Elsevier

Vaccine

Volume 30, Issue 3, 11 January 2012, Pages 539-543
Vaccine

Effectiveness of rotavirus vaccines in preventing cases and hospitalizations due to rotavirus gastroenteritis in Navarre, Spain

https://doi.org/10.1016/j.vaccine.2011.11.071Get rights and content

Abstract

Two rotavirus vaccines have been available since 2006. This study evaluates the effectiveness of these vaccines using a test-negative case–control design in Navarre, Spain. We included children 3–59 months of age who sought medical care for gastroenteritis and for whom stool samples were taken between January 2008 and June 2011. About 9% had received the pentavalent vaccine (RotaTeq) and another 8% received the monovalent vaccine (Rotarix). Cases were the 756 children with confirmed rotavirus and controls were the 6036 children who tested negative for rotavirus. Thirty-five percent of cases and 9% of controls had required hospitalization (p < 0.0001). The adjusted effectiveness of complete vaccination was 78% (95% CI: 68–85%) in preventing rotavirus gastroenteritis and 83% (95% CI: 65–93%) in preventing hospitalization for rotavirus gastroenteritis. No differences between the two vaccines were detected (p = 0.4523). Both vaccines were highly effective in preventing cases and hospital admissions in children due to rotavirus gastroenteritis.

Highlights

► Two rotavirus vaccines with proven efficacy have been available since 2006. ► In this study, vaccination was 78% effective in preventing rotavirus gastroenteritis. ► The effectiveness of complete vaccination was 83% against hospitalization for rotavirus gastroenteritis. ► No differences were detected between the two vaccine brands.

Introduction

Rotavirus is the most common cause of acute gastroenteritis in children worldwide. It has been estimated that by the age of 5 years, nearly every child has been infected with rotavirus at least once [1], [2]. Before the availability of a vaccine, rotavirus was responsible for over 40% of hospital admissions for gastroenteritis in children [3], [4], [5], [6]. In Spain, it has been estimated that before the vaccine became available rotavirus annually caused 480 admissions for every 100,000 children under 5 years of age [7].

In 2006, two oral live-attenuated rotavirus vaccines were licensed for infants up to 6 months of life, a monovalent human rotavirus vaccine (RV1, Rotarix, GlaxoSmithKline Biologicals, Rixensart, Belgium) and a pentavalent bovine-human reassortant vaccine (RV5, RotaTeq, Merck Vaccines, Whitehouse Station, NJ, USA). Clinical trials of the two licensed vaccines show high efficacy against the serotypes included in the respective vaccines [8], [9].

Rotavirus vaccination was first recommended to US children in February 2006 [10]. Subsequently, in April 2009, the World Health Organization Strategic Advisory Group of Experts recommended rotavirus vaccine for all children [11]. Worldwide, a number of countries have adopted this recommendation and have added rotavirus vaccines to their pediatric immunization programs, including a limited number of European countries (Finland, Austria, Luxembourg and Belgium) [12], [13], [14]. In some of these countries, systematic vaccination has resulted in marked reductions in the incidence of rotavirus gastroenteritis and in hospitalizations for this cause [10], [13], [14], [15], [16]. In evaluations of these vaccines in the population under real-life conditions, most studies have found them to be highly effective [17], [18], [19], [20], [21], [22], although no evidence of a protective effect was found in an outbreak of a heterotypic strain in Australia [23].

In Spain, RV1 and RV5 have been available since 2006. They are not included in the official schedule of childhood vaccines funded by the health administration, but many pediatricians recommend them and parents can have their children vaccinated if they pay the cost of the vaccine. The two vaccines have been used equally, with the choice between them influenced by the recommendation of the physician or pharmacist, the cost of each regimen, the parents’ decision and their availability at the time of use. The Spanish Medicines Agency has provisionally suspended the marketing of RV1 since March 2010, and also of RV5 between July and August 2010, due to contamination detected in each of these vaccines [24], [25]. As of October 2011 use of RV1 continued to be suspended.

The objective of the present study was to evaluate the effectiveness of rotavirus vaccination in children 3–59 months of age in preventing cases of virologically confirmed gastroenteritis and in preventing hospital admissions due to this cause.

Section snippets

Study population and data collection

We carried out a case–control study based on electronic clinical reports in the region of Navarre, Spain (630,000 inhabitants, including 34,000 children < 5 years). The Navarre Ethical Committee for Medical Research approved the study protocol.

The Navarre Health Service provides health care, free at point of service, to 97% of the population; it comprises one tertiary hospital in the main city, two small local hospitals – all of them with pediatric wards and emergency rooms – and 54 primary

Characteristics of the study population

A total of 6792 children met the inclusion criteria, 756 (11%) of whom were confirmed for rotavirus (cases) and 6036 were negative (controls). Cases and controls did not differ with regard to distribution by sex, rural/urban residence, migrant status or pre-existing major chronic conditions. About 41% of cases were under 12 months of age versus 25% of controls (p < 0.0001). Cases showed marked seasonality, preferentially for the first semester of the year, whereas seasonal variation was less

Discussion

Both of the available rotavirus vaccines showed high effectiveness in preventing confirmed cases of rotavirus gastroenteritis in children aged 3–59 months as well as in preventing hospital admissions with this diagnosis. Our estimates of effectiveness are slightly lower than those observed in clinical trials [8], [9] and are within the range of those described in observational studies [17], [18], [19], [20], [21], [22]. Unlike other studies, we evaluated both the available vaccines, covering a

Conclusions

The monovalent and pentavalent rotavirus vaccines have high levels of effectiveness in preventing both rotavirus gastroenteritis and hospitalizations for this cause. In small geographic areas the effectiveness may vary over time, which could explain some disparity in the results of different studies. We did not detect any important differences in effectiveness between the two brands of vaccine available.

Acknowledgement

This work was supported in part by the Rotavirus Programme funded by the European Centre for Disease Prevention and Control (ECDC).

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