Pneumococcal Disease, Invasive Clinical Trial
Official title:
A Phase 3, Randomized, Blinded, Active-controlled Study to Evaluate the Immunogenicity and Safety of Walvax's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-TT) as Compared to Pfizer's 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Co-administered With EPI Vaccines at 2, 4, and 12-15 Months of Age, to Healthy Infants in Indonesia
Hypothesis of non-inferiority test for seropositive rate and GMC in each serotype
H0: the immune responses elicited by PCV13-TT are inferior to those elicited by PCV13 HA: the immune responses elicited by PCV13-TT are non-inferior to those elicited by PCV13. Non-inferiority of the immune responses elicited by PCV13-TT will be declared if both of the following criteria are met: (1) the lower limit of the 2-sided 95% CI of the difference (PCV13-TT-PCV13) in proportions of responders who achieving the threshold of 0.35 µg/ml is >-10%; and (2) the lower limit of the 2-sided 95% CI of the GMC ratio (PCV13-TT/PCV13) is >0.5. Thus, the familywise type I error will not be inflated. ;