

@article {3741,
	title = {Safety and immunogenicity of RIX4414 live attenuated human rotavirus vaccine in adults, toddlers and previously uninfected infants.},
	journal = {Vaccine},
	volume = {22},
	number = {21-22},
	year = {2004},
	pages = {2836{\textendash}2842},
	abstract = {<p>A live attenuated human rotavirus \{\{\}(HRV)\{\}\} vaccine, strain \{\{\}RIX4414,\{\}\} was tested sequentially in adults, previously infected toddlers, and previously uninfected infants. A single dose was given to adults and toddlers and found well tolerated. Next, a dose ranging (three different viral concentrations) safety and immunogenicity study was conducted in rotavirus \{\{\.I}gA\{\}\} antibody negative infants \{\{\}(N=\{\}\} 192), who received two doses of \{\{\}RIX4414\{\}\} vaccine or placebo at 2 and 4 months of age. No side effects were seen after vaccination. Specifically, administration of \{\{\}RIX4414\{\}\} vaccine was not temporally associated with fever, diarrhea, or increase in liver transaminases. Rotavirus \{\{\.I}gA\{\}\} seroconversion ranged from 50 to 88\{\%\} after one dose and from 73 to 96\{\%\} after two doses, depending on vaccine titer. After the first dose, on days 7-9 post vaccination, between 38 and 60\{\%\} of the infants shed the vaccine virus, whereas after the second dose only 0 to 13\{\%\} of the vaccinees shed the vaccine virus. It is concluded that \{\{\}RIX4414\{\}\} strain \{\{\}HRV\{\}\} vaccine is virtually non-reactogenic and, at high titer, highly immunogenic in susceptible infants.</p>
},
	doi = {10.1016/j.vaccine.2004.01.044},
	url = {http://dx.doi.org/10.1016/j.vaccine.2004.01.044},
	author = {Vesikari, T and Karvonen, A and Korhonen, T and Espo, M and Lebacq, E and Forster, J and Zepp, F and Delem, A and De Vos, B}
}
