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Milestone in Phase II Clinical Trial for Rotavirus Vaccine reached

International Medica Foundation Reaches Final Vaccination Milestone in Phase II Clinical Trial for Rotavirus Vaccine

Lower-cost vaccine to prevent diarrhea is being tested in Africa


ROCHESTER, MINN. (Jan. 14, 2010) – Rotavirus is responsible for the deaths of more than 1,500 infants and children daily, mainly in developing countries. To combat this killer of children, the International Medica Foundation is sponsoring a Phase II clinical trial of its oral rotavirus vaccine, RotaShield®.

The trial is being conducted in northern Ghana, Africa, and has reached the milestone of the nearly 1,000 infants in the study having received the second of two doses of either RotaShield or a placebo. This is the final rotavirus vaccination for these infants and their health will be closely monitored over the next year to determine the efficacy of the vaccine in preventing life-threatening diarrhea.

 




A nurse in Ghana, Africa, prepares a final dose of International Medica Foundation’s oral rotavirus vaccine, RotaShield®



RotaShield originally was developed to be administered in three oral doses at two, four and six months of age but there is the potential that two doses of the vaccine may also be very effective in preventing severe diarrhea. This clinical trial uses only two oral doses of the vaccine with the first dose being administered soon after birth and the second dose before the infant is 60 days old.

Providing a rotavirus vaccine to very young infants may also protect them against rotavirus at an earlier age – when they are highly vulnerable to the severe effects of diarrhea.

 



A nurse in Ghana, Africa, administers the International Medica Foundation’s final dose of the oral rotavirus vaccine, RotaShield®, to an infant in a Phase II clinical trial.



The International Medica Foundation believes that the use of RotaShield, once additional clinical trials are completed, may be the nearest term and the most cost-effective way to prevent many of the deaths of children occurring daily in the developing world due to rotavirus.

About International Medica Foundation

The International Medica Foundation, which has the rights to RotaShield, is a nonprofit foundation that focuses on ensuring that a safe, effective and affordable rotavirus vaccine is clinically tested and then can be provided to families in need globally. The International Medica Foundation also aims to ensure that the manufacturing process for RotaShield is available to countries with the appropriate vaccine manufacturing capabilities.

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