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Войти в исследования Pediatric research · 2026
Meningococcal quadrivalent ACYW-TT conjugated vaccine at 6-23 months: phase III study (US/Puerto Rico).
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Duffy Cheryl, Lyabis Olga, Dhingra Mandeep Singh, Zambrano Betzana, Chaix Julie, Syrkina Olga, B'Chir Siham, Gupta Sandeep, Rehm Christine
Аннотация
BACKGROUND: A quadrivalent meningococcal tetanus toxoid-conjugate vaccine, MenACYW-TT, was developed to provide broad protection against invasive meningococcal disease across all age groups. We evaluated the immunogenicity and safety of MenACYW-TT as a two-dose series (1 + 1 schedule) co-administered with routine pediatric vaccines to infants from 6 months of age.
METHODS: This phase III modified double-blind, randomized study (NCT03691610) enrolled healthy infants (n = 750) and toddlers (n = 200). Infants were randomized 1:1 to receive MenACYW-TT (Group 1) or another quadrivalent conjugate vaccine, MenACWY-CRM (Group 2) at ages 6-7 and 12-13 months, co-administered with routine vaccines. Toddlers were randomized 1:1 to receive MenACYW-TT (Group 3) or another quadrivalent conjugate vaccine, MenACWY-DT (Group 4) at ages 17-19 and 20-23 months. Functional antibodies against the four meningococcal serogroups were assessed by serum bactericidal antibody assay using human complement (hSBA). Safety was assessed up to 6 months post-vaccination.
RESULTS: Seroresponse to MenACYW-TT was non-inferior to that with MenACWY-CRM against all four serogroups (seroresponse rates 30 days post-dose 2 were 89.4-99.3% and 82.9-97.7%, respectively). All vaccines were well tolerated.
CONCLUSIONS: These findings support MenACYW-TT administration as a two-dose series in children from 6 months of age.
STUDY REGISTRATION: Clinicaltrials.gov: NCT03691610.
IMPACT: When administered as a two-dose series (1 + 1 schedule), MenACYW-TT demonstrated comparable/higher immunogenicity to MenACWY-CRM (ages 6-7 and 12-13 months) and the safety profiles of these quadrivalent meningococcal vaccines were similar. MenACYW-TT was non-inferior to MenACWY-CRM in terms of seroresponse rates and proportion of participants with antibody titer ≥1:8 after a second dose at age 12-13 months. This phase III study is the first to confirm the safety and immunogenicity of MenACYW-TT in infants and supports its use as a two-dose series from 6 months of age.
METHODS: This phase III modified double-blind, randomized study (NCT03691610) enrolled healthy infants (n = 750) and toddlers (n = 200). Infants were randomized 1:1 to receive MenACYW-TT (Group 1) or another quadrivalent conjugate vaccine, MenACWY-CRM (Group 2) at ages 6-7 and 12-13 months, co-administered with routine vaccines. Toddlers were randomized 1:1 to receive MenACYW-TT (Group 3) or another quadrivalent conjugate vaccine, MenACWY-DT (Group 4) at ages 17-19 and 20-23 months. Functional antibodies against the four meningococcal serogroups were assessed by serum bactericidal antibody assay using human complement (hSBA). Safety was assessed up to 6 months post-vaccination.
RESULTS: Seroresponse to MenACYW-TT was non-inferior to that with MenACWY-CRM against all four serogroups (seroresponse rates 30 days post-dose 2 were 89.4-99.3% and 82.9-97.7%, respectively). All vaccines were well tolerated.
CONCLUSIONS: These findings support MenACYW-TT administration as a two-dose series in children from 6 months of age.
STUDY REGISTRATION: Clinicaltrials.gov: NCT03691610.
IMPACT: When administered as a two-dose series (1 + 1 schedule), MenACYW-TT demonstrated comparable/higher immunogenicity to MenACWY-CRM (ages 6-7 and 12-13 months) and the safety profiles of these quadrivalent meningococcal vaccines were similar. MenACYW-TT was non-inferior to MenACWY-CRM in terms of seroresponse rates and proportion of participants with antibody titer ≥1:8 after a second dose at age 12-13 months. This phase III study is the first to confirm the safety and immunogenicity of MenACYW-TT in infants and supports its use as a two-dose series from 6 months of age.