Jonathan Duffy.

The 6 observed intussusception cases were more than the 0.72 cases which were expected on the basis of historical data . Similarly, the noticed number of instances after dose 2 was significantly greater than the expected amount of 0.49. The 2 2 cases that were observed after dose 1 were less than the minimal number of required instances , so the log-likelihood ratio was not calculated. As compared with the historical rate of intussusception in the VSD human population, the attributable threat of intussusception for infants getting the monovalent rotavirus vaccine was 5.3 cases per 100,000 infants receiving the two doses of vaccine. We performed a cluster analysis of all intussusception cases in the emergency division or hospital environment within thirty days after monovalent rotavirus vaccination.Confidentiality agreements had been in place between the sponsor and the investigators. The sponsor was responsible for data management and processing, statistical analysis, and reporting of the full total results. Data evaluation was conducted by three of the authors. The first draft of the manuscript was written by the first writer, with assistance from two authors employed by the sponsor and medical authors paid by the sponsor. All of the decision was made by the authors to post the manuscript meant for publication. All authors attest to the veracity of the info, analyses, and trial vouch and protocol that the trial was conducted and reported consistently with the protocol.