Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

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 Taiwan.

Official Title
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A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND TRIAL EVALUATING THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS GIVEN WITH ROUTINE PEDIATRIC VACCINATION IN TAIWAN

Conditions
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Vaccines, Pneumococcal Conjugate Vaccine

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


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 vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines A previous anaphylactic 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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No

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 (13vPnC)<br>* 13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.<br>|
| Active Comparator: 2<br>7vPnC | Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)<br>* 7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 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 Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (CI) for the 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) are presented. | 1 month after the infant series (7 months of age) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 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) are presented. | 1 month after toddler dose (16 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