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Determining the Post-Licensure Effectiveness of Pentavalent Rotavirus Vaccine using Observational Study Designs
Author Info
Donauer, Stephanie
Permalink:
http://rave.ohiolink.edu/etdc/view?acc_num=ucin1368026785
Abstract Details
Year and Degree
2013, PhD, University of Cincinnati, Medicine: Epidemiology (Environmental Health).
Abstract
The primary objective of this study is to determine the vaccine effectiveness (VE) of the pentavalent rotavirus vaccine (RV5) for preventing rotavirus-related hospitalizations and emergency department (ED) visits using two observational study designs. A secondary objective is to evaluate the VE of RV5 for preventing hospitalizations and ED visits due to rotavirus serotypes G1-G4, the serotypes contained in RV5. Active, prospective, population-based surveillance was conducted to identify cases of laboratory-confirmed rotavirus-related hospitalizations and ED visits. These cases were used in three separate types of VE analyses: two case-control designs and one case-cohort design. Case-cohort designs are able to accommodate time-changing covariates, such as vaccination status. The first case-control design used test-negative controls: those who presented to the same hospital or ED as the rotavirus-positive cases with symptoms of acute gastroenteritis (AGE), but were rotavirus-negative by laboratory confirmation. The second case-control design used controls who presented to the same hospital or ED as the cases with symptoms of acute respiratory infection (ARI). Two VE estimates were calculated using the case-control study designs, and one VE estimate was calculated using a case-cohort study design. VE estimates produced by each of the three analyses were similar. Three doses of RV5 were effective for preventing rotavirus-related hospitalizations and ED visits in all analyses, with VE estimated as 92% in each of the three analyses. Two doses of RV5 were also effective, with the three analyses producing similar VE estimates that ranged from 79% to 83%. A single dose was not significant in either of the case-control analyses, but was effective in the case-cohort analysis. The precise accounting of subjects’ vaccination status over time in the case-cohort design may explain the different point-estimates for a single dose produced by this design when compared to those produced by the case-control designs, which discard this temporal information. The secondary objective produced VE estimates for reducing hospitalizations and ED visits due to rotavirus serotypes G1-G4 similar to, but slightly lower, than the VE estimates against any rotavirus serotype produced by the primary objective. The P[8] serotype included in RV5 likely provided some protection against non-G1-G4 strains, which may explain why VE against any serotype was similar to VE against only the G1-G4 serotypes found in the vaccine. In conclusion, RV5 was found to be highly effective in preventing rotavirus-related hospitalizations and ED visits during two rotavirus seasons, and both the case-cohort and case-control study designs produced the same, valid VE estimates for a complete, three-dose vaccination course of RV5. If the major objective of a study is to determine the effectiveness of partial doses, a case-cohort design, which can more precisely account for a subjects’ changing vaccination status over time with a more sophisticated statistical model, may provide more accurate VE estimates for partial doses. To determine VE for a full, three-dose course of pentavalent rotavirus vaccine for preventing rotavirus-related hospitalizations and ED visits, a test-negative case-control design produces valid and reliable VE estimates, and is the least expensive and least time-consuming, making it the optimal choice.
Committee
Marepalli Rao, Ph.D. (Committee Chair)
Shelia Salisbury, Ph.D. (Committee Member)
Kim Dietrich, Ph.D. (Committee Member)
Mary Staat, M.D. (Committee Member)
Pages
205 p.
Subject Headings
Epidemiology
Keywords
rotavirus
;
vaccine effectiveness
;
study design
;
;
;
;
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Citations
Donauer, S. (2013).
Determining the Post-Licensure Effectiveness of Pentavalent Rotavirus Vaccine using Observational Study Designs
[Doctoral dissertation, University of Cincinnati]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1368026785
APA Style (7th edition)
Donauer, Stephanie.
Determining the Post-Licensure Effectiveness of Pentavalent Rotavirus Vaccine using Observational Study Designs.
2013. University of Cincinnati, Doctoral dissertation.
OhioLINK Electronic Theses and Dissertations Center
, http://rave.ohiolink.edu/etdc/view?acc_num=ucin1368026785.
MLA Style (8th edition)
Donauer, Stephanie. "Determining the Post-Licensure Effectiveness of Pentavalent Rotavirus Vaccine using Observational Study Designs." Doctoral dissertation, University of Cincinnati, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1368026785
Chicago Manual of Style (17th edition)
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Document number:
ucin1368026785
Download Count:
364
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© , all rights reserved.
This open access ETD is published by University of Cincinnati and OhioLINK.