Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

Official Title
-----------------
A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar

Conditions
-----------------
Pneumococcal Vaccines

Intervention / Treatment
-----------------
* Biological: 13vPnC
* Biological: 13vPnC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children previously immunized with 1 or 2 doses of Prevenar. Group 1: Male or female subjects between the age of >=140 and <=196 days of age at time of enrollment. Group 2: Male or female subjects between the age of >=336 and <=392 days of age at time of enrollment Available for entire study period. Exclusion Criteria: Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component. Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.

Ages Eligible for Study
-----------------
Minimum Age: 140 Days
Maximum Age: 392 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Biological: 13vPnC<br>* 13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.<br>|
| Experimental: Group 2<br> | Biological: 13vPnC<br>* 13vPnC will be administered by intramuscular injection at approximately 12 months of age.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. | 1 month after the toddler dose (13 months of age) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 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. Exact 2-sided CI based on the observed proportion of participants. | 1 Month after the infant series (6 months of age) | 
| GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw. | 1 Month after the infant series (6 months of age) | 
| GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw. | 12 months of age (prior to toddler dose) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects, Vaccines, Pneumococcal