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Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST) evaluating the human-bovine (WC3) reassortant pentavalent rotavirus vaccine (RV5).
BMC Pediatr. 2010 Jun 11; 10:42.BPed

Abstract

BACKGROUND

The Rotavirus Efficacy and Safety Trial was a placebo-controlled Phase III study that evaluated the safety and efficacy of a three-dose pentavalent rotavirus vaccine (RV5) including its effect on healthcare utilization for rotavirus gastroenteritis (RVGE). The per-protocol (PP) analyses, which counted events occurring 14 days after dose 3 among infants without protocol violations, have already been published. This paper evaluates the consistency of the healthcare utilization results based on the modified intention to treat (MITT) analyses with the PP analyses. The MITT analyses include all infants receiving at least one dose of vaccine or placebo and follow-up begins after dose 1. The paper also explores the consistency of the results for different subgroups of the study population with different types of surveillance.

METHODS

Data on healthcare utilization for acute gastroenteritis were collected via telephone interviews after administration of the first dose. Parents were either contacted every 6 weeks or every 2 weeks depending on the substudy in which they were enrolled. Those contacted every 2 weeks were also asked to complete symptom diaries. Poisson regression was used to evaluate the effect of RV5 on the rates of RVGE-associated healthcare encounters in all of the analyses.

RESULTS

In the first 2 years after vaccination, RV5 reduced the combined rate of hospitalizations and emergency department (ED) visits 88.9% (95% CI: 84.9, 91.9) for all RVGE regardless of serotype in the MITT analysis compared with a 94.5% (95% CI: 91.2, 96.6) reduction based on the G1-G4 PP analysis. By type of surveillance, the rate reductions for the G1-G4 PP analysis were 91.0% (95% CI: 81.7, 95.5) and 95.9% (95% CI: 92.2, 97.8) among parents contacted every 2 weeks (number evaluable = 4,451) and every 6 weeks (number evaluable = 52,683) respectively.

CONCLUSIONS

Our analyses demonstrated that the effect of RV5 on reducing the rate of hospitalizations and ED visits based on the MITT analyses were generally consistent with the PP analyses. The rate of events for subgroups with different intensities of surveillance differed but the effect of RV5 on the relative rate reductions were consistent with the results that have already been published.

TRIAL REGISTRATION

ClinicalTrials.gov number, NCT00090233.

Authors+Show Affiliations

Merck Research Laboratories, West Point, Pennsylvania, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20540778

Citation

Itzler, Robbin, et al. "Robustness of the Healthcare Utilization Results From the Rotavirus Efficacy and Safety Trial (REST) Evaluating the Human-bovine (WC3) Reassortant Pentavalent Rotavirus Vaccine (RV5)." BMC Pediatrics, vol. 10, 2010, p. 42.
Itzler R, Koch G, Matson DO, et al. Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST) evaluating the human-bovine (WC3) reassortant pentavalent rotavirus vaccine (RV5). BMC Pediatr. 2010;10:42.
Itzler, R., Koch, G., Matson, D. O., Gothefors, L., Van Damme, P., Dinubile, M. J., & Heaton, P. M. (2010). Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST) evaluating the human-bovine (WC3) reassortant pentavalent rotavirus vaccine (RV5). BMC Pediatrics, 10, 42. https://doi.org/10.1186/1471-2431-10-42
Itzler R, et al. Robustness of the Healthcare Utilization Results From the Rotavirus Efficacy and Safety Trial (REST) Evaluating the Human-bovine (WC3) Reassortant Pentavalent Rotavirus Vaccine (RV5). BMC Pediatr. 2010 Jun 11;10:42. PubMed PMID: 20540778.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST) evaluating the human-bovine (WC3) reassortant pentavalent rotavirus vaccine (RV5). AU - Itzler,Robbin, AU - Koch,Gary, AU - Matson,David O, AU - Gothefors,Leif, AU - Van Damme,Pierre, AU - Dinubile,Mark J, AU - Heaton,Penny M, Y1 - 2010/06/11/ PY - 2009/11/09/received PY - 2010/06/11/accepted PY - 2010/6/15/entrez PY - 2010/6/15/pubmed PY - 2010/10/20/medline SP - 42 EP - 42 JF - BMC pediatrics JO - BMC Pediatr VL - 10 N2 - BACKGROUND: The Rotavirus Efficacy and Safety Trial was a placebo-controlled Phase III study that evaluated the safety and efficacy of a three-dose pentavalent rotavirus vaccine (RV5) including its effect on healthcare utilization for rotavirus gastroenteritis (RVGE). The per-protocol (PP) analyses, which counted events occurring 14 days after dose 3 among infants without protocol violations, have already been published. This paper evaluates the consistency of the healthcare utilization results based on the modified intention to treat (MITT) analyses with the PP analyses. The MITT analyses include all infants receiving at least one dose of vaccine or placebo and follow-up begins after dose 1. The paper also explores the consistency of the results for different subgroups of the study population with different types of surveillance. METHODS: Data on healthcare utilization for acute gastroenteritis were collected via telephone interviews after administration of the first dose. Parents were either contacted every 6 weeks or every 2 weeks depending on the substudy in which they were enrolled. Those contacted every 2 weeks were also asked to complete symptom diaries. Poisson regression was used to evaluate the effect of RV5 on the rates of RVGE-associated healthcare encounters in all of the analyses. RESULTS: In the first 2 years after vaccination, RV5 reduced the combined rate of hospitalizations and emergency department (ED) visits 88.9% (95% CI: 84.9, 91.9) for all RVGE regardless of serotype in the MITT analysis compared with a 94.5% (95% CI: 91.2, 96.6) reduction based on the G1-G4 PP analysis. By type of surveillance, the rate reductions for the G1-G4 PP analysis were 91.0% (95% CI: 81.7, 95.5) and 95.9% (95% CI: 92.2, 97.8) among parents contacted every 2 weeks (number evaluable = 4,451) and every 6 weeks (number evaluable = 52,683) respectively. CONCLUSIONS: Our analyses demonstrated that the effect of RV5 on reducing the rate of hospitalizations and ED visits based on the MITT analyses were generally consistent with the PP analyses. The rate of events for subgroups with different intensities of surveillance differed but the effect of RV5 on the relative rate reductions were consistent with the results that have already been published. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT00090233. SN - 1471-2431 UR - https://www.unboundmedicine.com/medline/citation/20540778/Robustness_of_the_healthcare_utilization_results_from_the_Rotavirus_Efficacy_and_Safety_Trial__REST__evaluating_the_human_bovine__WC3__reassortant_pentavalent_rotavirus_vaccine__RV5__ L2 - https://bmcpediatr.biomedcentral.com/articles/10.1186/1471-2431-10-42 DB - PRIME DP - Unbound Medicine ER -