A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants

NCT06720038 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: VAX31-201
• Study Type: interventional
• Target: 905
• Locations: 2 countries
• Sites: 48

Brief Summary

The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.

Conditions

Pneumococcal Vaccines

Keywords

31 Valent PCV; Pneumonia; Pneumococcal Infection

Outcome Measures

Primary Outcomes (6)

• Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination

  Solicited local reactions include erythema, edema, and tenderness at the injection site

  7 days after each vaccination

• Percentage of subjects with any solicited systemic AE within 7 days after each vaccination

  Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep

  7 days after each vaccination

• Percentage of subjects with any unsolicited AE within 1 month after each vaccination

  Percentage of subjects with unsolicited AE

  1 months after each vaccination

• Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination

  Percentage of subjects with MAAE

  6 months after last vaccination

• Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination

  Percentage of subjects with SAE

  6 months after last vaccination

• Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination

  Percentage of subjects with NOCI

  6 months after last vaccination

Secondary Outcomes (3)

• Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 3

  1 month after Dose 3

• Serotype-specific IgG antibody geometric mean concentration (GMC) 1 month after Dose 3

  1 month after Dose 3

• Serotype-specific IgG antibody GMC 1 month after Dose 4

  1 month after Dose 4

Study Arms (5)

VAX-31 Low

EXPERIMENTAL

Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.

Biological: 0.5 mL of the low dose VAX-31

VAX-31 Mid

EXPERIMENTAL

Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.

Biological: 0.5 mL of the mid dose VAX-31

VAX-31 High

EXPERIMENTAL

Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.

Biological: 0.5 mL of the high dose VAX-31

PCV20

ACTIVE COMPARATOR

Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age.

Biological: 0.5 mL dose of PCV20

VAX-31 High-PFS

EXPERIMENTAL

Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.

Biological: 0.5 mL of the High-PFS dose VAX-31

Interventions

0.5 mL of the low dose VAX-31 BIOLOGICAL

31 valent pneumococcal conjugate vaccine

VAX-31 Low

0.5 mL of the mid dose VAX-31 BIOLOGICAL

31 valent pneumococcal conjugate vaccine

VAX-31 Mid

0.5 mL of the high dose VAX-31 BIOLOGICAL

31 valent pneumococcal conjugate vaccine

VAX-31 High

0.5 mL dose of PCV20 BIOLOGICAL

20 valent pneumococcal conjugate vaccine

PCV20

0.5 mL of the High-PFS dose VAX-31 BIOLOGICAL

31 valent pneumococcal conjugate vaccine

VAX-31 High-PFS

Eligibility Criteria

• Age: 42 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male or female infant ≥42 days to ≤89 days.
• Full-term infant at least 37 weeks gestational age at birth.
• Afebrile for ≥72 hours with an tympanic or rectal temperature \<38.0°C (\<100.4°F) before receipt of study vaccine.\*Criterion applies to each vaccination. If not met, visit may be rescheduled for a time when no longer febrile for ≥72 hours.
• Able to attend all scheduled visits and comply with the study procedures.
• Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
• Subject's parent/legal guardian is able to fill out an eDiary of solicited AE and take daily tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
• Subject's parent/legal guardian has an email address and access to a computer or smartphone with internet to complete the eDiary.

You may not qualify if:

• History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
• Previous receipt of a licensed or investigational vaccine (excluding 1 dose of hepatitis B vaccine).
• Known hypersensitivity to any vaccine.
• Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
• History of failure to thrive or prior hospitalization for any chronic condition.
• Subject has a bleeding disorder contraindicating IM vaccination.
• Subject or his/her mother has documented hepatitis B surface antigen-positive test.
• Subject has a known neurologic or cognitive behavioral disorder.
• Subject has a known clinically significant congenital malformation or serious chronic disorder.
• Receipt of a blood transfusion or blood products, including immunoglobulins.
• Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or plans to receive another investigational product while on study.
• Any infant who cannot be adequately followed for safety according to the protocol plan.
• Any other reason that in the opinion of the Investigator may interfere with the evaluation required by the study.

