title: Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules.
abstract: OBJECTIVE
  Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone.
  
  
  METHODS
  Randomized, multicenter, open-label study. Healthy infants (6-14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A ≥20 U/mL) were compared in all the vaccine groups.
  
  
  RESULTS
  Between March 2011 and September 2013, 1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated.
  
  
  CONCLUSIONS
  Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone.
authors.affiliation: Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine, Nashville, Tennessee; Fundación INFANT, CABA, Argentina; National Scientific and Technical Research Council (CONICET), CABA, Argentina;
authors.forename: Romina
authors.initials: R
authors.lastname: Libster
authors.affiliation: Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio;
authors.forename: Monica
authors.initials: M
authors.lastname: McNeal
authors.affiliation: Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina;
authors.forename: Emmanuel B
authors.initials: EB
authors.lastname: Walter
authors.affiliation: Emory University School of Medicine, Atlanta, Georgia;
authors.forename: Andi L
authors.initials: AL
authors.lastname: Shane
authors.affiliation: University of Iowa, Iowa City, Iowa;
authors.forename: Patricia
authors.initials: P
authors.lastname: Winokur
authors.affiliation: University of Iowa, Iowa City, Iowa;
authors.forename: Gretchen
authors.initials: G
authors.lastname: Cress
authors.affiliation: Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland;
authors.forename: Andrea A
authors.initials: AA
authors.lastname: Berry
authors.affiliation: Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland;
authors.forename: Karen L
authors.initials: KL
authors.lastname: Kotloff
authors.affiliation: The University of Texas Medical Branch, Galveston, Texas;
authors.forename: Kwabena
authors.initials: K
authors.lastname: Sarpong
authors.affiliation: The University of Texas Medical Branch, Galveston, Texas;
authors.forename: Christine B
authors.initials: CB
authors.lastname: Turley
authors.affiliation: Children's Mercy Hospital, Kansas City, Missouri;
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Harrison
authors.affiliation: Children's Mercy Hospital, Kansas City, Missouri;
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Pahud
authors.affiliation: UCSF Benioff Children's Hospital Oakland, California;
authors.forename: Jyothi
authors.initials: J
authors.lastname: Marbin
authors.affiliation: Group Health Cooperative, Seattle, Washington; and.
authors.forename: John
authors.initials: J
authors.lastname: Dunn
authors.affiliation: Emmes Corporation, Rockville, Maryland.
authors.forename: Jill
authors.initials: J
authors.lastname: El-Khorazaty
authors.affiliation: Emmes Corporation, Rockville, Maryland.
authors.forename: Jill
authors.initials: J
authors.lastname: Barrett
authors.affiliation: Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine, Nashville, Tennessee; kathryn.edwards@vanderbilt.edu.
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Edwards
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D061214:Patient Safety; D012401:Rotavirus / Q000276:immunology*; D022243:Rotavirus Vaccines / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D015415:Biomarkers; D022243:Rotavirus Vaccines
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