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Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator

ClinicalTrials.gov ID: NCT04525599

Public ClinicalTrials.gov record NCT04525599. 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.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 12:46 AM EDT

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 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the safety and tolerability of three dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in toddlers who have previously been administered the routine three-dose series of PCV13. This study will also evaluate the immunogenicity (production of an immune response) of three different dose levels of ASP3772 in comparison to the active comparator PCV13 in toddlers who have previously been administered the routine three-dose series of PCV13.

Study identification

NCT ID
NCT04525599
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Affinivax, Inc.
Industry
Enrollment
75 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
12 Months to 15 Months
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
Sep 21, 2020
Primary completion
Apr 5, 2022
Completion
Apr 5, 2022
Last update posted
Jun 5, 2022

2020 – 2022

United States locations

U.S. sites
17
U.S. states
12
U.S. cities
17
Facility City State ZIP Site status
Dermatology Trial Associates Bryant Arkansas 72022
The Childrens Clinic Jonesboro Arkansas 72401
Emmaus Research Center, Inc Anaheim California 92804
Madera Family Medical Group Madera California 93637
Ctr Clin Trials San Gabriel West Covina California 91790
Gentle Medicine Associates Boynton Beach Florida 33435
Kentucky Pediatric/Adult Research Bardstown Kentucky 40004
Meridian Clinical Research Baton Rouge Louisiana 70806
PMG Research Statesville North Carolina 28625
Oklahoma State University Center for Health Sciences Tulsa Oklahoma 74127
Pediatrics Medical Associates East Norriton Pennsylvania 19401
Coastal Pediatric Associates Charleston South Carolina 29414
University of Texas Medical Branch Galveston Texas 77555
Houston Clinical Research Associates Houston Texas 77090
Tanner Clinic Layton Utah 84041
Pediatric Care Provo Utah 84604
MultiCare Institute Spokane Washington 99202

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 NCT04525599, 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 Jun 5, 2022 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04525599 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →