The investigational meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (ACWY-TT) and the seasonal influenza virus vaccine are immunogenic and well-tolerated when co-administered in adults

Abstract

Co-administration of meningococcal serogroups A, C, W-135 and Y conjugate vaccine (ACWY-TT) with seasonal influenza vaccine was investigated in a subset of adults enrolled in a larger study evaluating lot-to-lot consistency of ACWY-TT and non-inferiority to licensed tetravalent meningococcal polysaccharide vaccine (MenPS). Subjects in this sub-study were randomized (3:1:1) to receive ACWY-TT alone (ACWY-TT group) or with seasonal influenza vaccine (Coad), or licensed MenPS alone. Serum bactericidal antibodies (rSBA) and serum haemagglutination-inhibition (HI) antibody titers were measured pre- and 1 mo post-vaccination. Non-inferiority of the Coad group compared with ACWY-TT group was demonstrated in terms of rSBA geometric mean antibody titers (GMTs) to serogroups A, W-135 and Y. For serogroup C the pre-defined non-inferiority limit was marginally exceeded. Post-vaccination rSBA GMTs were significantly higher (exploratory analysis) in the Coad group compared with the MenPS group for serogroups A, W-135, and Y and were similar to the MenPS group for serogroup C. Overall, > 97% of subjects achieved rSBA titers ≥ 1:128 for all serogroups. The Coad group met all criteria defined by the Committee on Human Medicinal Products (CHMP) for seroprotection, seroconversion and seroconversion factor for HI antibodies for all three influenza strains. Grade 3 solicited local/general symptoms were reported by ≤ 1.9% of subjects in any group. These data support the co-administration of ACWY-TT with seasonal influenza vaccine when protection is needed against both diseases. This study is registered at clinicaltrials.gov NCT00453986

One or Two Doses of Quadrivalent Meningococcal Serogroups A, C, W-135 and Y Tetanus Toxoid Conjugate Vaccine Is Immunogenic in 9- to 12-Month-Old Children

“…Clinical trials conducted in Europe, Asia, the Middle East and the United States have demonstrated that MenACWY-TT is immunogenic and well-tolerated in children from 12 months of age, [12][13][14][15][16] as well as in adolescents and adults. [17][18][19][20][21] Exploratory analyses in a study of US adolescents showed that a single dose of MenACWY-TT induced statistically significantly higher hSBA titers against all 4 serogroups and significantly higher percentages of subjects with hSBA titers ≥1:8 for serogroups A, W-135 and Y than the US-licensed MenACWY-DT vaccine. 18 Another study found that 15 months after vaccinating toddlers and children with MenACWY-TT, at least 92.3%, had persisting rSBA titers ≥1:8.…”

Meningococcal quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT, Nimenrix™): A review of its immunogenicity, safety, co-administration, and antibody persistence

“…63 No statistically significant differences were seen in terms of vaccine response in either group. However, exploratory analysis showed lower GMTs in the co-administration group as compared to Men-ACWY-TT for serogroups A and C, but higher GMTs to serogroups A, W and Y as compared to Men-PS.…”

“…At the same time, the co-administration group showed antibody responses to the three influenza strains as per the predefined criteria for acceptable immune responses set by the European Medicines Agency Committee for Proprietary Medicinal Products. 63 MenACWY-TT proved to have an acceptable safety profile in adults when co-administered with the influenza vaccine. Pain and headache were the most common solicited local and general AEs respectively in all groups and grade 3 AEs were only rarely reported.…”

“…Otherwise, at the extended 6 month follow up period, there were no reported events. 63 Co-administration with hepatitis A and B vaccine (Twinrix TM , GlaxoSmithKline) Hepatitis A and B cause vaccine preventable liver disease and are a major cause of morbidity and mortality worldwide. 64,65 Their combination in one vaccine was shown to be immunogenic and with a good safety profile in children and adolescents in addition to adults.…”

Meningococcal Vaccines

“…MenACWY-TT aşısının çocuk, adolesan, erişkin ve 55-103 yaş arası popülasyonda da immünojenik ve güvenilir olduğu yapılan çalışmalarda gösterilmiştir (25)(26)(27)(28)(29)(30)(31)(32)(33)(34) . Baxter ve ark.…”