Objectives: This retrospective observational study (NCT00875641) assesses the occurrence of several safety outcomes among recipients of RV1 compared to recipients of inactivated poliovirus vaccine (IPV) in concurrent and recent historical cohorts. We present results available to date for IS and all-cause mortality.
Methods: Using administrative claims data from 2 large US health insurers, infants receiving RV1 and IPV were identified during the first 5 years of RV1 availability. IPV recipients were frequency-matched to RV1 recipients in a 3:1 ratio by age at first vaccination, gender, calendar quarter and year of vaccination. Potential IS cases were identified in the claims and confirmed by medical record review. Deaths were identified in claims and via external linkage to the National Death Index. Outcomes were assessed within pre-specified risk windows (0-59 days) following the first 2 doses of vaccine. Incidence rates (IRs) were calculated per 1,000 person-months.
Results: A total of 57,931 infants in the RV1 cohort were identified and matched to 173,384 infants in the concurrent IPV cohort and 159,344 infants in the historical IPV cohort. The IR of medical record-confirmed IS during the 60 days following any vaccine dose was 0.021 (95% CI: 0.006 – 0.055) in the RV1 cohort and 0.022 (0.012 – 0.037) in the concurrent IPV cohort and 0.021 (0.010 – 0.037) in the historical IPV cohort. No cases of medical record-confirmed IS were observed in the first 7 days following and including RV1 vaccination. The IR of all-cause mortality following any dose was 0.048 (0.022 – 0.091) in the RV1 cohort, 0.035 (0.022 – 0.054) in the concurrent IPV cohort and 0.062 (0.043 – 0.087) in the historical IPV cohort.
Conclusion: No increase in the risk of medical record-confirmed IS and all-cause mortality was observed with RV1.
Funding: GlaxoSmithKline Biologicals SA
GSK Biologicals: Consultant , This study was funded by GSK Biologicals SA. The research contract established between Optum and GSK Biologicals SA granted Optum oversight of the study conduct, reporting, and interpretation, as well as final wording of any resulting manuscripts.
M. Doherty, United Health Group: Employee and Shareholder , Salary
S. C. Quinlan, HealthCore Inc.: Research Contractor , Research support
D. Esposito, HealthCore, Inc: Employee , Salary
K. Skerry, GSK: Research Contractor , This work was completed as part of a contract between Optum and GSK. I am an employee of Optum.
Optum: Employee , Salary
C. N. Holick, HealthCore, Inc: Research Contractor , Research support
H. Buyse, GSK Biologicals: Employee , Salary
R. Abu-Elyazeed, GSK: Employee and Shareholder , Salary
S. Wery, GSK: Consultant , Salary as CRO from Keyrus Biopharma
N. Praet, GSK Biologicals: Employee , Salary
D. D. Dore, GSK Biologicals: Research Contractor , Research support
C. Enger, GSK: Research Contractor , Research support