Article Text

  1. T Vesikari1,
  2. P Dennehy2,
  3. D Matson3,
  4. R Itzler4,
  5. M Dallas4,
  6. M Goveia4,
  7. M DiNubile4,
  8. P Heaton5,
  9. J Lawrence4,
  10. M Ciarlet4
  1. 1University of Tampere, Medical School, Tampere, Finland
  2. 2Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA
  3. 3Eastern Virginia Medical School and Old Dominion University, Norfolk, Virginia, USA
  4. 4Merck & Co., Inc., North Wales, Pennsylvania, USA
  5. 5Novavac, Rockville, Maryland, USA (current affiliation)


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.


Vesikari, Dennehy et al

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.

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