A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
Condition(s) studied
Investigational drug(s) / intervention(s)
0.5 mL of the low dose VAX-31: 31 valent pneumococcal conjugate vaccine
0.5 mL of the mid dose VAX-31: 31 valent pneumococcal conjugate vaccine
0.5 mL of the high dose VAX-31: 31 valent pneumococcal conjugate vaccine
0.5 mL dose of PCV20: 20 valent pneumococcal conjugate vaccine
0.5 mL of the High-PFS dose VAX-31: 31 valent pneumococcal conjugate vaccine
Study 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.
Eligibility
Primary outcome measure(s)
- Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination — 7 days after each vaccination
Solicited local reactions include erythema, edema, and tenderness at the injection site - Percentage of subjects with any solicited systemic AE within 7 days after each vaccination — 7 days after each vaccination
Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep - Percentage of subjects with any unsolicited AE within 1 month after each vaccination — 1 months after each vaccination
Percentage of subjects with unsolicited AE - Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination — 6 months after last vaccination
Percentage of subjects with MAAE - Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination — 6 months after last vaccination
Percentage of subjects with SAE - Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination — 6 months after last vaccination
Percentage of subjects with NOCI
Trial sites (48)
| Facility | City | Region | Status |
|---|---|---|---|
| The Children's Clinic of Jonesboro, P.A | Jonesboro | Arkansas | |
| Matrix Clinical Research | Gardena | California | |
| Matrix Clinical Research | Los Angeles | California | |
| Orange County Research Institute | Ontario | California | |
| Center for Clinical Trials of San Gabriel | West Covina | California | |
| Children's Hospital of Colorado - Dept. of Infectious Disease | Aurora | Colorado | |
| SEC Clinical Research | Pensacola | Florida | |
| PAS Research | Tampa | Florida | |
| Clinical Research Prime, LLP | Idaho Falls | Idaho | |
| Clinical Research Prime - Rexburg | Rexburg | Idaho | |
| Kentucky Pediatrics/Adult Research | Bardstown | Kentucky | |
| ACC Pediatric Research | Haughton | Louisiana | |
| Complete Children's Health | Lincoln | Nebraska | |
| Complete Children's Health | Lincoln | Nebraska | |
| Be Well Clinical Studies Nebraska | Lincoln | Nebraska | |
| Complete Children's Health | Lincoln | Nebraska | |
| Complete Children's Health | Lincoln | Nebraska | |
| Ohio Pediatric Research Association | Dayton | Ohio | |
| Senders Pediatrics | South Euclid | Ohio | |
| Cyn3rgy Research | Gresham | Oregon | |
| UPMC Children's Community Pediatrics - Bass Wolfson, Cranberry | Cranberry Township | Pennsylvania | |
| Allegheny Health & Wellness Pavilion West | Erie | Pennsylvania | |
| UPMC Children's Community Pediatrics - Norwin | N. Huntingdon | Pennsylvania | |
| UPMC Children's Community Pediatrics South Hills-Jefferson Hills | Pittsburgh | Pennsylvania | |
| UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP) | Pittsburgh | Pennsylvania | |
| UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill | Pittsburgh | Pennsylvania | |
| UPMC Children's Community Pediatrics-Castle Shannon | Pittsburgh | Pennsylvania | |
| Tribe Clinical Research, LLC dba Neighbors Clinical Research | Charleston | South Carolina | |
| Tribe Clinical Research/Parkside Pediatrics | Simpsonville | South Carolina | |
| Proactive RGV LLC | Brownsville | Texas | |
| Javara Inc. /Texas Health Care, PLLC | Dallas | Texas | |
| Oak Cliff Research Company | Dallas | Texas | |
| Kool Kids Pediatrics (Dynamed) | Houston | Texas | |
| Sunrise Pediatrics | Houston | Texas | |
| Mercury Clinical Research - Pediatric Associates | Houston | Texas | |
| University of Texas Medical Branch - Sealy Institute for Vaccine Sciences, Clinical Trials Program | League City | Texas | |
| Pediatric Center/Neutra Life Sciences | Richmond | Texas | |
| AMR - Layton | Layton | Utah | |
| AMR - Cottonwood | Murray | Utah | |
| AMR - Roy | Roy | Utah |
+ 8 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06720038 on ClinicalTrials.gov ↗ ← All trials in the USA