A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan

Study Overview
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Brief Summary
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The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers. This study is enrolling participants who are: Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study Have a bodyweight of at least 3 kg Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4-dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 months) of age. Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant's health and take some blood samples during the visit.

Official Title
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A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN IN A SERIES OF 3 INFANT DOSES AND 1 TODDLER DOSE IN INFANTS IN INDIA AND TAIWAN

Conditions
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Pneumococcal Disease

Intervention / Treatment
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* Biological: 20-valent pneumococcal conjugate vaccine
* Biological: 13-valent pneumococcal conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female infants born at ≥36 weeks of gestation and approximately 2 months of age at the time of consent Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study Weight of 3.0 kg or greater at the time of randomization Exclusion Criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any other diphtheria toxoid-containing vaccine. Major known congenital malformation or serious chronic disorder Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 84 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20-valent pneumococcal conjugate vaccine<br>Pneumococcal conjugate vaccine (20vPnC) | Biological: 20-valent pneumococcal conjugate vaccine<br>* 20-valent pneumococcal conjugate vaccine<br>|
| Active Comparator: 13-valent pneumococcal conjugate vaccine<br>Pneumococcal conjugate vaccine (13vPnC) | Biological: 13-valent pneumococcal conjugate vaccine<br>* 13-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 in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country | Prompted local reactions after each dose | Day 7 | 
| Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country | Prompted systemic reactions after each dose | Day 7 | 
| Percentage of participants in India and Taiwan with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group, separately by country | Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group | Dose 1 to 1 month after Dose 3 | 
| Percentage of participants from India and Taiwan with AEs from Dose 4 through 1 month after Dose 4 in each group, separately by country | Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group | Dose 4 to 1 month after Dose 4 | 
| Percentage of participants in India and Taiwan with SAEs from Dose 1 through 1 month after Dose 4 in each group, separately by country | SAEs occurring up to 1 month after Dose 4 in each group | Dose 1 to 1 month after Dose 4 | 
| GMCs of serotype-specific IgG concentrations in Indian participants 1 month after Dose 4 in each vaccine group | IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Indian participants only | 1 month after Dose 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group, separately by country | IgG GMCs for the 20vPnC serotypes 1 month after Dose 3 | 1 month after Dose 3 | 
| Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group, separately by country | IgG concentrations for 20vPnC serotypes 1 month after Dose 3 | 1 month after Dose 3 | 
| GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group | IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Taiwanese participants only | 1 month after Dose 4 | 
| Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group, separately by country | IgG concentrations for 20vPnC serotypes 1 month after Dose 4 | 1 month after Dose 4 |