Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
Status and phase
Completed
Phase 1
Conditions
Pneumococcal Disease
Treatments
Other: Candidate-6
Other: Candidate-5
Other: Candidate-1
Other: Candidate-2
Biological: PCV15
Other: Candidate-4
Other: Candidate Control
Biological: 13vPnC
Other: Candidate-3
Details and patient eligibility
About
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.
Enrollment
394 patients
Sex
All
Ages
18 to 49 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
394 participants in 9 patient groups
Candidate-1
Experimental group
Description:
Participants to receive a single injection of Candidate-1.
Treatment:
Other: Candidate-1
Candidate-2
Experimental group
Description:
Participants to receive a single injection of Candidate-2.
Treatment:
Other: Candidate-2
Candidate-3
Experimental group
Description:
Participants to receive a single injection of Candidate-3.
Treatment:
Other: Candidate-3
Candidate-4
Experimental group
Description:
Participants to receive a single injection of Candidate-4.
Treatment:
Other: Candidate-4
Candidate-5
Experimental group
Description:
Participants to receive a single injection of Candidate-5.
Treatment:
Other: Candidate-5
Candidate-6
Experimental group
Description:
Participants to receive a single injection of Candidate-6.
Treatment:
Other: Candidate-6
Candidate Control
Active Comparator group
Description:
Participants to receive a single injection of Candidate Control.
Treatment:
Other: Candidate Control
13-valent pneumococcal conjugate vaccine (13vPnC)
Other group
Description:
Participants to receive a single injection of 13vPnC.
Treatment:
Biological: 13vPnC
15-valent pneumococcal conjugate vaccine (PCV15)
Other group
Description:
Participants to receive a single injection of PCV15.
Treatment:
Biological: PCV15
Trial contacts and locations
18
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Data sourced from clinicaltrials.gov
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