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Pentavalent rotavirus vaccine in developing countries: safety and health care resource utilization.
- Source :
-
Pediatrics [Pediatrics] 2010 Dec; Vol. 126 (6), pp. e1499-506. Date of Electronic Publication: 2010 Nov 29. - Publication Year :
- 2010
-
Abstract
- 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.<br />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.<br />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.<br />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.
- Subjects :
- Developing Countries
Female
Follow-Up Studies
Hospitalization statistics & numerical data
Humans
Infant
Jamaica epidemiology
Male
Retrospective Studies
Rotavirus Infections epidemiology
Rotavirus Infections immunology
Treatment Outcome
Vaccines, Attenuated administration & dosage
Delivery of Health Care statistics & numerical data
Rotavirus immunology
Rotavirus Infections prevention & control
Rotavirus Vaccines administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1098-4275
- Volume :
- 126
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Pediatrics
- Publication Type :
- Academic Journal
- Accession number :
- 21115586
- Full Text :
- https://doi.org/10.1542/peds.2010-1240