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Meningococcal Quadrivalent Tetanus Toxoid Conjugate Vaccine (MenACWY-TT; Nimenrix): A Review

Sohita Dhillon1 · David Pace2

S. Dhillon
e-mail:
1 Springer, Private Bag 65901, Mairangi Bay 0754, Auckland,
New Zealand
2 Department of Paediatrics, Mater Dei Hospital, Msida, Malta

Table S1. Persistence of immune response 5 years after primary vaccination with MenACWY-TT (Nimenrix) in toddlers, children, adolescents and adults in randomized, open-label, multicentre, phase II [1, 2], IIb[3] and III [4] studies

Study / Capsular / Vaccine / No. of subjects[a] / ≥1:8[b] [% of subjects] / GMT
(age at primary vaccination) / group / rSBA / hSBA / rSBA / hSBA / rSBA / hSBA
Toddlers / A / MenACWY-TT / 49 / 45 / 73.5 / 35.6 / 37.4 / 5.2
(12–23 months)[1, 5] / C / MenACWY-TT / 49 / 48 / 77.6 / 91.7 / 48.9 / 216
MenC-CRM / 11 / 11 / 63.6 / 90.9 / 26.5 / 109
W / MenACWY-TT / 49 / 46 / 34.7 / 82.6 / 18.2 / 59.7
Y / MenACWY-TT / 49 / 45 / 42.9 / 80.0 / 20.6 / 70.6
Children / A / MenACWY-TT / 98 / 90.8[c] / 141.3c
(2–10 years)[1] / MenACWY-PS / 13 / 15.4 / 4.7
C / MenACWY-TT / 98 / 90.8 / 79.7
MenACWY-PS / 13 / 100.0 / 128.0
W / MenACWY-TT / 98 / 78.6c / 208.5c
MenACWY-PS / 13 / 0.0 / 4.0
Y / MenACWY-TT / 98 / 78.6c / 143.3c
MenACWY-PS / 13 / 7.7 / 5.5
Adolescents / A / MenACWY-TT / 236 / 97.5 / 643.8c
(11–17 years)[4] / MenACWY-PS / 86 / 93.0 / 296.0
C / MenACWY-TT / 236 / 88.6 / 248.6
MenACWY-PS / 85 / 87.1 / 366.5
W / MenACWY-TT / 236 / 86.0c / 436.9c
MenACWY-PS / 86 / 34.9 / 19.7
Y / MenACWY-TT / 236 / 96.6c / 1000.2c
MenACWY-PS / 86 / 66.3 / 124.9
Adolescents and adults / A / MenACWY-TT / 141 / 48.9 / 8.9
(11–25 years) [2] / C / MenACWY-TT / 140 / 92.9 / 94.6
W / MenACWY-TT / 138 / 87.0 / 103.5
Y / MenACWY-TT / 142 / 94.4 / 224.6
Adolescents and adults / A / MenACWY-TT / 299 / 90.0c / 303.9c
(11–55 years)[3] / MenACWY-PS / 105 / 74.3 / 103.6
C / MenACWY-TT / 299 / 79.3 / 114.0
MenACWY-PS / 104 / 71.2 / 142.4
W / MenACWY-TT / 299 / 71.6c / 170.2c
MenACWY-PS / 105 / 24.8 / 11.7
Y / MenACWY-TT / 299 / 84.3c / 306.0c
MenACWY-PS / 105 / 44.8 / 29.6

GMT geometric mean antibody titre, hSBA serum bactericidal antibody assay using human complement, MenACWY-PSMencevax, MenC-CRMMeningitec, rSBAserum bactericidal antibody assay using rabbit complement

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Table S2Reactogenicity profile ofMenACWY-TT(Nimenrix)versus other meningococcal vaccines in individuals aged 12 months to >55 years. Data from pooled analyses and individual studies are presented

AE[d] / Age / Comments
Vs. MenC-CRM vaccine Menjugate®[e][6]
Most common local AEs / 2–5 years / Redness (generally similarincidence in both vaccine groups)
6–10 years / Pain (generally similar incidence in both vaccine groups)
Most common general AEs / 2–5years / Irritability (15.4 vs. 11.3%) and drowsiness (14.2 vs.11.3%)
6–10 years / Fatigue (22.3 vs. 22.0%)
Other AEs / 6–10 years / Vaccine-related headache (16.2 vs. 4.0%)
Vs. MenACWY-PS vaccine Mencevax®b[6]
Most common local AE / 2–55 years / Pain (23.3–28.7 vs. 18.5–36.4%)
Local AEs more common with MenACWY-TT / 2–10 years / Grade 3 redness and grade 3 swelling (1.9–3.2 vs. 0%) [both p0.05]
11–17 years / Redness (12.4 vs. 7.0%) and swelling (9.3 vs. 5.6%) [both p0.05]
18–55 years / Pain (24.6 vs. 18.5%) redness (10.5 vs. 5.1%) and swelling (9.0 vs. 2.7%) [all p0.05]
Most common general AEs / 2–5 years / With MenACWY-TT vs. MenACWY-PS: drowsiness (10.1 vs. 8.2%)
With MenACWY-PS vs. MenACWY-TT: irritability (9.6 vs. 7.8%)
6–10 years / With MenACWY-TTvs. MenACWY-PS: headache (12.4 vs. 11%)
With MenACWY-PS vs. MenACWY-TT: fatigue (12.0 vs. 11.8%)
11–17 years / With MenACWY-TTvs. MenACWY-PS: headache (15.8 vs. 12.9%; vaccine-related headache 12.1 vs. 8.5%)
With MenACWY-PS vs. MenACWY-TT: fatigue (14.7 vs. 15.1%)
18–55 years / Headache in both vaccine groups (15.2 vs. 13.4%)
Vs. MenACWY-CRM vaccine Menveo®[7]
Most common local AEs / 12–15 months / Tenderness (26.0 vs. 29.9%)
Most common general AEs / Irritability (39.4 vs. 31.3%), sleepiness (26.5 vs. 24%), change in eating habits (26 vs. 22.9%)

AE adverse event

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References

1. Vesikari T, Forsten A, Bianco V, et al. Antibody persistence up to 5 years after vaccination of toddlers and children between 12 months and 10 years of age with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine. Hum Vaccin Immunother. 2016;12(1):132-9.

2. Baxter R, Baine Y, Kolhe D, et al. Five-year antibody persistence and booster response to a single dose of meningococcal A, C, W and Y tetanus toxoid conjugate vaccine in adolescents and young adults: an open, randomized trial. Pediatr Infect Dis J. 2015;34(11):1236-43.

3. Borja-Tabora CF, Montalban C, Memish ZA, et al. Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. BMC Infect Dis. 2015;15:409.

4. Quiambao BP, Bavdekar A, Dubey AP, et al. Antibody persistence up to five years after vaccination with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in adolescents. Hum Vaccin Immunother. 2017;13(3):636-44.

5. European Medicines Agency. Nimenrix: summary of product characteristics. 2017. Accessed 1 Sep 2016.

6. European Medicines Agency. Nimenrix: assessment report (EMEA/H/C/000113/P46/0017). 2013. Accessed 1 Sep 2017.

7. Bona G, Castiglia P, Zoppi G, et al. Safety and immunogenicity of a CRM or TT conjugated meningococcal vaccine in healthy toddlers. Vaccine. 2016;34(29):3363-70.

[a] According-to-protocol immunogenicity cohort [1, 2, 4] or total cohort [3]

[b] Proportion of subjects with rSBA or hSBA titres of ≥1:8

[c]Statistically significantly higher in the MenACWY-TT group than in the MenACWY-PS group (exploratory analyses)

[d] Solicited local and general any grade or grade 3 AEs occurring within 4 days [6] or 7 days [7] of vaccination

[e] Based on a pooled analysis of data from 7327 individuals, including those who received one dose of MenACWY-TT (2237 aged 12–23 months, 909 aged 2–5 years, 900 aged 6–10 years, 2010 aged 11–17 years and 1271 aged 18–55 years), 103 subjects aged 2–10 years who received one dose of MenC-CRM Menjugate® and 1227 subjects aged 2–55 years who received one dose of MenACWY-PSMencevax®[6]