Evidence map›Paper›PMID 27059353›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

A Preliminary Assessment of Rotavirus Vaccine Effectiveness in Zambia.

Laura K Beres, Jacqueline E Tate, Lungowe Njobvu, Bertha Chibwe, Cheryl Rudd, M Brad Guffey, Jeffrey S A Stringer, Umesh D Parashar, Roma Chilengi

Registry-linked trialAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03602053 (An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC® , ROTAVAC 5CM and Rotarix® in Healthy Zambian Infants), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03602053 phase2 / phase3completednot on this mapstarted 2019, after this paper: background citation

An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC® , ROTAVAC 5CM and Rotarix® in Healthy Zambian Infants

TypeinterventionalSponsorCentre for Infectious Disease Research in ZambiaRan2019 to 2019Enrolled450ConditionsDiarrhea, Diarrhea RotavirusArmsROTAVAC®, ROTAVAC 5D, Rotarix®
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Effectiveness of RotarixWellcome open research · 2020
    Pooled it
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  14. Review
  15. Effectiveness of Monovalent Rotavirus Vaccine Against Hospitalization With Acute Rotavirus Gastroenteritis in Kenyan Children.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Article
  16. Article
  17. Article
  18. Impact of Rotavirus Vaccine Introduction in Children Less Than 2 Years of Age Presenting for Medical Care With Diarrhea in Rural Matlab, Bangladesh.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Article
  19. Review
  20. Monovalent Rotavirus Vaccine Effectiveness Against Rotavirus Hospitalizations Among Children in Zimbabwe.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Laura K BeresCentre for Infectious Disease Research in Zambia, Lusaka Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Jacqueline E TateDivision of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
Lungowe NjobvuCentre for Infectious Disease Research in Zambia, Lusaka.
Bertha ChibweCentre for Infectious Disease Research in Zambia, Lusaka.
Cheryl RuddCentre for Infectious Disease Research in Zambia, Lusaka.
M Brad GuffeyCentre for Infectious Disease Research in Zambia, Lusaka.
Jeffrey S A StringerUniversity of North Carolina School of Medicine, Chapel Hill.
Umesh D ParasharDivision of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
Roma ChilengiCentre for Infectious Disease Research in Zambia, Lusaka.

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundDiarrhea is the third leading cause of child death in Zambia. Up to one-third of diarrhea cases resulting in hospitalization and/or death are caused by vaccine-preventable rotavirus. In January 2012, Zambia initiated a pilot introduction of the Rotarix live, oral rotavirus vaccine in all public health facilities in Lusaka Province.

methodsBetween July 2012 and October 2013, we conducted a case-control study at 6 public sector sites to estimate rotavirus vaccine effectiveness (VE) in age-eligible children presenting with diarrhea. We computed the odds of having received at least 1 dose of Rotarix among children whose stool was positive for rotavirus antigen (cases) and children whose stool was negative (controls). We adjusted the resulting odds ratio (OR) for patient age, calendar month of presentation, and clinical site, and expressed VE as (1 - adjusted OR) × 100.

resultsA total of 91 rotavirus-positive cases and 298 rotavirus-negative controls who had under-5 card-confirmed vaccination status and were ≥6 months of age were included in the case-control analysis. Among rotavirus-positive children who were age-eligible to be vaccinated, 20% were hospitalized. Against rotavirus diarrhea of all severity, the adjusted 2-dose VE was 26% (95% confidence interval [CI], -30% to 58%) among children ≥6 months of age. VE against hospitalized children ≥6 months of age was 56% (95% CI, -34% to 86%).

conclusionsWe observed a higher point estimate for VE against increased severity of illness compared with milder disease, but were not powered to detect a low level of VE against milder disease.

Indexed as

Antigens, ViralCase-Control StudiesChild, PreschoolDiarrheaFecesFemaleHospitalizationHumansImmunogenicity, VaccineInfantInfant, NewbornMaleOdds RatioRotavirusRotavirus InfectionsRotavirus VaccinesAntigens, ViralRIX4414 vaccineRotavirus VaccinesVaccines, Attenuatedimmunizationrotavirusrotavirus vaccinevaccine effectivenessZambia

Identifiers

PMID27059353
PMCPMC11976676

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.