Sponsors & Collaborators

• Vaxcyte, Inc.: lead

Study Sites (48)

The Children's Clinic of Jonesboro, P.A

Jonesboro, Arkansas, 72401, United States

Location

Matrix Clinical Research

Gardena, California, 90237, United States

Location

Matrix Clinical Research

Los Angeles, California, 90057, United States

Location

Orange County Research Institute

Ontario, California, 91762, United States

Location

Center for Clinical Trials of San Gabriel

West Covina, California, 91790, United States

Location

Children's Hospital of Colorado - Dept. of Infectious Disease

Aurora, Colorado, 80045, United States

Location

SEC Clinical Research

Pensacola, Florida, 32503, United States

Location

PAS Research

Tampa, Florida, 33613, United States

Location

Clinical Research Prime, LLP

Idaho Falls, Idaho, 83404, United States

Location

Clinical Research Prime - Rexburg

Rexburg, Idaho, 83440, United States

Location

Kentucky Pediatrics/Adult Research

Bardstown, Kentucky, 40004, United States

Location

ACC Pediatric Research

Haughton, Louisiana, 71037, United States

Location

Complete Children's Health

Lincoln, Nebraska, 68504, United States

Location

Complete Children's Health

Lincoln, Nebraska, 68505, United States

Location

Be Well Clinical Studies Nebraska

Lincoln, Nebraska, 68516, United States

Location

Complete Children's Health

Lincoln, Nebraska, 68516, United States

Location

Complete Children's Health

Lincoln, Nebraska, 68522, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Senders Pediatrics

South Euclid, Ohio, 44121, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

UPMC Children's Community Pediatrics - Bass Wolfson, Cranberry

Cranberry Township, Pennsylvania, 16066, United States

Location

Allegheny Health & Wellness Pavilion West

Erie, Pennsylvania, 16506, United States

Location

UPMC Children's Community Pediatrics - Norwin

North Huntingdon, Pennsylvania, 15642, United States

Location

UPMC Children's Community Pediatrics South Hills-Jefferson Hills

Pittsburgh, Pennsylvania, 15025, United States

Location

UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP)

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill

Pittsburgh, Pennsylvania, 15217, United States

Location

UPMC Children's Community Pediatrics-Castle Shannon

Pittsburgh, Pennsylvania, 15234, United States

Location

Tribe Clinical Research, LLC dba Neighbors Clinical Research

Charleston, South Carolina, 29407, United States

Location

Tribe Clinical Research/Parkside Pediatrics

Simpsonville, South Carolina, 29680, United States

Location

Proactive RGV LLC

Brownsville, Texas, 78520, United States

Location

Javara Inc. /Texas Health Care, PLLC

Dallas, Texas, 75001-, United States

Location

Oak Cliff Research Company

Dallas, Texas, 75287, United States

Location

Kool Kids Pediatrics (Dynamed)

Houston, Texas, 77065, United States

Location

Sunrise Pediatrics

Houston, Texas, 77077, United States

Location

Mercury Clinical Research - Pediatric Associates

Houston, Texas, 77087, United States

Location

University of Texas Medical Branch - Sealy Institute for Vaccine Sciences, Clinical Trials Program

League City, Texas, 77573, United States

Location

Pediatric Center/Neutra Life Sciences

Richmond, Texas, 77469, United States

Location

AMR - Layton

Layton, Utah, 84041, United States

Location

AMR - Cottonwood

Murray, Utah, 84107, United States

Location

AMR - Roy

Roy, Utah, 84067, United States

Location

AMR South Jordan

South Jordan, Utah, 84095, United States

Location

AMR - Syracuse

Syracuse, Utah, 84075, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

Pediatric Research of Charlottesville, LLC

Gordonsville, Virginia, 22942, United States

Location

Clinical Research Partners, LLC.

Richmond, Virginia, 23226, United States

Location

Ponce Medical School Foundation Inc. / CAIMED Center

Ponce, PR 716, Puerto Rico

Location

BRCR Global Puerto Rico

San Juan, PR 907, Puerto Rico

Location

Caribbean Medical Research Center

San Juan, PR 918, Puerto Rico

Location

MeSH Terms

Conditions

Pneumonia; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual participant data will be shared after deidentification and made available starting 6 months after initial product approval.
• Access Criteria: Criteria will depend on the specific proposal received and may include qualification of the scientific researchers, potential contribution to the research field, scientific rigor of statistical and analytical methods, and other criteria appropriate for the proposal.

Locations

PR (3); US (45)