Vaccines for preventing rotavirus diarrhoea: vaccines in use.
BACKGROUND
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.


OBJECTIVE
To evaluate rotavirus vaccines approved for use (Rotarix, RotaTeq, and Lanzhou Lamb Rotavirus (LLR)) for preventing rotavirus diarrhoea.


METHODS
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.


METHODS
Randomized controlled trials comparing rotavirus vaccines approved for use with placebo, no intervention, or another vaccine in children.


METHODS
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).


RESULTS
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.


CONCLUSIONS
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.
Soares-Weiser
Karla
K
Enhance Reviews Ltd, 5 Percy Street, Office 4, London, UK, W1T 1DG.
Maclehose
Harriet
H
Ben-Aharon
Irit
I
Goldberg
Elad
E
Pitan
Femi
F
Cunliffe
Nigel
N
D002675:Child, Preschool; D003967:Diarrhea / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016032:Randomized Controlled Trials as Topic; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000627:therapeutic use*; D014613:Vaccines, Attenuated / Q000627:therapeutic use
C492457:RIX4414 vaccine; C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated