Rotavirus results in higher diarrhoea-related death in children less than five years of age than any other single agent, particularly in low- and middle-income countries. The World Health Organization has recommended the use of rotavirus vaccines in childhood immunization schedules.
To evaluate rotavirus vaccines approved for use (Rotarix, RotaTeq, and Lanzhou Lamb Rotavirus (LLR)) for preventing rotavirus diarrhoea.
In February 2010, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in The Cochrane Library 2009, Issue 1), MEDLINE, EMBASE, LILACS, and BIOSIS. We also searched the ICTRP (January 2010) and checked reference lists of identified studies.
Randomized controlled trials comparing rotavirus vaccines approved for use with placebo, no intervention, or another vaccine in children.
Data collection and analysis
Two authors independently assessed trial eligibility, extracted data, and assessed risk of bias. Dichotomous data were combined using the risk ratio (RR) and 95% confidence intervals (CI).
Thirty-four trials that included 175,944 participants met the inclusion criteria. They evaluated Rotarix (26 trials; 99,841 participants) and RotaTeq (eight trials; 76,103 participants), and had variable risk of bias (where information provided). None of the identified trials used LLR or compared rotavirus vaccines. Compared to placebo, Rotarix and RotaTeq were both effective at reducing rotavirus diarrhoea (severe cases and cases of any severity). They also reduced all-cause diarrhoea (severe cases), and hospitalizations and need for medical attention caused by rotavirus diarrhoea. However, few data were available for Rotarix and all-cause diarrhoea. Versus the placebo groups, participants in each vaccine group had similar numbers of deaths, serious adverse events, reactogenicity profiles (fever, diarrhoea, and vomiting), and adverse events that required discontinuation of the vaccination schedule. Both vaccines were immunogenic (measured by virus shedding in stool and/or seroconversion). Subgroup analyses indicate that both vaccines are effective in countries with different incomes, but few data are available.
Rotarix and RotaTeq are effective vaccines for the prevention of rotavirus diarrhoea. The balance between benefit and harm favours benefit. Ongoing safety monitoring should be continued. Trials comparing LLR with placebo should be conducted and the results made available.
Plain Language Summary
Vaccines for preventing rotavirus diarrhoea: vaccines in use
Rotavirus infection is the most common cause of diarrhoea in infants and young children, and the symptoms can range from non-severe illness, to hospitalization and death. Rotavirus infections cause over half a million deaths per year in children younger than five years, especially in low- and middle-income countries. Since 2009, the World Health Organization has recommended vaccination be included in national immunization programmes.
This review evaluates three vaccines currently in use: Rotarix and RotaTeq, which have been evaluated in several large trials and are approved for use in many countries; and Lanzhou Lamb Rotavirus vaccine (LLR), which is approved for use in China only.
The review includes 34 trials with about 175,944 participants; all trials compared a rotavirus vaccine with a placebo. The vaccines tested were Rotarix (26 trials with 99,841 participants) and RotaTeq (eight trials with 76,103 participants). None of the identified trials used LLR. The trials took place all over the world.
Compared to placebo, Rotarix and RotaTeq were both effective at reducing rotavirus diarrhoea. They also reduced severe diarrhoea from all causes, hospitalizations and need for medical attention. The vaccines were particularly effective at one and two years of follow-up. The vaccines tested against placebo gave similar numbers of adverse events such as deaths, reactions to the vaccine, and others that required discontinuation of the vaccination schedule.
In conclusion, data from this review show that Rotarix and RotaTeq are effective vaccines, and support the World Health Organization's recommendation to include rotavirus vaccination of infants into national immunization programmes, especially in countries with a high burden of diarrhoeal deaths in children younger than five years. New trials with head-to-head comparisons of both vaccines are needed, as well as trials comparing LLR with placebo, data for special groups of children, such as preterm infants and malnourished children, and extensive monitoring of adverse events where vaccines are routinely used.