Comparing the meningococcal serogroup C immune response elicited by a tetanus toxoid conjugate quadrivalent meningococcal vaccine (MenACYW-TT) versus a quadrivalent or monovalent C tetanus toxoid conjugate meningococcal vaccine in healthy meningococcal vaccine-naïve toddlers: A randomised, controlled trial

Knuf, Markus; Rämet, Mika; Stærke, Nina Breinholt; Bertrand-Gerentes, Isabelle; Thollot, Yaël; B’Chir, Siham; Arroum, Habiba; Oster, Philipp

doi:10.1080/21645515.2022.2052657

Cited by 6 publications

(8 citation statements)

References 24 publications

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“…Limitedly to serogroup C, six studies [ 26 , 27 , 28 , 29 , 32 , 33 ] compared the efficacy of MenACWY-TT against MenC. The RR was 1.00 (95% CI 1.00–1.01) with very low heterogeneity ( Figure 4 ).…”

Section: Resultsmentioning

confidence: 99%

“…Five studies compared the safety of MenACWY-TT against MenC [ 26 , 28 , 29 , 32 , 33 ]. Similar to Review 2, none of the included studies compared the safety of MenACWY-D or MenACWY-CRM versus MenC.…”

Section: Resultsmentioning

confidence: 99%

“…Also, subgroup analysis did not show substantial differences (Local mild reactions, RR: 1.12, 95% CI: 0.93–1.35; Local severe reactions, RR: 1.10, 95% CI: 0.30–4.06; Systemic mild reactions, RR: 0.97, 95% CI: 0.81–1.15; Systemic severe reactions, RR: 0.87, 95% CI: 0.23–3.25) Heterogeneity ranged between 0% and 53% in the different analyses. One of the studies was not included in the meta-analysis as it was based on a different AE classification [ 29 ].…”

Section: Resultsmentioning

confidence: 99%

“…

Figure A3 Efficacy of MenACWY-TT vs. MenC (Serogroup C). Subgroup analysis for 12–23 months age group [ 27 , 29 , 32 , 33 ].

Figure A4 Safety of MenACWY-TT vs. MenC (Serogroup C).…”

Section: Figure A1mentioning

confidence: 99%

“… Risk of bias assessment matrix of included studies [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 ]. …”

Section: Figure A1mentioning

confidence: 99%

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Efficacy and Safety of Quadrivalent Conjugate Meningococcal Vaccines: A Systematic Review and Meta-Analysis

et al. 2023

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Over the last decades, different quadrivalent antimeningococcal vaccine formulations (diphteria toxoid conjugate, MenACWY-D; tetanus toxoid conjugate, MenACWY-TT; CRM197 protein conjugate, MenACWY-CRM) have been developed. However, their availability varies, both in terms of authorized formulations and of inclusion in vaccination schedules. Furthermore, several countries include only the monovalent meningococcal C (MenC) vaccine in their immunization programmes. Finally, there is currently no updated systematic review that directly compares the MenACWY formulations. Thus, we summarized the evidence on efficacy and safety through four parallel, independent systematic literature reviews with meta-analysis which included randomized controlled trials comparing the abovementioned vaccines. A total of 16 studies have been included. In terms of efficacy, MenACWY-TT outperformed MenACWY-D and MenACWY-CRM for A, W-135, and Y serogroups, while no significant difference was found for serogroup C. Furthermore, we did not find significant differences in efficacy between MenC and MenACWY-TT. Regarding the safety, we were able to perform a quantitative analysis only between MenACWY-TT and MenC, finding no significant differences. Similarly, among the different MenACWY formulations no relevant differences were identified. These findings suggest that MenACWY-TT could be preferable to other formulations to improve current vaccination programs and to better develop future immunization policies.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…

Figure A3 Efficacy of MenACWY-TT vs. MenC (Serogroup C). Subgroup analysis for 12–23 months age group [ 27 , 29 , 32 , 33 ].

Figure A4 Safety of MenACWY-TT vs. MenC (Serogroup C).…”

Section: Figure A1mentioning

confidence: 99%

“… Risk of bias assessment matrix of included studies [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 ]. …”

Section: Figure A1mentioning

confidence: 99%

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Efficacy and Safety of Quadrivalent Conjugate Meningococcal Vaccines: A Systematic Review and Meta-Analysis

et al. 2023

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Meningokokkenimpfung

Knuf

2024

Monatsschr Kinderheilkd

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Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older

Neveu,

Mallett Moore,

Zambrano

et al. 2023

Infect Dis Ther

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Introduction A favorable benefit-risk balance is required to support licensure of biologics, in keeping with regulatory agencies’ evolving recommendations, including the United States Food and Drugs Administration. We present a structured semi-quantitative benefit-risk analysis of MenACYW-TT, a quadrivalent meningococcal conjugate vaccine against Neisseria meningitidis serogroups, A, C, W and Y versus licensed comparators in individuals aged ≥ 12 months. Methods We used data from six MenACYW-TT clinical trials, stratified by age group, versus licensed vaccines: toddlers (12–23 months; Nimenrix ® [MCV4-TT]), children (2–9 years; Menveo ® [MCV4-CRM]), adolescents (10–17 years; MCV4-CRM or Menactra ® [MCV4-DT]), adults (18–55 years; MCV4-DT) and older adults (≥ 56 years; Menomune ® –A/C/Y/W-135 [MPSV4]). Eight benefit (seroresponse and seroprotection for A, C, W and Y) and five risk outcomes (any and grade 3 solicited injection site and systemic reactions, and serious adverse events) were measured at Day 30 after initial vaccination. Analyses were conducted by baseline vaccination status (meningococcal vaccine-naïve or vaccine-primed). Results MenACYW-TT showed favorable seroresponse and seroprotection among vaccine-naïve participants aged ≥ 2 years, against all serogroups, compared with MCV4-CRM, MCV4-DT and MPSV4. In vaccine-naïve toddlers, there was a favorable effect for serogroup C, but no difference between MenACYW-TT and MCV4-TT for serogroups A, Y and W. A favorable effect for MenACYW-TT against serogroup C was observed in all vaccine-naïve and combined vaccine-naïve and MenC conjugate vaccine-primed groups. For all risk criteria, there were no differences between MenACYW-TT and MCV4s in toddlers, children, adolescents and adults. Results for solicited injection site and systemic reactions favored MPSV4 in older adults. Conclusions The benefit-risk profile for MenACYW-TT showed favorable seroresponse and seroprotection in individuals aged ≥ 2 years and no difference in risk criteria between MenACYW-TT and MCV4s. MenACYW-TT may provide an alternative to the standard-of-care for meningococcal disease prevention in those aged ≥ 12 months. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-023-00864-4.

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Cited by 6 publications

References 24 publications

Efficacy and Safety of Quadrivalent Conjugate Meningococcal Vaccines: A Systematic Review and Meta-Analysis

Efficacy and Safety of Quadrivalent Conjugate Meningococcal Vaccines: A Systematic Review and Meta-Analysis

Meningokokkenimpfung

Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older

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