Pentavalent rotavirus vaccine in developing countries: safety and health care resource utilization.
OBJECTIVE
In the international, placebo-controlled, Rotavirus Efficacy and Safety Trial, the pentavalent rotavirus vaccine reduced the rate of rotavirus-attributable hospitalizations and emergency department visits by 95%. This study investigated the effect in Jamaica.


METHODS
The vaccine effect on rates of hospitalizations and emergency department visits in Jamaica was evaluated in both modified intention-to-treat and per-protocol analyses. Rates of serious adverse events, including intussusception, also were compared between groups.


RESULTS
A total of 1804 Jamaican infants, 6 to 12 weeks of age at entry and primarily from low/middle-income families of African heritage, received ≥1 dose. During the first year after dose 1, there were 2 and 11 hospitalizations or emergency department visits attributable to rotavirus gastroenteritis involving any serotype among 831 evaluable vaccine recipients and 809 evaluable placebo recipients, respectively (rate reduction: 82.2% [95% confidence interval: 15.1%-98.0%]). In the per-protocol analysis, all 8 G1 to G4 rotavirus-attributable events that occurred ≥2 weeks after dose 3 were in the placebo group (rate reduction: 100% [95% confidence interval: 40.9%-100%]). Of the 1802 subjects included in the safety analyses, intussusception was confirmed for 1 vaccine recipient (115 days after the third dose) and 3 placebo recipients. One vaccine recipient and 3 placebo recipients died during the follow-up period, but none of the deaths was considered to be vaccine-related.


CONCLUSIONS
In this posthoc subgroup analysis, the vaccine reduced health care resource utilization attributable to rotavirus gastroenteritis, without increased risk of intussusception or other serious adverse events, among infants in a resource-limited country.
Department of Pediatrics, University of the West Indies, Kingston, Jamaica. celia.christiesamuels@uwimona.edu.jm
Celia D C
CD
Christie
Newton D
ND
Duncan
Kirk A
KA
Thame
Matthew T
MT
Onorato
Hyacinth D
HD
Smith
Lavern G
LG
Malcolm
Robbin F
RF
Itzler
Mark J
MJ
Dinubile
Penny M
PM
Heaton
D003695:Delivery of Health Care / Q000706:statistics & numerical data*; D003906:Developing Countries; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007563:Jamaica / Q000453:epidemiology; D008297:Male; D012189:Retrospective Studies; D012401:Rotavirus / Q000276:immunology*; D012400:Rotavirus Infections / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage*; D016896:Treatment Outcome; D014613:Vaccines, Attenuated / Q000008:administration & dosage
C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated