Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa
dc.contributor.author | Tapia, M.D. | |
dc.contributor.author | Armah, G. | |
dc.contributor.author | Breiman, R.F. | |
dc.contributor.author | Dallas, M.J. | |
dc.contributor.author | Lewis, K.D.C. | |
dc.contributor.author | Sow, S.O. | |
dc.contributor.author | Rivers, S.B. | |
dc.contributor.author | Levine, M.M. | |
dc.contributor.author | Laserson, K.F. | |
dc.contributor.author | Feikin, D.R. | |
dc.contributor.author | Victor, J.C. | |
dc.contributor.author | Ciarlet, M. | |
dc.contributor.author | Neuzil, K.M. | |
dc.contributor.author | Steele, A.D. | |
dc.date.accessioned | 2019-01-17T12:59:33Z | |
dc.date.available | 2019-01-17T12:59:33Z | |
dc.date.issued | 2012-04 | |
dc.description.abstract | The efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq®, was evaluated in a double-blind, placebo-controlled, multicenter Phase III clinical trial conducted (April 2007-March 2009) in 3 low-income countries in Africa: Ghana, Kenya, and Mali. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age; concomitant administration with routine EPI vaccines, including OPV, was allowed. HIV-infected infants were not excluded. The primary endpoint, vaccine efficacy (VE) against severe-rotavirus gastroenteritis (RVGE), as measured by Vesikari scoring system (VSS, score ≥11), from ≥14 days following Dose 3 through a follow-up period of nearly 2 years in the combined 3 African countries, and secondary endpoints by total follow-up period have been previously reported. In this study, we report post hoc subgroup analyses on secondary endpoints of public health importance. VE against RVGE of any severity was 49.2% (95%CI: 29.9, 63.5) through the first year of life and 30.5% (95%CI: 16.7, 42.2) through the complete follow-up period. VE against severe-gastroenteritis of any etiology was 21.5% (95%CI: <0, 38.4) through the first year of life and 10.6% (95%CI: <0, 24.9) through the complete follow-up period. Through the complete follow-up period, VE against severe-RVGE caused by (i) vaccine-contained G and P types (G1-G4, P1A[8]), (ii) non-vaccine G types (G8, G9, G10), and (iii) non-vaccine P types (P1B[4], P2A[6]) was 34.0% (95%CI:11.2, 51.2), 81.8% (95%CI:16.5, 98.0) and 40.7% (95%CI:8.4, 62.1), respectively. There was a trend towards higher VE with higher disease severity, although in some cases the numbers were small. In African countries with high under-5 mortality rates, PRV significantly reduced RVGE through nearly 2 years of follow-up; more modest reductions were observed against gastroenteritis of any etiology. PRV provides protection against severe-RVGE caused by diverse rotavirus genotypes, including those not contained in the vaccine. © 2012 Elsevier Ltd. | en_US |
dc.identifier.other | Volume 30, Supplement 1, Pages A79-A85 | |
dc.identifier.other | https://doi.org/10.1016/j.vaccine.2012.01.022 | |
dc.identifier.uri | http://ugspace.ug.edu.gh/handle/123456789/26883 | |
dc.language.iso | en | en_US |
dc.publisher | Vaccine | en_US |
dc.subject | G genotype | en_US |
dc.subject | Gastroenteritis | en_US |
dc.subject | P genotype | en_US |
dc.subject | Rotavirus | en_US |
dc.subject | Vaccine efficacy | en_US |
dc.title | Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa | en_US |
dc.type | Article | en_US |
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