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Efficacy, Immunogenicity, and Safety of Two Doses of a Tetravalent Rotavirus Vaccine RRV-TV in Ghana With the First Dose Administered During the Neonatal Period
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Efficacy, Immunogenicity, and Safety of Two Doses of a Tetravalent Rotavirus Vaccine RRV-TV in Ghana With the First Dose Administered During the Neonatal Period
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Efficacy, Immunogenicity, and Safety of Two Doses of a Tetravalent Rotavirus Vaccine RRV-TV in Ghana With the First Dose Administered During the Neonatal Period
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Journal Article
Efficacy, Immunogenicity, and Safety of Two Doses of a Tetravalent Rotavirus Vaccine RRV-TV in Ghana With the First Dose Administered During the Neonatal Period
2013
Overview
Background. Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age. This study examined RRV-TV for the prevention of rotavirus gastroenteritis (RV-GE) in Ghana, West Africa, with infants receiving the first dose during the neonatal period and the second before 60 days of age. Methods. In a double-blinded, randomized, placebo-controlled trial in Navrongo, Ghana, we recruited neonates to receive 2 doses of RRV-TV or placebo and followed them to age 12 months. Results. In the intention-to-treat population of 998 infants, we measured a vaccine efficacy of 63.1% against RV-GE of any severity associated with any of the 4 serotypes represented in the vaccine and 60.7% against RV-GE associated with any rotavirus serotype. Conclusions. RRV-TV in a 2-dose schedule with the first dose during the neonatal period is efficacious in preventing RV-GE in rural Ghana. Neonatal dosing results in early protection and may be the optimum schedule to avoid or significantly reduce intussusception, now reported to be associated in international settings with the 2 most widely marketed, licensed, live virus, oral rotavirus vaccines.
Publisher
Oxford University Press
Subject
/ Biological and medical sciences
/ Dosage
/ Female
/ Fundamental and applied biological sciences. Psychology
/ Gastroenteritis - immunology
/ Gastroenteritis - prevention & control
/ Ghana
/ Humans
/ Infant
/ Infants
/ Male
/ Placebos
/ Placebos - administration & dosage
/ Rotavirus Infections - immunology
/ Rotavirus Infections - prevention & control
/ Rotavirus Vaccines - administration & dosage
/ Rotavirus Vaccines - adverse effects
/ Rotavirus Vaccines - immunology
/ Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
/ Virology
/ VIRUSES
