A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
Public ClinicalTrials.gov record NCT06720038. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double-Blind, Active-Controlled, Dose-Finding Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age Concomitantly With Routine Pediatric Vaccines
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06720038
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 900 participants
Conditions and interventions
Conditions
Interventions
- 0.5 mL of the low dose VAX-31 Biological
- 0.5 mL of the mid dose VAX-31 Biological
- 0.5 mL of the high dose VAX-31 Biological
- 0.5 mL dose of PCV20 Biological
- 0.5 mL of the High-PFS dose VAX-31 Biological
Biological
Eligibility (public fields only)
- Age range
- 42 Days to 89 Days
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 25, 2024 (Actual)
- Primary completion
- Dec 2027 (Estimated)
- Completion
- Dec 2027 (Estimated)
- Last update posted
- May 15, 2026
2024 – 2027
United States locations
- U.S. sites
- 45
- U.S. states
- 15
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Children's Clinic of Jonesboro, P.A | Jonesboro | Arkansas | 72401 | — |
| Matrix Clinical Research | Gardena | California | 90237 | — |
| Matrix Clinical Research | Los Angeles | California | 90057 | — |
| Orange County Research Institute | Ontario | California | 91762 | — |
| Center for Clinical Trials of San Gabriel | West Covina | California | 91790 | — |
| Children's Hospital of Colorado - Dept. of Infectious Disease | Aurora | Colorado | 80045 | — |
| SEC Clinical Research | Pensacola | Florida | 32503 | — |
| PAS Research | Tampa | Florida | 33613 | — |
| Clinical Research Prime, LLP | Idaho Falls | Idaho | 83404 | — |
| Clinical Research Prime - Rexburg | Rexburg | Idaho | 83440 | — |
| Kentucky Pediatrics/Adult Research | Bardstown | Kentucky | 40004 | — |
| ACC Pediatric Research | Haughton | Louisiana | 71037 | — |
| Complete Children's Health | Lincoln | Nebraska | 68504 | — |
| Complete Children's Health | Lincoln | Nebraska | 68505 | — |
| Be Well Clinical Studies Nebraska | Lincoln | Nebraska | 68516 | — |
| Complete Children's Health | Lincoln | Nebraska | 68516 | — |
| Complete Children's Health | Lincoln | Nebraska | 68522 | — |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | — |
| Senders Pediatrics | South Euclid | Ohio | 44121 | — |
| Cyn3rgy Research | Gresham | Oregon | 97030 | — |
| UPMC Children's Community Pediatrics - Bass Wolfson, Cranberry | Cranberry Township | Pennsylvania | 16066 | — |
| Allegheny Health & Wellness Pavilion West | Erie | Pennsylvania | 16506 | — |
| UPMC Children's Community Pediatrics - Norwin | N. Huntingdon | Pennsylvania | 15642 | — |
| UPMC Children's Community Pediatrics South Hills-Jefferson Hills | Pittsburgh | Pennsylvania | 15025 | — |
| UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP) | Pittsburgh | Pennsylvania | 15213 | — |
| UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill | Pittsburgh | Pennsylvania | 15217 | — |
| UPMC Children's Community Pediatrics-Castle Shannon | Pittsburgh | Pennsylvania | 15234 | — |
| Tribe Clinical Research, LLC dba Neighbors Clinical Research | Charleston | South Carolina | 29407 | — |
| Tribe Clinical Research/Parkside Pediatrics | Simpsonville | South Carolina | 29680 | — |
| Proactive RGV LLC | Brownsville | Texas | 78520 | — |
| Javara Inc. /Texas Health Care, PLLC | Dallas | Texas | 75001- | — |
| Oak Cliff Research Company | Dallas | Texas | 75287 | — |
| Kool Kids Pediatrics (Dynamed) | Houston | Texas | 77065 | — |
| Sunrise Pediatrics | Houston | Texas | 77077 | — |
| Mercury Clinical Research - Pediatric Associates | Houston | Texas | 77087 | — |
| University of Texas Medical Branch - Sealy Institute for Vaccine Sciences, Clinical Trials Program | League City | Texas | 77573 | — |
| Pediatric Center/Neutra Life Sciences | Richmond | Texas | 77469 | — |
| AMR - Layton | Layton | Utah | 84041 | — |
| AMR - Cottonwood | Murray | Utah | 84107 | — |
| AMR - Roy | Roy | Utah | 84067 | — |
| AMR South Jordan | South Jordan | Utah | 84095 | — |
| AMR - Syracuse | Syracuse | Utah | 84075 | — |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | — |
| Pediatric Research of Charlottesville, LLC | Gordonsville | Virginia | 22942 | — |
| Clinical Research Partners, LLC. | Richmond | Virginia | 23226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06720038, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 15, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06720038 live on ClinicalTrials.gov.