Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study

Dhingra, Mandeep Singh; Namazova-Baranova, L.; Arredondo-Garcı́a, José Luis; Kim, K. H.; Limkittikul, Kriengsak; Jantarabenjakul, Watsamon; Перминова, О. А.; Kobashi, Ilya Angélica Rochín; Bae, Chong‐Woo; Ojeda, Joyce; Park, J.; Chansinghakul, Danaya; B’Chir, Siham; Neveu, David; Bonaparte, Matthew; Jordanov, Emilia

doi:10.1017/s0950268821000698

Cited by 11 publications

(13 citation statements)

References 36 publications

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“…The coadministration of MenACWY-TT with the recommended vaccines in infants will ultimately increase compliance and decrease visits to health care providers; thus, safety and immunogenicity when coadministered with MenACWY-TT are important. 23 GMTs were reported at day 0 and day 30, and both the MenACWY-TT with MMR and varicella and MenACWY-TT groups showed an increase in hSBA GMT from baseline to day 30 that was comparable. The most commonly reported solicited injection site reaction was injection site tenderness postvaccination with MMR, varicella, or MenACWY-TT.…”

Section: Phase III Studiesmentioning

confidence: 86%

“…10,[16][17][18][19] Other studies conducted, which will be discussed for completeness, include MET44, MET51, MET54, MET57, and MET62. [20][21][22][23][24] Studies are listed in numerical order in Table 1.…”

Section: Clinical Studiesmentioning

confidence: 99%

“…Despite these limitations, MenACWY-TT's immunogenicity and safety was shown to be noninferior when compared to MPSV4, MenACWY-CRM, MenACWY-D, and MCV4-TT. 10,[16][17][18][19][20][21][22][23][24] Noninferiority was met for the primary objective if the lower limit of the 2-sided CI of the difference between the compared seroresponse rates was greater than −10%. For the studies evaluated for FDA approval, the lower limits of the CI were as follows: (A) 1.1% to 14.8%, (C) 21% to 42.2%, (W) 8.9% to 22.5%, (Y) 7.7% to 24.6%.…”

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

“…MET57, a phase III, open-label, randomized study assessed the immunogenicity and safety of MenACWY-TT alone and in combination with other vaccines in healthy infants aged 12 to 23 months. 23 A total of 1183 infants in South Korea, Thailand, the Russian Federation, and Mexico were randomized into 12 groups comparing (1) MenACWY-TT vaccination alone; (2) MenACWY-TT coadministered with measles, mumps, and rubella (MMR) and varicella; (3) MenACWY-TT with a combination of tetanus and pertussis (DTaP), polio (IPV), hepatitis B (HepB), and Haemophilus influenzae type b (Hib; DTaP-IPV-HepB-Hib); and (4) MenACWY-TT coadministered with pneumococcal conjugate vaccine (PCV13). As vaccine schedules for infants vary between countries, the 12 groups were divided based on the schedules, country-specific recommendations, and coverage rates as follows: in South Korea and Thailand, MenACWY-TT was coadministered with MMR and varicella; in Mexico, MenACWY-TT was coadministered with a combination of DTaP, IPV, HepB, and Hib; and in Russia, MenACWY-TT was coadministered with PCV13.…”

Section: Clinical Studiesmentioning

confidence: 99%

“…Overall, no significant effects were observed related to immunogenicity and safety when MenACWY-TT was coadministered with other vaccines; however, the groups of participants were not large enough to make statistical comparisons because this was designed as only a descriptive study. 23 Further studies may be necessary for other countries with differing vaccine schedules and other potential coadministered vaccines.…”

Section: Clinical Studiesmentioning

confidence: 99%

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MenQuadfi (MenACWY-TT): A New Vaccine for Meningococcal Serogroups ACWY

2021

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Objective This article reviews data encompassing the pharmacology, efficacy, and safety of MenACWY-TT (MenQuadfi), a conjugate vaccine to prevent meningococcal disease from serogroups A, C, W, Y. Data Sources A literature review was conducted in PubMed, MEDLINE, and ClinicalTrials.gov from inception up to July 2021, using the search terms MenQuadfi, meningococcal ACWY vaccine, MCV4, and menacwy. Articles from reference lists were included to identify potential relevant literature. Study Selection and Data Extraction Data were limited to randomized phase II and III clinical studies published in the English language, evaluating the efficacy and safety of MenACWY-TT. Animal studies and studies not utilizing MenACWY-TT were excluded. Data Synthesis One phase II and 4 phase III randomized clinical studies, enrolling approximately 7700 participants, aged 2 years to 97 years old found that MenACWY-TT was noninferior when compared to established MenACWY vaccines, as measured by surrogate immunogenicity end points. In studies evaluating primary dose vaccination, conducted in those aged 2 to 97 years of age, the difference in seroresponse rates, reported by the lower bound of the 95% CI, was (A) 1.1% to 14.8%, (C) 21% to 42.2%, (Y) 7.7% to 24.6%, and (W) 8.9% to 22.5%. Relevance to Patient Care and Clinical Practice Despite the low incidence of meningococcal disease in the United States, meningococcal disease causes significant morbidity and mortality if not prevented. Conclusion MenACWY-TT is noninferior to currently approved quadrivalent meningococcal vaccines and shows similar immunogenicity and safety as both an initial vaccine for prevention as well as a booster dose.

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Section: Phase III Studiesmentioning

confidence: 86%

Section: Clinical Studiesmentioning

confidence: 99%

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

Section: Clinical Studiesmentioning

confidence: 99%

Section: Clinical Studiesmentioning

confidence: 99%

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MenQuadfi (MenACWY-TT): A New Vaccine for Meningococcal Serogroups ACWY

2021

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Observational analysis of the immunogenicity and safety of various types of spinal muscular atrophy vaccines

Sun,

Wang,

Zhong

2024

Inflammopharmacol

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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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Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study

Abstract: Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study. Epidemiology and Infection 149, e90, 1-10.

Cited by 11 publications

References 36 publications

MenQuadfi (MenACWY-TT): A New Vaccine for Meningococcal Serogroups ACWY

MenQuadfi (MenACWY-TT): A New Vaccine for Meningococcal Serogroups ACWY

Observational analysis of the immunogenicity and safety of various types of spinal muscular atrophy vaccines

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

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