This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,200
Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Percentage of participants achieving world health organization (WHO) predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 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) were presented. Exact 2-sided CI based on observed proportion of participants.
Time frame: 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Antibody GMC 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.
Time frame: 28 to 42 days after dose 1 for Group 3
Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)
Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules.
Time frame: 28 to 42 days after dose 1
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Pfizer Investigational Site
Benton, Arkansas, United States
Pfizer Investigational Site
Fayetteville, Arkansas, United States
Pfizer Investigational Site
Jonesboro, Arkansas, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Fountain Valley, California, United States
Pfizer Investigational Site
Loma Linda, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Marietta, Georgia, United States
Pfizer Investigational Site
DeKalb, Illinois, United States
...and 21 more locations
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Serotype-specific OPA GMTs 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) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.
Time frame: 28 to 42 days after dose 1 for Group 3 and 4