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Clinical Trial
. 2021 Feb 5:149:e50.
doi: 10.1017/S0950268821000261.

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) vs. a licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine in meningococcal vaccine-naïve and meningococcal C conjugate vaccine-primed toddlers: a phase III randomised study

D van der Vliet  1 , T Vesikari  2 , B Sandner  3 , F Martinón-Torres  4   5 , G Muzsay  6 , A Forsten  2 , T Adelt  7 , C Diaz Gonzalez  8 , R Simko  9 , S B'Chir  1 , D Neveu  10 , E Jordanov  10 , M S Dhingra  10
Affiliations
Clinical Trial

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) vs. a licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine in meningococcal vaccine-naïve and meningococcal C conjugate vaccine-primed toddlers: a phase III randomised study

D van der Vliet et al. Epidemiol Infect. .

Abstract

Vaccination remains the best strategy to reduce invasive meningococcal disease. This study evaluated an investigational tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT) vs. a licensed tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MCV4-TT) (NCT02955797). Healthy toddlers aged 12-23 months were included if they were either meningococcal vaccine-naïve or MenC conjugate (MCC) vaccine-primed (≥1 dose of MCC prior to 12 months of age). Vaccine-naïve participants were randomised 1:1 to either MenACYW-TT (n = 306) or MCV4-TT (n = 306). MCC-primed participants were randomised 2:1 to MenACYW-TT (n = 203) or MCV4-TT (n = 103). Antibody titres against each of the four meningococcal serogroups were measured by serum bactericidal antibody assay using the human complement. The co-primary objectives of this study were to demonstrate the non-inferiority of MenACYW-TT to MCV4-TT in terms of seroprotection (titres ≥1:8) at Day 30 in both vaccine-naïve and all participants (vaccine-naïve and MCC-primed groups pooled). The immune response for all four serogroups to MenACYW-TT was non-inferior to MCV4-TT in vaccine-naïve participants (seroprotection: range 83.6-99.3% and 81.4-91.6%, respectively) and all participants (seroprotection: range 83.6-99.3% and 81.4-98.0%, respectively). The safety profiles of both vaccines were comparable. MenACYW-TT was well-tolerated and demonstrated non-inferior immunogenicity when administered to MCC vaccine-primed and vaccine-naïve toddlers.

Keywords: IMD; MenACYW-TT; quadrivalent meningococcal vaccine; toddlers.

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Conflict of interest statement

FM-T has received honoraria from GSK, Pfizer, Sanofi Pasteur, MSD, Seqirus and Janssen for taking part in advisory boards and expert meetings, and for acting as speaker in congresses outside the scope of the submitted work. FM-T has also acted as principal investigator in RCTs of the above-mentioned companies as well as Ablynx, Regeneron, Roche, Abbott, Novavax and MedImmune, with honoraria paid to his institution. FM-T research activities received support from the Instituto de Salud Carlos III (Proyecto de Investigación en Salud, Acción Estratégica en Salud): Fondo de Investigación Sanitaria (FIS; PI070069/PI1000540/PI1601569/PI1901090) del plan nacional de I + D + I and ‘fondos FEDER’ and 2016-PG071 Consolidación e Estructuración REDES 2016GI-1344 G3VIP (Grupo Gallego de Genética Vacunas Infecciones y Pediatría, ED341D R2016/021). AF, BS, GM, RS, TA and CDG, have no conflicts to declare. TV, received funding to his institute from Sanofi Pasteur for the conduct of this study, has received honoraria from Sanofi Pasteur for advisory boards. DvdV, SB'C, DN, EJ, MSD are employees of Sanofi Pasteur.

Figures

Fig. 1.
Fig. 1.
Participant disposition.
Fig. 2.
Fig. 2.
hSBA GMTs at baseline and Day 30 in the MenACYW-TT and MCV4-TT groups in those who were (a) vaccine-naïve, (b) MCC-primed or (c) vaccine-naïve and MCC-primed combined (PPAS). Error bars indicate 95% CI. GMTR, geometric mean titre ratio (Day 30 MenACYW-TT/MCV4-TT). GMTR*, ratio stratified on priming vaccination background and 95% CI calculated using an analysis of variance model of log10-transformed titres.
Fig. 3.
Fig. 3.
Proportion of participants with hSBA seroresponsea at Day 30 (PPAS). MenACYW-TT or MCV4-TT recipients who were either meningococcal vaccine-naïve or MCC-primed. *Seroresponse defined as follows: for a participant with a pre-vaccination titre <1:8, the post-vaccination titre must be ≥1:16 and for a participant with a pre-vaccination titre ≥1:8, the post-vaccination titre must be a least 4-fold greater than the pre-vaccination titre. Error bars indicate 95% CI.
See this image and copyright information in PMC

References

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