Dataset Information

Rotavirus vaccine and diarrhea mortality: quantifying regional variation in effect size.

ABSTRACT:

Background

Diarrhea mortality remains a leading cause of child death and rotavirus vaccine an effective tool for preventing severe rotavirus diarrhea. New data suggest vaccine efficacy may vary by region.

Methods

We reviewed published vaccine efficacy trials to estimate a regional-specific effect of vaccine efficacy on severe rotavirus diarrhea and hospitalizations. We assessed the quality of evidence using a standard protocol and conducted meta-analyses where more than 1 data point was available.

Results

Rotavirus vaccine prevented severe rotavirus episodes in all regions; 81% of episodes in Latin America, 42.7% of episodes in high-mortality Asia, 50% of episodes in sub-Saharan Africa, 88% of episodes low-mortality Asia and North Africa, and 91% of episodes in developed countries. The effect sizes observed for preventing severe rotavirus diarrhea will be used in LiST as the effect size for rotavirus vaccine on rotavirus-specific diarrhea mortality.

Conclusions

Vaccine trials have not measured the effect of vaccine on diarrhea mortality. The overall quality of the evidence and consistency observed across studies suggests that estimating mortality based on a severe morbidity reduction is highly plausible.

SUBMITTER: Fischer Walker CL

PROVIDER: S-EPMC3231889 | biostudies-literature | 2011 Apr

REPOSITORIES: biostudies-literature

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Publications

Rotavirus vaccine and diarrhea mortality: quantifying regional variation in effect size.

Fischer Walker Christa L CL Black Robert E RE

BMC public health 20110413

<h4>Background</h4>Diarrhea mortality remains a leading cause of child death and rotavirus vaccine an effective tool for preventing severe rotavirus diarrhea. New data suggest vaccine efficacy may vary by region.<h4>Methods</h4>We reviewed published vaccine efficacy trials to estimate a regional-specific effect of vaccine efficacy on severe rotavirus diarrhea and hospitalizations. We assessed the quality of evidence using a standard protocol and conducted meta-analyses where more than 1 data poi ...[more]

PMID: 21501433

Similar Datasets

Project description:BackgroundRotavirus is the most common cause of severe gastroenteritis among young children worldwide. Data are needed to assess the efficacy of the rotavirus vaccine in African children.MethodsWe conducted a randomized, placebo-controlled, multicenter trial in South Africa (3166 infants; 64.1% of the total) and Malawi (1773 infants; 35.9% of the total) to evaluate the efficacy of a live, oral rotavirus vaccine in preventing severe rotavirus gastroenteritis. Healthy infants were randomly assigned in a 1:1:1 ratio to receive two doses of vaccine (in addition to one dose of placebo) or three doses of vaccine - the pooled vaccine group - or three doses of placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were graded with the use of the Vesikari scale.ResultsA total of 4939 infants were enrolled and randomly assigned to one of the three groups; 1647 infants received two doses of the vaccine, 1651 infants received three doses of the vaccine, and 1641 received placebo. Of the 4417 infants included in the per-protocol efficacy analysis, severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group and in 1.9% of those in the pooled vaccine group (vaccine efficacy, 61.2%; 95% confidence interval, 44.0 to 73.2). Vaccine efficacy was lower in Malawi than in South Africa (49.4% vs. 76.9%); however, the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa (6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year). Efficacy against all-cause severe gastroenteritis was 30.2%. At least one serious adverse event was reported in 9.7% of the infants in the pooled vaccine group and in 11.5% of the infants in the placebo group.ConclusionsHuman rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life. (ClinicalTrials.gov number, NCT00241644.).

Dataset Information

Rotavirus vaccine and diarrhea mortality: quantifying regional variation in effect size.

Background

Methods

Results

Conclusions

Publications

Rotavirus vaccine and diarrhea mortality: quantifying regional variation in effect size.

Similar Datasets

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