months of age in Groups 2 and 3.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

United States · 79 centers

• Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates — Birmingham
• University of Alabama at Birmingham - School of Medicine — Birmingham
• KUR Research, LLC — Centreville
• Northwest Arkansas Pediatric Clinic — Fayetteville
• The Children's Clinic of Jonesboro, P.A. — Jonesboro
• Helios Clinical Research — Sherwood
• San Gabriel Woman's Health — Arcadia
• Family Medical Clinic — El Monte
• … and 71 more centers

Japan · 10 centers

• TOYOTA Memorial Hospital — Toyota-shi
• … and 9 more centers

Puerto Rico · 8 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07629440 · C4931008

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