RotaTeq®, a pentavalent rotavirus vaccine: Efficacy and safety among infants in Europe

Results from a Randomized Clinical Trial of Coadministration of RotaTeq, a Pentavalent Rotavirus Vaccine, and NeisVac-C, a Meningococcal Serogroup C Conjugate Vaccine

“…The immunologic findings for RotaTeq observed in the present study are consistent with those described in other clinical trials (2,21,23), with Ͼ96% of the vaccine recipients achieving at least a 3-fold increase in serum rotavirus IgA antibody titer. SNA responses to G1 to G4 and P1A [8] and GMTs were also as expected from previous trials (2,17,21,22,23).…”

“…It is a live attenuated human-bovine reassortant rotavirus vaccine consisting of the genes encoding the G1, G2, G3, G4, and P1A [8] outer capsid proteins of human rotaviruses in monoreassortants containing a bovine rotavirus genetic background. RotaTeq has been demonstrated to be efficacious, immunogenic, and well tolerated when it is given alone or concomitantly with routine childhood vaccines (4,5,17,21,22,23,24). On the basis of the current summary of product characteristics (SmPC) for RotaTeq in Europe, the first dose should be given at between 6 weeks and 12 weeks of age and all three doses should be given before 26 weeks of age (13).…”

Summary of effectiveness and impact of rotavirus vaccination with the oral pentavalent rotavirus vaccine: A systematic review of the experience in industrialized countries

“…[15][16][17] Direct costs associated with medical care for review review (95% CI 91.3-96.8%) over 2 years post-vaccination. 21 Rotarix (GlaxoSmithKline Biologicals, Rixensart, Belgium) is an oral live, monovalent [G1P (8)], attenuated, human RV vaccine that has been licensed in the EU since 2006 and in the US since 2008. It is administered as a two-dose series from 6 weeks of age, with a minimum of 4 weeks between doses.…”

Safety assessment of adjuvanted vaccines: Methodological considerations

“…These studies enrolled more than 60,000 children in order to rule out an increased risk of intussusception. 49,50 Although no increased risk of intussusception was found in these large trials before licensure, postlicensure data from international settings suggest the possibility of a small increase in the risk of intussusception within 7 d after receiving first dose of rotavirus vaccine (estimated risk in the US of 1 to 3 infants per 100,000 vaccinated). 51 Comparisons of any adjuvanted vaccine versus saline placebo or unadjuvanted antigen, although preferred for the assessment The acceptable benefit-risk profile is established during the clinical development phase, leading to licensure of the vaccine for the target population.…”