TY - JOUR
T1 - Safety and immunogenicity of co-administration of meningococcal type A and measles–rubella vaccines with typhoid conjugate vaccine in children aged 15–23 months in Burkina Faso
AU - Sirima, Sodiomon B.
AU - Ouedraogo, Alphonse
AU - Barry, Nouhoun
AU - Siribie, Mohamadou
AU - Tiono, Alfred B.
AU - Nébié, Issa
AU - Konaté, Amadou T.
AU - Berges, Gloria Damoaliga
AU - Diarra, Amidou
AU - Ouedraogo, Moussa
AU - Soulama, Issiaka
AU - Hema, Alimatou
AU - Datta, Shrimati
AU - Liang, Yuanyuan
AU - Rotrosen, Elizabeth T.
AU - Tracy, J. Kathleen
AU - Jamka, Leslie P.
AU - Neuzil, Kathleen M.
AU - Laurens, Matthew B.
N1 - Funding Information:
This trial was funded in part by a grant from the Bill & Melinda Gates Foundation .
Publisher Copyright:
© 2020
PY - 2021/1
Y1 - 2021/1
N2 - Objectives: The World Health Organization pre-qualified single-dose typhoid conjugate vaccine (TCV) and requested data on co-administration with routine vaccines. The co-administration of Typbar TCV (Bharat Biotech International) with routine group A meningococcal conjugate vaccine (MCV-A) and measles–rubella (MR) vaccine was tested. Methods: This was a double-blind, randomized controlled trial performed in Ouagadougou, Burkina Faso. Children were recruited at the 15-month vaccination visit and were assigned randomly (1:1:1) to three groups. Group 1 children received TCV plus control vaccine (inactivated polio vaccine) and MCV-A 28 days later; group 2 children received TCV and MCV-A; group 3 children received MCV-A and control vaccine. Routine MR vaccine was administered to all participants. Safety was assessed at 0, 3, and 7 days after immunization, and unsolicited adverse events and serious adverse events were assessed for 28 days and 6 months after immunization, respectively. Results: A total of 150 children were recruited and vaccinated. Solicited symptoms were infrequent and similar for TCV and control recipients, as were adverse events (group 1, 61.2%; group 2, 64.0%; group 3, 68.6%) and serious adverse events (group 1, 2.0%; group 2, 8.0%; group 3, 5.9%). TCV generated robust immunity without interference with MCV-A vaccine. Conclusions: TCV can be safely co-administered at 15 months with MCV-A without interference. This novel study on the co-administration of TCV with MCV-A provides data to support large-scale uptake in sub-Saharan Africa.
AB - Objectives: The World Health Organization pre-qualified single-dose typhoid conjugate vaccine (TCV) and requested data on co-administration with routine vaccines. The co-administration of Typbar TCV (Bharat Biotech International) with routine group A meningococcal conjugate vaccine (MCV-A) and measles–rubella (MR) vaccine was tested. Methods: This was a double-blind, randomized controlled trial performed in Ouagadougou, Burkina Faso. Children were recruited at the 15-month vaccination visit and were assigned randomly (1:1:1) to three groups. Group 1 children received TCV plus control vaccine (inactivated polio vaccine) and MCV-A 28 days later; group 2 children received TCV and MCV-A; group 3 children received MCV-A and control vaccine. Routine MR vaccine was administered to all participants. Safety was assessed at 0, 3, and 7 days after immunization, and unsolicited adverse events and serious adverse events were assessed for 28 days and 6 months after immunization, respectively. Results: A total of 150 children were recruited and vaccinated. Solicited symptoms were infrequent and similar for TCV and control recipients, as were adverse events (group 1, 61.2%; group 2, 64.0%; group 3, 68.6%) and serious adverse events (group 1, 2.0%; group 2, 8.0%; group 3, 5.9%). TCV generated robust immunity without interference with MCV-A vaccine. Conclusions: TCV can be safely co-administered at 15 months with MCV-A without interference. This novel study on the co-administration of TCV with MCV-A provides data to support large-scale uptake in sub-Saharan Africa.
KW - Burkina Faso
KW - Co-administration
KW - Measles–rubella vaccine
KW - Meningococcal vaccines
KW - Sub-Saharan Africa
KW - Typhoid conjugate vaccine
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U2 - 10.1016/j.ijid.2020.10.103
DO - 10.1016/j.ijid.2020.10.103
M3 - Article
C2 - 33176205
AN - SCOPUS:85097370201
VL - 102
SP - 517
EP - 523
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
SN - 1201-9712
ER -