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    Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomised controlled phase 2 trial

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    Author
    Sirima, Sodiomon B
    Ouedraogo, Alphonse
    Barry, Nouhoun
    Siribie, Mohamadou
    Tiono, Alfred
    Nébié, Issa
    Konaté, Amadou
    Berges, Gloria Damoaliga
    Diarra, Amidou
    Ouedraogo, Moussa
    Bougouma, Edith C
    Soulama, Issiaka
    Hema, Alimatou
    Datta, Shrimati
    Liang, Yuanyuan
    Rotrosen, Elizabeth T
    Kathleen Tracy, J
    Jamka, Leslie P
    Oshinsky, Jennifer J
    Pasetti, Marcela F
    Neuzil, Kathleen M
    Laurens, Matthew B
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    Date
    2021-06-01
    Journal
    International Journal of Infectious Diseases : IJID
    Publisher
    Elsevier Ltd.
    Type
    Article
    
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    See at
    https://doi.org/10.1016/j.ijid.2021.05.061
    Abstract
    Objectives: In 2017, the World Health Organisation (WHO) pre-qualified a single-dose typhoid conjugate vaccine (TCV) and identified TCV co-administration studies as a research priority. We tested co-administration of Typbar TCV® (Bharat Biotech International) with measles-rubella (MR) and yellow fever (YF) vaccines. Methods: We conducted a randomised, double-blind, and controlled, phase 2 trial in Ouagadougou, Burkina Faso. Healthy children aged 9-11 months were randomised 1:1 to receive TCV (Group 1) or control vaccine (inactivated polio vaccine (IPV), Group 2). Vaccines were administered intramuscularly with routine MR and YF vaccines. Safety was assessed by 1) local and systemic reactions on days 0, 3, and 7; 2) unsolicited adverse events within 28 days; and 3) serious adverse events (SAEs) within 6 months after immunisation. Results: We enrolled, randomised, and vaccinated 100 eligible children (49 Group 1 and 51 Group 2). Safety outcomes occurred with similar frequency in both groups: local/solicited reactions (Group 1: 1/49, Group 2: 3/50), systemic/solicited reactions (Group 1: 4/49, Group 2: 9/50), unsolicited adverse events (Group 1: 26/49, Group 2: 33/51), and SAEs (Group 1: 2/49, Group 2: 3/51). TCV conferred robust immunogenicity without interference with MR or YF vaccines. Conclusion: TCV can be safely co-administered with MR and YF vaccines to children at the 9-month vaccination visit.
    Rights/Terms
    Copyright © 2021. Published by Elsevier Ltd.
    Keyword
    Burkina Faso
    Typhoid Fever
    Yellow fever vaccine
    coadministration
    typhoid conjugate vaccine
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/15989
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.ijid.2021.05.061
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