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Vaccines for preventing rotavirus diarrhoea: vaccines in use.
Cochrane Database Syst Rev 2010; (5):CD008521CD

Abstract

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.

OBJECTIVES

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

SEARCH STRATEGY

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.

SELECTION CRITERIA

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).

MAIN 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.

AUTHORS' 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.

Authors+Show Affiliations

Enhance Reviews Ltd, 5 Percy Street, Office 4, London, UK, W1T 1DG.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Review
Systematic Review

Language

eng

PubMed ID

20464766

Citation

Soares-Weiser, Karla, et al. "Vaccines for Preventing Rotavirus Diarrhoea: Vaccines in Use." The Cochrane Database of Systematic Reviews, 2010, p. CD008521.
Soares-Weiser K, Maclehose H, Ben-Aharon I, et al. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev. 2010.
Soares-Weiser, K., Maclehose, H., Ben-Aharon, I., Goldberg, E., Pitan, F., & Cunliffe, N. (2010). Vaccines for preventing rotavirus diarrhoea: vaccines in use. The Cochrane Database of Systematic Reviews, (5), p. CD008521. doi:10.1002/14651858.CD008521.
Soares-Weiser K, et al. Vaccines for Preventing Rotavirus Diarrhoea: Vaccines in Use. Cochrane Database Syst Rev. 2010 May 12;(5)CD008521. PubMed PMID: 20464766.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vaccines for preventing rotavirus diarrhoea: vaccines in use. AU - Soares-Weiser,Karla, AU - Maclehose,Harriet, AU - Ben-Aharon,Irit, AU - Goldberg,Elad, AU - Pitan,Femi, AU - Cunliffe,Nigel, Y1 - 2010/05/12/ PY - 2010/5/14/entrez PY - 2010/5/14/pubmed PY - 2010/6/17/medline SP - CD008521 EP - CD008521 JF - The Cochrane database of systematic reviews JO - Cochrane Database Syst Rev IS - 5 N2 - 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. OBJECTIVES: To evaluate rotavirus vaccines approved for use (Rotarix, RotaTeq, and Lanzhou Lamb Rotavirus (LLR)) for preventing rotavirus diarrhoea. SEARCH STRATEGY: 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. SELECTION CRITERIA: 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). MAIN 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. AUTHORS' 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. SN - 1469-493X UR - https://www.unboundmedicine.com/medline/citation/20464766/Vaccines_for_preventing_rotavirus_diarrhoea:_vaccines_in_use_ L2 - https://doi.org/10.1002/14651858.CD008521 DB - PRIME DP - Unbound Medicine ER -