Efficacy of the pentavalent rotavirus vaccine, RotaTeq®, in Finnish infants up to 3 years of age: the Finnish Extension Study

Abstract

Rotavirus Efficacy and Safety Trial (REST) enrolled nearly 70,000 infants, of whom more than 23,000 were from Finland. REST determined the efficacy of the pentavalent rotavirus vaccine (RV5) against rotavirus-related hospitalisations and emergency department (ED) visits in the first year after vaccination. Finnish infants initially in REST transitioned into the Finnish Extension Study (FES), where they were followed for rotavirus-related hospitalisations and ED visits through their second year of life and beyond. FES identified 150 (31%) additional rotavirus gastroenteritis (RVGE) cases beyond those identified in REST in the Finnish participants. Overall, RV5 reduced RVGE hospitalisations and ED visits, regardless of the rotavirus serotype, by 93.8% (95% confidence interval [CI]: 90.8–95.9%) for up to 3.1 years following the last vaccine dose. Vaccine efficacy against combined hospitalisations and ED visits between ages 4 months to 11 months, 12 months to 23 months, and 24 months to 35 months was 93.9% (95% CI: 89.1–96.9%), 94.4% (95% CI: 90.2–97.0%), and 85.9% (95% CI: 51.6–97.2%), respectively. The reduction of hospitalisations and ED visits due to any acute gastroenteritis, rotavirus or not, was 62.4% (95% CI: 57.6–66.6%) over the entire follow-up period. The results from FES confirm that RV5 induces high and sustained protection against rotavirus-related hospitalisations and ED visits, and has a very substantial impact on all gastroenteritis-related hospitalisations and ED visits into the third year of life in Finnish children.

Long-term Consistency in Rotavirus Vaccine Protection: RV5 and RV1 Vaccine Effectiveness in US Children, 2012–2013

“…No statistical difference in VE was observed between fully vaccinated children in their second year of life from the published 2010-2011 study period and in their third year of life from our current 2012-2013 results, for either RV5 or RV1 (P = .848 and VE = P = .551, respectively). This finding is consistent with that of a prospective follow-up of Finnish Extension Study clinical trial participants showing significant reductions in rotavirus test-positive hospitalizations and ED visits for a period of at least 3.1 years following the last RV5 dose [25]. Comparing our 2012-2013 results from other similarly constructed studies [6][7][8]26] which analyzed VE for subjects enrolled from 2007 through 2011 (Figure 3), RV5 trends appear stable over time (VE range: 76%-89%, with mean annual variation = 4.2%).…”

Genetic Analyses Reveal Differences in the VP7 and VP4 Antigenic Epitopes between Human Rotaviruses Circulating in Belgium and Rotaviruses in Rotarix and RotaTeq

“…Human RVA SC-2 was isolated in 1981 at St. Christopher's Hospital of Philadelphia, and the WI79 and WI78 RVAs were isolated in 1983 at the Children's Hospital of Philadelphia, while the BrB (originally Bricout B) RVA strain was isolated in 1984 at L'Hôpital Armand Trousseau (Paris, France) (34). Both RVA vaccines have been proven to be safe and efficacious in large-scale clinical trials (9,51,59,61,62). The mechanisms by which the vaccines induce immunologic protection in infants have not been clearly elucidated.…”

“…The serotype-specific efficacy of both RVA vaccines against G1P [8] RVAs has been well established, predominantly because G1P [8] RVA strains were by far the most common circulating strains encountered during phase III clinical trials, which were conducted approximately 2 decades after the vaccine strains were isolated (51,(59)(60)(61)(62). However, little is known about the genetic characteristics of the RVA strains that circulated during the clinical trials, and how similar these strains, and their VP7 and VP4 components, were to the strains present in Rotarix and RotaTeq.…”

Rotaviral diarrhoea – why it is worth preventing

“…W 2009 i 2010 r. zmieniono rekomendacje dla obu szczepionek, jako że obserwowano przypadki nabycia poszczepiennej infekcji RV u dzieci z ciężkim kombinowanym niedoborem odporności -RV5 [76]. Tak więc u dzieci z takimi niedoborami obie szczepionki są przeciwwskazane [77].…”