Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.

Official Title
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Phase 2, Randomized, Active-Controlled, Double-Blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Korea

Conditions
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Pneumococcal Vaccine

Intervention / Treatment
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* Biological: 13-valent pneumococcal conjugate vaccine
* Biological: 7-valent pneumococcal conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy 2-month-old-infants (42 to 98 days) Available for the entire study period (14 months) Exclusion Criteria: Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine A previous severe reaction to any vaccine or vaccine-related component

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 98 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>13vPnC | Biological: 13-valent pneumococcal conjugate vaccine<br>* 13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.<br>|
| Active Comparator: 2<br>7vPnC | Biological: 7-valent pneumococcal conjugate vaccine<br>* 7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). | 1 month after the infant series (7 months of age) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). Exact 2-sided CI was based on the observed percentage of participants. | 1 month after the toddler dose (13 months of age) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, against, pneumococcal, disease, Vaccine