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Determining the Post-Licensure Effectiveness of Pentavalent Rotavirus Vaccine using Observational Study Designs

Donauer, Stephanie

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2013, PhD, University of Cincinnati, Medicine: Epidemiology (Environmental Health).
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.
Marepalli Rao, Ph.D. (Committee Chair)
Shelia Salisbury, Ph.D. (Committee Member)
Kim Dietrich, Ph.D. (Committee Member)
Mary Staat, M.D. (Committee Member)
205 p.

Recommended Citations

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)