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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pneumococcal Disease

Intervention / Treatment
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* Other: Candidate-1
* Other: Candidate-2
* Other: Candidate-3
* Other: Candidate-4
* Other: Candidate-5
* Other: Candidate-6
* Other: Candidate Control
* Biological: 13vPnC
* Biological: PCV15


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candidate-1<br>Participants to receive a single injection of Candidate-1. | Other: Candidate-1<br>* Biological<br>|
| Experimental: Candidate-2<br>Participants to receive a single injection of Candidate-2. | Other: Candidate-2<br>* Biological<br>|
| Experimental: Candidate-3<br>Participants to receive a single injection of Candidate-3. | Other: Candidate-3<br>* Biological<br>|
| Experimental: Candidate-4<br>Participants to receive a single injection of Candidate-4. | Other: Candidate-4<br>* Biological<br>|
| Experimental: Candidate-5<br>Participants to receive a single injection of Candidate-5. | Other: Candidate-5<br>* Biological<br>|
| Experimental: Candidate-6<br>Participants to receive a single injection of Candidate-6. | Other: Candidate-6<br>* Biological<br>|
| Active Comparator: Candidate Control<br>Participants to receive a single injection of Candidate Control. | Other: Candidate Control<br>* Biological<br>|
| Other: 13-valent pneumococcal conjugate vaccine (13vPnC)<br>Participants to receive a single injection of 13vPnC. | Biological: 13vPnC<br>* 13-valent pneumococcal conjugate vaccine<br>|
| Other: 15-valent pneumococcal conjugate vaccine (PCV15)<br>Participants to receive a single injection of PCV15. | Biological: PCV15<br>* 15-valent pneumococcal conjugate vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants reporting prompted local reactions within 7 days after study intervention administration | Prompted local reactions (redness, swelling, pain at the injection site) after study intervention administration | 7 days | 
| Percentage of participants reporting prompted systemic events within 7 days after study intervention administration | Prompted systemic events (fever, headache, fatigue, muscle pain, joint pain) after study intervention administration | 7 days | 
| Percentage of participants reporting Adverse Events (AEs) within 1 month after study intervention administration | Adverse events occurring within 1 month after study intervention administration | 1 month | 
| Percentage of participants reporting Serious Adverse Events (SAEs) within 1 month after study intervention administration | SAEs occurring within 1 month after study intervention administration | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) | Pneumococcal OPA GMTs 1 month after study intervention administration | 1 month after study intervention administration |