This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,866
1 dose at 2, 4, 6 and 12 months of age
1 dose at 2, 4, 6 and 12 months of age
Pfizer Investigational Sites (7)
Beersheba, Beer-Sheva, Israel
Pfizer Investigational Site
Shaqib al-Salam, Segev Shalom, Israel
Pfizer Investigational Site
Ksaife, Israel
Pfizer Investigational Site
Rahat, Israel
Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age
A new acquisition was defined as the detection of a serotype (here 6A' \[6A + 6C\] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.
Time frame: Month 7 through Month 24
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age
Time frame: Month 7, 12, 13, 18, 24
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Pfizer Investigational Site
Rahat A, Israel