Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlers

Tregnaghi, Miguel; López, Pío; Stamboulián, Daniel; Graña, Gabriela; Odrljin, Tatjana; Bedell, Lisa; Dull, Peter

doi:10.1016/j.ijid.2014.03.1390

Cited by 24 publications

(35 citation statements)

References 10 publications

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“…Geometric mean titers were also modest across serogroups. Similarly, by 6 months after a 3-dose series of MenACWY-CRM given at 2, 4 and 6 months of age in infants, 9,10 antibody titers declined to different degrees across serogroups, with more than half of the infants retaining antibody titers 8 against serogroups C, W and Y at 6 months after vaccination (Fig. 3).…”

Section: Persistence After Multi-dose Vaccination Series In Infants Amentioning

confidence: 85%

“…[7][8][9][10] This review appraises data from 7 phase 3 and phase 4 studies, with the objective of providing an overview of antibody persistence following primary vaccination with MenACWY-CRM vaccine, and responses to booster doses of the vaccine. 9,10,[11][12][13][14][15][16][17][18][19] Only data pertaining to the recommended dose schedules of MenACWY-CRM in each age group is assessed here : a single dose in children 2-10 y of age, adolescents and adults; 4 doses at 2, 4, 6 and 12 months of age in infants; and 2 doses given to unvaccinated children between 7-23 months of age. All the studies included in this review were conducted in accordance with good clinical practice and International Conference on Harmonisation of Techniques for Requirements for Registration of Pharmaceuticals for Human Use guidelines, and were approved by Institutional Review Boards (IRBs) or Ethics Committees (ECs) in each country, as appropriate, prior to start of the study.…”

Section: Introductionmentioning

confidence: 99%

“…Long-term safety assessments did not indicate any specific safety concern, across studies and age groups. 9,10,[13][14][15][16]18 MenACWY-CRM was also well-tolerated as a booster, with no difference in local or systemic reactogenicity compared to single-or multiple-dose primary vaccinations. 14,16,18 In the studies involving a booster vaccination (studies 3, 4 and 7), the most commonly reported local reaction after booster was pain at the injection site (or tenderness in infants), while the most commonly reported systemic reaction was irritability in infants, toddlers and young children, and headache in older children and adolescents.…”

mentioning

confidence: 95%

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Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants

Baxter

Keshavan

Welsch

et al. 2016

Human Vaccines & Immunotherapeutics

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Persistence of bactericidal antibodies following vaccination is extremely important for protection against invasive meningococcal disease, given the epidemiology and rapid progression of meningococcal infection. We present an analysis of antibody persistence and booster response to MenACWY-CRM, in adolescents, children and infants, from 7 clinical studies. Immunogenicity was assessed using the serum bactericidal assay with both human and rabbit complement. Post-vaccination hSBA titers were high, with an age-and serogroup-specific decline in titers up to 1 y and stable levels up to 5 y The waning of hSBA titers over time was more pronounced among infants and toddlers and the greatest for serogroup A. However, rSBA titers against serogroup A were consistently higher and showed little decline over time, suggesting that protection against this serogroup may be sustained. A single booster dose of MenACWY-CRM administered at 3 to 5 y induced a robust immune response in all age groups.

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Section: Persistence After Multi-dose Vaccination Series In Infants Amentioning

confidence: 85%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 95%

See 1 more Smart Citation

Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants

Baxter

Keshavan

Welsch

et al. 2016

Human Vaccines & Immunotherapeutics

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“…The remaining four abstracts were considered not relevant with respect to objectives or did not report data on co-administration of RV and meningococcal vaccines. Eleven studies provided information on the safety profile of co-administration of RV vaccines and meningococcal vaccines [20][21][22][23][24][25][26][27][28][29][30] and five studies reported data on immunogenicity. 21,22,24,29,31 No studies presented data on vaccine efficacy.…”

Section: Resultsmentioning

confidence: 99%

Systematic literature review on the safety and immunogenicity of rotavirus vaccines when co-administered with meningococcal vaccines

Pereira

Benninghoff

Moerman

2020

Human Vaccines & Immunotherapeutics

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This study is aimed to review the published evidence on safety, immunogenicity, and efficacy of rotavirus vaccines when co-administered with meningococcal vaccines in infants. A systematic literature search was performed in four databases containing peer-reviewed articles and conference abstracts. In total, twelve articles were included in the review; 11 provided information on safety and five on the immunogenicity of rotavirus vaccines following co-administration. No paper was found on efficacy. Additional routine vaccines were administered in all studies. The safety analysis was mainly focused on fever, vomiting, diarrhea, intussusception, and changes in eating habits. Overall, safety profiles and immune responses associated with rotavirus vaccination were comparable between infants co-administered with rotavirus and meningococcal vaccines and infants receiving rotavirus vaccines without meningococcal vaccines. Although data are limited, co-administration of rotavirus and meningococcal vaccines does not appear to interfere with the safety or immunogenicity of rotavirus vaccines.

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“…It is well known that conjugate vaccines in children less than 2 years of age are highly immunogenic and induce substantial Bcell memory in young infants, which make them more efficacious than polysaccharide vaccines [16]. Studies have shown that a quadrivalent meningococcal conjugate vaccine Men ACWY-CRM used in infants and toddlers was immunogenic and well tolerated [17,18]. The UK experience with the conjugate meningococcal serogroup C vaccine resulted in decreased hospital admissions with meningococcal diseases in children from 34.5/100,000 in 1999 to 12.4/100,000 in 2011 [19].…”

Section: Discussionmentioning

confidence: 99%

Trends and variations in the epidemiology of meningococcal disease in Kuwait 1987–2013

Husain¹,

Barakat²,

Al-Saleh³

2015

Journal of Infection and Public Health

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The introduction of Haemophilus influenzae type b (Hib) conjugate vaccine and conjugate pneumococcal vaccine into routine childhood vaccination in Kuwait has resulted in the emergence of Neisseria meningitidis as the leading cause of invasive bacterial infection in children. Currently, a quadrivalent ACYW-135 meningococcal polysaccharide vaccine is administered as part of routine childhood vaccination in Kuwait at the age of 2 years. Conjugate meningococcal vaccines have been shown to be more effective in preventing meningococcal infection in young children. The objective of this study was to describe the epidemiology of meningococcal disease (MD) in Kuwait and evaluate the need for conjugate vaccine in routine childhood immunization. We have reviewed the MD surveillance data from the communicable disease unit, Ministry of Health, Kuwait during the period from 1987 to 2013. The analysis included microbiologically confirmed cases of N. meningitidis in the blood and cerebrospinal fluid. There were 293 cases of confirmed MD during the study period. Two hundred and four cases (70%) were in children ≤ 14 years of age. The mean incidence rate was 0.5/100,000 persons. The dominant serogroups were W-135 and B, accounting for 80 cases (32%) each. Serogroup B accounted for 69/204 (34%) of all cases in children ≤ 14 years and serogroup A accounted for 36/89 40% of all adult cases. There were three outbreaks: 1987 (caused by serogroup A), 1989 (caused by serogroup W-135) and 2002 (caused by serogroup B). The mean case fatality rate was 13.5%. In conclusion, despite childhood routine vaccination with ACYW-135 polysaccharide vaccine, infants and young children remain at high risk for MD, which supports the introduction of conjugate meningococcal vaccine to the routine childhood vaccination schedule.

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Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlers

Abstract: MenACWY-CRM vaccination regimens in infants and toddlers were immunogenic and well tolerated. No clinically meaningful effects of concomitant administration with routine infant and toddler vaccines were observed.

Cited by 24 publications

References 10 publications

Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants

Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants

Systematic literature review on the safety and immunogenicity of rotavirus vaccines when co-administered with meningococcal vaccines

Trends and variations in the epidemiology of meningococcal disease in Kuwait 1987–2013

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