A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years

Study Overview
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Brief Summary
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This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).

Official Title
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A Phase 1, Randomized, Controlled, Observer-blinded Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults Aged 18 To 49 Years

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: Multivalent
* Biological: Tdap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults 18 to 49 years of age. Healthy adults determined by medical history, physical examination, laboratory screening, and clinical judgment to be eligible for the study. Negative serum pregnancy test for all female subjects who are of childbearing potential. Exclusion Criteria: Baseline laboratory test results outside of the normal reference range considered clinically significant. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) associated with a vaccine. History of culture-proven invasive disease caused by S pneumoniae. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12 months before investigational product administration, or planned receipt through study participation. Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study participation and for at least 6 months after the last dose of investigational product.

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multivalent<br>Pneumococcal conjugate vaccine | Biological: Multivalent<br>* Pneumococcal conjugate vaccine<br>|
| Active Comparator: Tdap<br>Tetanus, diphtheria, and pertussis vaccine | Biological: Tdap<br>* Tetanus, diphtheria, and pertussis vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects reproting prompted local reactions within 14 days after vaccination (redness, swelling. limitation of arm movement, and pain at injection site). |  | Day 15 | 
| Percentage of subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, chills, rash, decreased appetite, nausea/vomiting, new muscle pain, aggravated muscle pain, new joint pain, and aggravated joint pain). |  | Day 15 | 
| Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination. |  | 1 month after vaccination | 
| Percentage of subjects with clinical laboratory abnormalities after vaccination. |  | Day 6 | 
| Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. |  | 6 months after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 1 month after vaccination. |  | 1 month after vaccination | 
| Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) measured from before vaccination to 1 month after vaccination. |  | 1 month after vaccination |