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.
journal_name
Pediatricsjournal_title
Pediatricsauthors
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.doi
10.1542/peds.2015-2603subject
Has Abstractpub_date
2016-02-01 00:00:00pages
e20152603issue
2eissn
0031-4005issn
1098-4275pii
peds.2015-2603journal_volume
137pub_type
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