Objective The Rotavirus Efficacy & Safety Trial (REST) demonstrated that 3 doses of RotaTeq significantly reduced the per-protocol rate of healthcare encounters (HCE), defined as hospitalizations and emergency department (ED) visits for rotavirus gastroenteritis (RVGE), measured ⩾14 days postdose (PD) 3, by 95% (95% CI: 91 to 97). The objective here was to evaluate if RotaTeq confers early protection to infants before completion of the 3-dose regimen.
Methods ∼70,000 healthy 6–12 week-old infants were randomized to receive 3 doses of RotaTeq or placebo at 4–10 week intervals. RVGE was defined as forceful vomiting and/or ⩾3 watery or looser-than-normal stool within a 24-hour period and detection of rotavirus antigen by ELISA. Among ∼59,000 evaluable subjects, the HCE rate reduction between doses for G1-G4 RVGE, or any serotype RVGE, was evaluated using the exact binomial method for ratios of Poisson counts in several post-hoc analyses of REST. In all analyzes between Dose 1 to Dose 2, case counting started 14 days PD1 to allow time for an immune response to develop after the first dose.
Results See table.
Post-hoc analyses of REST indicate that RotaTeq provides consistently high protection against RVGE-attributable hospitalizations and ED visits between doses, starting ⩾14 days PD1. RotaTeq’s early protection against severe RGE may be beneficial to infants vaccinated during rotavirus epidemic seasons.