title: Efficacy of the pentavalent rotavirus vaccine, RotaTeq® (RV5), between doses of a 3-dose series and with less than 3 doses (incomplete regimen).
abstract: Post-hoc analyses of the Rotavirus Efficacy and Safety Trial (REST) were conducted to determine whether the pentavalent rotavirus vaccine (RV5) confers early protection against rotavirus gastroenteritis (RVGE) before completion of the 3-dose regimen. To evaluate the efficacy of RV5 between doses in reducing the rates of RVGE-related hospitalizations and emergency department (ED) visits in infants who ultimately received all 3 doses of RV5/placebo, events occurring from 2 weeks after the first and second doses to receipt of the subsequent dose (Analysis A) and events occurring from 2 weeks after the first and second doses to 2 weeks after the subsequent dose (Analysis B) were analyzed. In Analysis A, RV5 reduced the rates of combined hospitalizations and ED visits for G1-G4 RVGE or RVGE regardless of serotype between doses 1 and 2 by 100% (95% confidence interval [CI]: 72-100%) or 82% (95% CI: 39-97%), respectively, and between doses 2 and 3, RV5 reduced the rates of combined hospitalizations and ED visits for G1-G4 RVGE or RVGE regardless of serotype by 91% (95% CI: 63-99%) or 84% (95% CI: 54-96%), respectively. Similar rate reductions were observed in Analysis B. These data suggest that RV5 provides a high level of protection between doses against hospitalizations and ED visits for RVGE starting as early as 14 days after the first dose.
authors: The Alpert Medical School of Brown University and Hasbro Children's Hospital, Providence, RI, USA.
authors: Penelope H
authors: PH
authors: Dennehy
authors: Timo
authors: T
authors: Vesikari
authors: David O
authors: DO
authors: Matson
authors: Robbin F
authors: RF
authors: Itzler
authors: Michael J
authors: MJ
authors: Dallas
authors: Michelle G
authors: MG
authors: Goveia
authors: Mark J
authors: MJ
authors: DiNubile
authors: Penny M
authors: PM
authors: Heaton
authors: Max
authors: M
authors: Ciarlet
mesh_terms: D005759:Gastroenteritis / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects / Q000379:methods*; D007223:Infant; D010919:Placebos / Q000008:administration & dosage; D012400:Rotavirus Infections / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects / Q000379:methods*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D010919:Placebos; C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated