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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.
Objectives:
- To assess the effectiveness of full (3 doses) and partial (1 and 2 doses) immunization with RV5;
- 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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