Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee

December 14, 2005

Briefing Information

RotaTeq™ (rotavirus vaccine, live, oral, pentavalent)

FDA Briefing Document, Rosemary Tiernan, MD, MPH (HTM) (PDF)

Errata to the FDA Briefing Document (HTM) (PDF)

FDA Statistical Review and Evaluation, Jingyee Kou, PhD (HTM) (PDF)


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

RotaTeq™ (rotavirus vaccine, live, oral, pentavalent), Merck Research Laboratories (PDF)