Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
Public ClinicalTrials.gov record NCT05844423. 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
Randomized, Observer-Blind, Active-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of 24-Valent PCV (VAX-24) in Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age With 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 and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 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 the remainder of the sample size.
Study identification
- NCT ID
- NCT05844423
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 802 participants
Conditions and interventions
Conditions
Interventions
- 0.5 ml dose of 1.1 mcg VAX-24 Biological
- 0.5 ml dose of PCV20 Biological
- 0.5 ml dose of 2.2 mcg VAX-24 Biological
- 0.5 ml dose of 2.2/4.4 mcg VAX-24 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
- Mar 29, 2023 (Actual)
- Primary completion
- Aug 25, 2025 (Actual)
- Completion
- Aug 25, 2025 (Actual)
- Last update posted
- Sep 11, 2025
2023 – 2025
United States locations
- U.S. sites
- 32
- U.S. states
- 13
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Children's Clinic of Jonesboro, P.A. | Jonesboro | Arkansas | 72401 | — |
| Madera Family Medical Group | Madera | California | 93637 | — |
| Jedidiah Clinical Research | Tampa | Florida | 33617 | — |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | — |
| ACC Pediatric Research | Haughton | Louisiana | 71037 | — |
| Meridian Clinical Research | Hastings | Nebraska | 68901 | — |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68504 | — |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68505 | — |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68516 | — |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68522 | — |
| Ohio Pediatric Research Assn. | Dayton | Ohio | 45414 | — |
| UPMC Bass Wolfson Cranberry | Cranberry Township | Pennsylvania | 16066 | — |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | — |
| UPMC Children's Community Pediatrics South Hills-Jefferson Hills | Jefferson Hills | Pennsylvania | 15025 | — |
| UPMC Primary Care Center Oakland | 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 | — |
| Palmetto Pediatrics, PA | North Charleston | South Carolina | 29406 | — |
| Tribe Clinical Research at Parkside Pediatrics | Simpsonville | South Carolina | 29680 | — |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Ventavia Research Group | Burleson | Texas | 76028 | — |
| Ventavia | Houston | Texas | 77008 | — |
| Kool Kids Pediatrics | Houston | Texas | 77065 | — |
| Pediatric Associates | Houston | Texas | 77087 | — |
| Pediatric Center | Richmond | Texas | 77469 | — |
| Alliance for Multispecialty Research | Layton | Utah | 84041 | — |
| Alliance for Multispecialty Research | Murray | Utah | 84107 | — |
| Alliance for Multispecialty Research | Provo | Utah | 84604 | — |
| Alliance for Multispecialty Research | Roy | Utah | 84067 | — |
| Alliance for Multispecialty Research | Syracuse | Utah | 84075 | — |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05844423, 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 Sep 11, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05844423 live on ClinicalTrials.gov.