Published online February 29, 2008
PEDIATRICS Vol. 121 No. 3 March 2008, pp. 508-516 (doi:10.1542/peds.2007-1064)
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ARTICLE

Safety and Immunogenicity of Concurrent Administration of Live Attenuated Influenza Vaccine With Measles-Mumps-Rubella and Varicella Vaccines to Infants 12 to 15 Months of Age

Terry Nolan, MBBS, PhDa, David I. Bernstein, MDb, Stan L. Block, MDc, Milo Hilty, MDd, Harry L. Keyserling, MDe, Colin Marchant, MDf, Helen Marshall, MBBSg, Peter Richmond, MDh, Ram Yogev, MDi, Julie Cordova, BScj, Iksung Cho, MSj, Paul M. Mendelman, MDj for the LAIV Study Group

a School of Population Health, University of Melbourne and Murdoch Children's Research Institute, Victoria, Australia
b Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
c Kentucky Pediatric Research, Bardstown, Kentucky
d Pediatric Clinical Trials International, Columbus, Ohio
e Division of Infectious Diseases, Epidemiology, and Immunology, Emory University, Atlanta, Georgia
f School of Medicine, Boston University Medical Center, Boston, Massachusetts
g Discipline of Paediatrics, University of Adelaide and Children, Youth, and Women's Health Service, Adelaide, Australia
h Princess Margaret Hospital for Children, Subiaco, Australia
i Infectious Diseases, Children's Memorial Hospital, Chicago, Illinois
j Departments of Clinical Development and Biostatistics, MedImmune, Gaithersburg, Maryland

OBJECTIVE. This study evaluated the safety, tolerability, and immunogenicity of live attenuated influenza vaccine administered concurrently with measles-mumps-rubella vaccine and varicella vaccine to healthy children 12 to 15 months of age.

METHODS. Children were assigned randomly to receive (1) measles-mumps-rubella vaccine, varicella vaccine, and intranasal placebo on day 0, followed by 1 dose of live attenuated influenza vaccine on days 42 and 72; (2) measles-mumps-rubella, varicella, and live attenuated influenza vaccines on day 0, followed by a second dose of live attenuated influenza vaccine on day 42 and intranasally administered placebo on day 72; or (3) 1 dose of live attenuated influenza vaccine on days 0 and 42, followed by measles-mumps-rubella and varicella vaccines on day 72. Serum samples were collected before vaccination on days 0, 42, and 72. Reactogenicity events and adverse events were collected through day 41 after concurrent vaccinations and through day 10 after administration of live attenuated influenza vaccine or placebo alone.

RESULTS. Among 1245 (99.5%) evaluable children, seroresponse rates and geometric mean titers for measles-mumps-rubella vaccine and varicella vaccine were similar with concurrent administration of live attenuated influenza vaccine or placebo (seroresponse rates of ≥96% for measles-mumps-rubella vaccine and ≥82% for varicella vaccine in both groups). Hemagglutinin-inhibiting antibody geometric mean titers and seroconversion rates to influenza strains in live attenuated influenza virus vaccine were similar after the vaccine was administered alone (seroconversion rates of 98%, 92%, and 44% for H3, B, and H1 strains, respectively) or with measles-mumps-rubella and varicella vaccines (seroconversion rates of 98%, 96%, and 43%). The incidences of reactogenicity events and adverse events were similar among treatment groups.

CONCLUSIONS. Concurrent administration of live attenuated influenza vaccine with measles-mumps-rubella vaccine and varicella vaccine provided equivalent immunogenicity, compared with separate administration, and was well tolerated.

Key Words: live attenuated influenza virus vaccine • varicella vaccine • measles-mumps-rubella vaccine • immunogenicity • concurrent vaccinations • children

Abbreviations: AE—adverse event • CI—confidence interval • GMT—geometric mean titer • HAI—hemagglutination-inhibiting • LAIV—live attenuated influenza vaccine • MMR—measles-mumps-rubella • RE—reactogenicity event

Accepted Aug 15, 2007.


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