Abstract:
BACKGROUND: Postlicensure studies have shown an association between rotavirus vaccination and intussusception. We assessed
the risk of intussusception associated with Rotarix (RV1) administration, at 6 and 14 weeks of age, in an upper-middle-income
country, South Africa.
METHODS: Active prospective surveillance for intussusception was conducted in 8 hospitals from September 2013 through
December 2017. Retrospective case enrollment was done at 1 hospital from July 2012 through August 2013. Demographic characteristics, symptom onset, and rotavirus vaccine status were ascertained. Using the self-controlled case-series method, we estimated
age-adjusted incidence rate ratios within 1–7, 8–21, and 1–21 days of rotavirus vaccination in children aged 28–275 days at onset of
symptoms. In addition, age-matched controls were enrolled for a subset of cases (n = 169), and a secondary analysis was performed.
RESULTS: Three hundred forty-six cases were included in the case-series analysis. Post–dose 1, there were zero intussusception
cases within 1–7 days, and 5 cases within 8–21 days of vaccination. Post–dose 2, 15 cases occurred within 1–7 days, and 18 cases
within 8–21 days of vaccination. There was no increased risk of intussusception 1–7 days after dose 1 (no cases observed) or dose 2
(relative incidence [RI], 1.71 [95% confidence interval {CI} .83–3.01]). Similarly, there was no increased risk 8–21 days after the first
(RI, 4.01 [95% CI, .87–10.56]) or second dose (RI, .96 [95% CI, .52–1.60]). Results were similar for the case-control analysis.
CONCLUSIONS: The risk of intussusception in the 21 days after the first or second dose of RV1 was not higher than the background
risk among South Africa infants.
Description:
Presented in part: 13th International Rotavirus Symposium, Minsk, Belarus, 29‒31
August 2018.
