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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Sirima, Sodiomon BOuedraogo, 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
Date
2021-06-01Journal
International Journal of Infectious Diseases : IJIDPublisher
Elsevier Ltd.Type
Article
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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.Identifier to cite or link to this item
http://hdl.handle.net/10713/15989ae974a485f413a2113503eed53cd6c53
10.1016/j.ijid.2021.05.061
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