A short report on the highlights of world-wide development of RIX4414: a North American experience comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine (RIX4414) in infants in the United Sta

Abstract:

:This randomized, double-blind trial conducted in the US and Canada was conducted to compare the safety and immunogenicity of two dosages of live attenuated oral monovalent G1 human rotavirus (HRV) vaccine administered orally at a 2-month interval concomitantly with routine childhood vaccines to healthy infants 5-15 weeks of age. No SAEs considered related to vaccine were reported. The incidence of solicited symptoms was similar among treatment groups during the 15-day post-vaccination surveillance periods. No significant difference in vaccine take after 2 doses (88.0% in high dose group and 81.5% in low dose group) was seen between vaccine groups. Two doses of either dosage level of HRV vaccine administered concurrently with routine childhood vaccines to healthy infants were well tolerated and elicited excellent vaccine takes.

journal_name

Vaccine

journal_title

Vaccine

authors

Dennehy PH,North American Human Rotavirus Vaccine Study Group.

doi

10.1016/j.vaccine.2005.07.030

subject

Has Abstract

pub_date

2006-05-01 00:00:00

pages

3780-1

issue

18

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(05)00672-9

journal_volume

24

pub_type

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