Perform Another (Advanced) Search

1.  Newly Approved Drug Therapies (891) Rotateq (rotavirus vaccine, live oral pentavalent), Merck,
...Study Commitments • A large-scale observational post-licensure safety study to evaluate the incidence of intussusception and other safety parameters in recipients of Rotateq in approximately 44,000 subjects (adjustments to the sample size will be made based on the background rate of intussusception). The study will be designed to detect an increased risk of intussusception due to vaccine ...
View Page

2.  Newly Approved Drug Therapies (981) Rotarix (Rotavirus Vaccine, Live, Oral), GlaxoSmithKline,
...post-licensure safety study in the U.S to assess the potential serious risk of intussusception and other serious adverse effects (specifically Kawasaki disease, hospitalizations due to acute lower respiratory tract ...
...subjects (adjustments to the sample size will be made based on the background rate of intussusception). The study will be designed to detect an increased relative risk of intussusception due to ...
View Page

3.  CenterWatch: New Medical Therapies in Disease Category (71), Gastrointestinal Diseases and Disorders
...serious adverse events among subjects receiving the vaccine, vs. placebo. No increase in rates of intussusception was noted among subjects receiving the vaccine (a serious complication associated with previous rotavirus vaccines ...
View Page