A Dose-Escalation Safety and Immunogenicity Study of Live Attenuated Oral Rotavirus Vaccine 116E in Infants: A Randomized, Double-Blind, Placebo-Controlled Trial

This study, published in the Journal of Infectious Diseases, tested the neonatal rotavirus candidate vaccine 116E in a double-blind, placebo-controlled dose-escalation trial in India. Two doses of the Vero cell-adapted vaccine were evaluated in Indian children. No significant differences in clinical adverse events or laboratory toxicity were observed between vaccine and placebo recipients, and there were no vaccine‐related serious adverse events. The study's favorable results warrant further development of the vaccine candidate and provide optimism that vaccinating infants in the developing world will prevent serious sequelae of rotavirus infection.

Author(s): Bhandari N, Sharma P, Taneja S, et al.

Published: 2009

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    Citation: Bhandari N, Sharma P, Taneja S, et al. A Dose-Escalation Safety and Immunogenicity Study of Live Attenuated Oral Rotavirus Vaccine 116E in Infants: A Randomized, Double-Blind, Placebo-Controlled Trial. Journal of Infectious Diseases. 2009;200(3):421-429.