Efficacy, Immunogenicity, and Safety of a Pentavalent Human-Bovine (WC3) Reassortant Rotavirus Vaccine at the End of Shelf Life

Abstract

This pentavalent human-bovine rotavirus vaccine was generally well tolerated, efficacious, and immunogenic at the end of shelf life.

Projecting the effectiveness of RotaTeq® against rotavirus-related hospitalisations in Brazil

“…RV5 showed high and consistent efficacy in preventing RGE in randomised clinical trials that were previously conducted in countries with high standards of medical care (Vesikari et al 2006, Block et al 2007). In addition, recent effectiveness studies in the USA and Nicaragua showed that RV5 is effective in protecting against rotavirus-related hospitalisations , Boom et al 2010.…”

Options for improving effectiveness of rotavirus vaccines in developing countries

“…9 RV5 and RV1 have proven highly efficacious and effective in industrialised countries, providing at least 90% protection against severe rotavirus gastroenteritis and at least 74% protection against rotavirus gastroenteritis of any severity. [18][19][20][21][22][23][24] In contrast, studies conducted in low-income countries in Africa and Asia revealed that the efficacy of the 2 vaccines ranged from 56% to 64% in protecting against severe rotavirus gastroenteritis. [25][26][27][28][29][30] In addition, in these settings vaccine efficacy waned between the first and second years after immunisation.…”

Prevention of Rotavirus Disease: Updated Guidelines for Use of Rotavirus Vaccine

“…A 3% increase in the incidence of diarrhea and vomiting was observed with RV5, but these symptoms were mild and did not require treatment. 6,8,18 For RV1, no difference versus placebo was observed in the incidence of diarrhea, fever or severe fever, vomiting or severe vomiting, and irritability or severe irritability within 14 days of immunization with any dose. 9,10,13,15 There was no statistically significant increased risk for death or other serious adverse events noted with either vaccine compared with placebo.…”

“…The safety and efficacy of RV5 and RV1 for prevention of rotavirus gastroenteritis in healthy infants have been evaluated in 11 randomized, controlled trials involving more than 146 000 infants worldwide (Table 2), including 3 randomized, controlled trials for RV5 [6][7][8] and 7 randomized, controlled trials for RV1. [9][10][11][12][13][14][15] …”