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Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules.

Publication ,  Journal Article
Libster, R; McNeal, M; Walter, EB; Shane, AL; Winokur, P; Cress, G; Berry, AA; Kotloff, KL; Sarpong, K; Turley, CB; Harrison, CJ; Pahud, BA ...
Published in: Pediatrics
February 2016

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.

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Published In

Pediatrics

DOI

EISSN

1098-4275

Publication Date

February 2016

Volume

137

Issue

2

Start / End Page

e20152603

Location

United States

Related Subject Headings

  • Rotavirus Vaccines
  • Rotavirus
  • Pediatrics
  • Patient Safety
  • Male
  • Infant
  • Immunization Schedule
  • Humans
  • Female
  • Enzyme-Linked Immunosorbent Assay
 

Citation

APA
Chicago
ICMJE
MLA
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Libster, R., McNeal, M., Walter, E. B., Shane, A. L., Winokur, P., Cress, G., … VTEU Rotavirus Vaccine Study Work Group. (2016). Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules. Pediatrics, 137(2), e20152603. https://doi.org/10.1542/peds.2015-2603
Libster, Romina, Monica McNeal, Emmanuel B. Walter, Andi L. Shane, Patricia Winokur, Gretchen Cress, Andrea A. Berry, et al. “Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules.Pediatrics 137, no. 2 (February 2016): e20152603. https://doi.org/10.1542/peds.2015-2603.
Libster R, McNeal M, Walter EB, Shane AL, Winokur P, Cress G, et al. Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules. Pediatrics. 2016 Feb;137(2):e20152603.
Libster, Romina, et al. “Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules.Pediatrics, vol. 137, no. 2, Feb. 2016, p. e20152603. Pubmed, doi:10.1542/peds.2015-2603.
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.

Published In

Pediatrics

DOI

EISSN

1098-4275

Publication Date

February 2016

Volume

137

Issue

2

Start / End Page

e20152603

Location

United States

Related Subject Headings

  • Rotavirus Vaccines
  • Rotavirus
  • Pediatrics
  • Patient Safety
  • Male
  • Infant
  • Immunization Schedule
  • Humans
  • Female
  • Enzyme-Linked Immunosorbent Assay