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Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

A PHASE 1, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF PNEUMOCOCCAL CONJUGATE FORMULATIONS IN HEALTHY ADULTS 18 THROUGH 49 YEARS OF AGE

NCT05489328•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.

Eligibility

Age

18 - 49 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female participants ≥18 and ≤49 years of age at the time of consent
•Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
•Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children

Exclusion Criteria

•History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
•Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
•Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
•Known or suspected immunodeficiency or other conditions associated with immunosuppression
•Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
•Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention

Locations (18)

Orange County Research Center

Tustin, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Clinical Research Consulting

Milford, Connecticut, United States

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Qps-Mra, Llc

South Miami, Florida, United States

Centennial Medical Group

Elkridge, Maryland, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, United States

South Jersey Infectious Disease

Somers Point, New Jersey, United States

Key Dates

Start Date

August 15, 2022

Primary Completion Date

October 7, 2022

Completion Date

October 7, 2022

Last Updated

April 18, 2024

Enrollment

394

ACTUAL participants

Conditions

Pneumococcal Disease

Interventions

Candidate-1

OTHER

Candidate-2

OTHER

Candidate-3

OTHER

Candidate-4

OTHER

Candidate-5

OTHER

Candidate-6

OTHER

Candidate Control

OTHER

13vPnC

BIOLOGICAL

PCV15

BIOLOGICAL

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

NCT06731374

Pneumococcal DiseasePneumococcal Carriage

View study

RECRUITINGPHASE3

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

NCT06044077

Pneumococcal Disease

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

Inclusion Criteria

Exclusion Criteria

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan