The rotavirus vaccines RotaTeq(R) (Rotavirus Vaccine, live, oral, pentavalent) [RV5] (Merck &Co., Inc.) and Rotarix(R) (Rotavirus Vaccine, live, oral) [RV1] (GlaxoSmithKline Biologicals) are recommended for routine use among U.S. infants by the Advisory Committee on Immunization Practices (ACIP). Recent observational studies suggest that rotavirus vaccines dramatically reduce hospitalizations and emergency department visits among young children in the U.S.;however, there are currently no large-scale studies comparing the effectiveness and safety of RV5 and RV1. We propose to compare the effectiveness and safety of RV5 and RV1 in a population of over 700,000 infants in the U.S. who were covered by private insurance or Medicaid insurance from 2006-2011.The large size of our study will allow us to characterize small differences between the two rotavirus vaccines with regards to effectiveness, which may differ as RV5 requires three administrations versus two for RV1. Our novel self-controlled design and data-driven vaccine surveillance methods will help us further characterize the potential risks linked to rotavirus vaccination intussusception as well as identify other potential conditions of concern. In addition to comparative effectiveness and safety analyses, we will study coverage patterns of both vaccines, including geographic disparities and differences in completion of the rotavirus vaccination series. We will further determine individual, provider, and ecological predictors of rotavirus vaccine uptake. Our research will be conducted with guidance from a panel of experts and stakeholders from the University of North Carolina at Chapel Hill, Harvard School of Public Health, and the Center Biologics Evaluation and Research at the U.S. Food and Drug Administration (FDA). The results of our research will help inform potential quality improvement initiatives by identifying predictors of rotavirus vaccine uptake and will provide clinicians, payors, regulators, and policy makers with timely information on the relative benefits and harms of RV5 versus RV1. The study will also contribute to the development of modern statistical methods and study designs that can be used to study of benefits and risks associated with childhood vaccines.

Public Health Relevance

The comparative effectiveness and safety of RV5 versus RV1 has not been established in U.S. infants, and patterns of use of the vaccines have not been described. Using healthcare data from over 700,000 infants with private insurance or Medicaid, we will examine patterns of use, comparative effectiveness and safety of the rotavirus vaccines. We will also examine effectiveness and safety of the vaccines in various subgroups, including infants who reside in rural geographies, failed to complete the vaccine series, or received the vaccine on an alternative schedule. The results of our research will help inform potential quality improvement initiatives by identifying predictors of rotavirus vaccine uptake and will provide clinicians, payors, regulators, and policy makers with timely information on the relative benefits and harms of RV5 versus RV1.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Exploratory/Developmental Grants (R21)
Project #
Application #
Study Section
Infectious Diseases, Reproductive Health, Asthma and Pulmonary Conditions Study Section (IRAP)
Program Officer
Grave, Gilman D
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of North Carolina Chapel Hill
Public Health & Prev Medicine
Schools of Public Health
Chapel Hill
United States
Zip Code
Bushnell, Greta A; Brookhart, M Alan; Gaynes, Bradley N et al. (2018) Examining Parental Medication Adherence as a Predictor of Child Medication Adherence in Pediatric Anxiety Disorders. Med Care 56:510-519
Layton, J Bradley; Butler, Anne M; Panozzo, Catherine A et al. (2018) Rotavirus vaccination and short-term risk of adverse events in US infants. Paediatr Perinat Epidemiol 32:448-457
Li, Xiaojuan; Cole, Stephen R; Westreich, Daniel et al. (2018) Primary non-adherence and the new-user design. Pharmacoepidemiol Drug Saf 27:361-364
Hong, Jin-Liern; Buse, John B; Jonsson Funk, Michele et al. (2018) The Risk of Acute Pancreatitis After Initiation of Dipeptidyl Peptidase 4 Inhibitors: Testing a Hypothesis of Subgroup Differences in Older U.S. Adults. Diabetes Care 41:1196-1203
Gruber, J F; Becker-Dreps, S; Hudgens, M G et al. (2018) Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries. Epidemiol Infect 146:698-704
Wang, Tiansheng; Hong, Jin-Liern; Gower, Emily W et al. (2018) Incretin-Based Therapies and Diabetic Retinopathy: Real-World Evidence in Older U.S. Adults. Diabetes Care 41:1998-2009
Gruber, Joann F; Becker-Dreps, Sylvia; Hudgens, Michael G et al. (2018) Timing of Rotavirus Vaccine Doses and Severe Rotavirus Gastroenteritis Among Vaccinated Infants in Low- and Middle-income Countries. Epidemiology 29:867-875
Cuthbertson, Carmen C; Kucharska-Newton, Anna; Faurot, Keturah R et al. (2018) Controlling for Frailty in Pharmacoepidemiologic Studies of Older Adults: Validation of an Existing Medicare Claims-based Algorithm. Epidemiology 29:556-561
Bush, Montika; Simpson Jr, Ross J; Kucharska-Newton, Anna et al. (2018) Approaches to Address Premature Death of Patients When Assessing Patterns of Use of Health Care Services After an Index Event. Med Care 56:619-625
Hong, Jin-Liern; Jonsson Funk, Michele; LoCasale, Robert et al. (2018) Generalizing Randomized Clinical Trial Results: Implementation and Challenges Related to Missing Data in the Target Population. Am J Epidemiol 187:817-827

Showing the most recent 10 out of 36 publications