Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Summary

Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in children. Vaccines can prevent many types of infections and work by causing the body to make proteins called antibodies that fight infection. For some vaccines, more than one vaccination is needed so that the body will make enough antibodies to fight infection. The vaccines (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for infants by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). These vaccines require either 2 or 3 vaccinations to be effective. Healthy infants between 6 weeks and 14 weeks, 6 days of age at Visit 1 will participate for about 10-12 months. Study procedures include reaction assessment and blood sample.

Timeline

Start

2011-03

Primary completion

2013-10

Completion

2014-03

Outcome

Met primary endpoint

paper Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. PMID 26823540 ↗

Publications

• Libster R, McNeal M, Walter EB, Shane AL, Winokur P, Cress G, Berry AA, Kotloff KL, Sarpong K, Turley CB, Harrison CJ, Pahud BA, Marbin J, Dunn J, El-Khorazaty J, Barrett J, Edwards KM; VTEU Rotavirus Vaccine Study Work Group. Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules. Pediatrics. 2016 Feb;137(2):e20152603. doi: 10.1542/peds.2015-2603. Epub 2016 Jan 28.

Drugs

Indications