22505 Effectiveness and Duration of Protection of Pentavalent Rotavirus Vaccine at a Large, Urban US Pediatric Hospital

Monday, April 19, 2010: 11:05 AM
International Ballroom South

Background: Pentavalent rotavirus vaccine (RV5) was 98% efficacious against severe rotavirus gastroenteritis in pre-licensure studies.  Post-licensure assessments report similar effectiveness in the first year of life among US infants, but the effectiveness of RV5 in older children has not been well assessed.


  1. To  assess the effectiveness of full (3 doses) and partial (1 and 2 doses) immunization with RV5;
  2. To assess the duration of protection of a full 3-dose series of RV5.

Methods: A case-control assessment was conducted during February-June, 2008 and March-June, 2009 at Texas Children's Hospital.  Children age-eligible to have received RV5 (15 days-23 months of age [n=400] in 2008 and 15 days-35 months of age [n=286] in 2009) with symptoms of acute gastroenteritis (AGE; ≥1 episode of vomiting and/or ≥3 loose stools) were enrolled. Fecal specimens (n=365) were collected and tested for rotavirus.  Vaccine effectiveness (VE=[1-odds of vaccination]*100) was calculated using 2 control groups: rotavirus-negative AGE patients and patients with acute respiratory infections (ARI). To assess duration of protection, age at presentation was dichotomized into 2 categories: 6-11 months and ≥12 months.

Results: Overall effectiveness of a full series of RV5 was 83% (95% CI: 66%, 91%) and 86% (72%, 93%) using rotavirus-negative AGE and ARI controls, respectively, while effectiveness of 1 or 2 doses was 81% (54%, 92%) and 84% (56%, 94%), respectively, for both control groups combined.  Among children 6-11 months of age, a full RV5 series was 93% (69%, 98%) and 92% (62%, 98%) effective using rotavirus-negative AGE and ARI controls, respectively.  Among children ≥12 months of age, a full series of RV5 was 78% (51%, 90%) and 84% (64%, 93%) effective for each control group.

Conclusions: A full series of RV5 provides sustained protection against severe rotavirus disease through two years of life in US children.

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