Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine

• Published in: The New England journal of medicine Vol. 354; no. 1; pp. 23 - 33
• Main Authors: Vesikari, Timo, Matson, David O, Dennehy, Penelope, Van Damme, Pierre, Santosham, Mathuram, Rodriguez, Zoe, Dallas, Michael J, Heyse, Joseph F, Goveia, Michelle G, Black, Steven B, Shinefield, Henry R, Christie, Celia D.C, Ylitalo, Samuli, Itzler, Robbin F, Coia, Michele L, Onorato, Matthew T, Adeyi, Ben A, Marshall, Gary S, Gothefors, Leif, Campens, Dirk, Karvonen, Aino, Watt, James P, O'Brien, Katherine L, DiNubile, Mark J, Clark, H Fred, Boslego, John W, Offit, Paul A, Heaton, Penny M
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 05.01.2006
• Subjects: Administration, Oral; Animals; Antibodies, Viral - blood; Babies; Biological and medical sciences; Cattle; Diarrhea, Infantile - prevention & control; Diarrhea, Infantile - virology; Double-Blind Method; Female; Fever - etiology; Gastroenteritis - prevention & control; Gastroenteritis - virology; Gastroenteritis/prevention & control/virology; Gastrointestinal Hemorrhage - etiology; General aspects; Health Resources - utilization; Health risk assessment; Hospitalization; Humans; Immunoglobulin A - blood; Infant; Intussusception - etiology; Male; Medical disorders; Medical sciences; Medical treatment; Reassortant Viruses; Risk; Rotavirus - classification; Rotavirus - immunology; Rotavirus Infections - prevention & control; Rotavirus Vaccines - administration & dosage; Rotavirus Vaccines - adverse effects; Rotavirus Vaccines - immunology; Rotavirus Vaccines/administration & dosage/adverse effects/immunology; Rotavirus/classification/immunology; Vaccines; Vaccines, Attenuated - administration & dosage; Vaccines, Attenuated - adverse effects; Vaccines, Attenuated - immunology; Virus; Medicine; Prevention; Immunoprophylaxis; Bovine rotavirus; Rotavirus; Human rotavirus; Toxicity; Vaccine; Safety; Reoviridae; Administration; Attenuated/administration & dosage/adverse effects/immunology; Antibodies; Diarrhea; Infantile/prevention & control/virology; Oral; Vaccines; Viral/blood

In this randomized trial, the clinical efficacy of an oral, live pentavalent human–bovine reassortant vaccine was estimated to be 98.0 percent against severe gastroenteritis due to rotavirus. In the safety study, which included 68,038 infants, the rates of intussusception were similar in the vaccine...