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Pediatrics. 2016 Feb;137(2):e20152603. doi: 10.1542/peds.2015-2603. Epub 2016 Jan 28.

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules.

Author information

1
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;
2
Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio;
3
Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina;
4
Emory University School of Medicine, Atlanta, Georgia;
5
University of Iowa, Iowa City, Iowa;
6
Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland;
7
The University of Texas Medical Branch, Galveston, Texas;
8
Children's Mercy Hospital, Kansas City, Missouri;
9
UCSF Benioff Children's Hospital Oakland, California;
10
Group Health Cooperative, Seattle, Washington; and.
11
Emmes Corporation, Rockville, Maryland.
12
Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine, Nashville, Tennessee; kathryn.edwards@vanderbilt.edu.

Abstract

BACKGROUND AND OBJECTIVES:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01266850.

PMID:
26823540
PMCID:
PMC4732359
DOI:
10.1542/peds.2015-2603
[Indexed for MEDLINE]
Free PMC Article

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