An Open-Label, Randomized Study of a 9-Valent Human Papillomavirus Vaccine Given Concomitantly with Diphtheria, Tetanus, Pertussis, and Poliomyelitis Vaccines to Healthy Adolescents 11 to 15 Years of Age

Pope Kosalaraksa, Jesper Mehlsen, Timo Vesikari, Aino Forstén, Klaus Helm, Pierre Van Damme, Elmar A Joura, Karen Ciprero, Roger Maansson, Alain Luxembourg, Ajoke Sobanjo-Ter Meulen

    35 Citationer (Scopus)

    Abstract

    BACKGROUND: A nine-valent human papillomavirus (9vHPV) vaccine has recently been reported to be safe and highly efficacious against infection and disease related to HPV6/11/16/18/31/33/45/52/58. We evaluated the immunogenicity and safety of the 9vHPV vaccine administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis, and inactivated poliomyelitis vaccine).

    METHODS: This open-label, randomized, multicenter study enrolled 1054 males and females ages 11-15 years. Subjects were randomly assigned to each group in a 1:1 ratio. Subjects received a 0.5mL dose of 9vHPV vaccine intramuscularly at day 1, months 2 and 6, and a 0.5 mL dose of REPEVAX either on day 1 (concomitant vaccination group; n = 526) or at month 1 (non-concomitant vaccination group, n = 528). Serologic responses for each vaccine component were tested by one-sided tests of non-inferiority between groups. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored.

    RESULTS: Non-inferiority of anti-HPV GMTs and seroconversion rates for all 9vHPV antigens were demonstrated for the concomitant group compared with the non-concomitant group. Seroconversion rates for the 9vHPV vaccine types were ≥99.8% in both groups at month 7. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, and all polio and pertussis antigens for both groups. There were no vaccine-related serious AEs.

    CONCLUSION: Overall, concomitant administration of 9vHPV vaccine and REPEVAX was generally well tolerated and did not interfere with the immune response to either vaccine. This strategy would minimize the number of visits required to deliver each vaccine individually.NCT01073293.

    OriginalsprogEngelsk
    TidsskriftThe Pediatric infectious disease journal
    Vol/bind34
    Udgave nummer6
    Sider (fra-til)627–634
    ISSN0891-3668
    DOI
    StatusUdgivet - jun. 2015

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