Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: Results of an open-label, randomized, phase 3b controlled study in healthy infants

Abdelnour, Arturo; Silas, Peter; Lamas, Marta Raquel Valdés; Aragón, Carlos Fernándo Grazioso; Chiu, Nan-Chang; Chiu, Cheng-Hsun; Acuña, Teobaldo Herrera; Castrejón, Tirza De León; Izu, Allen; Odrljin, Tatjana; Smolenov, Igor; Hohenboken, Matthew; Dull, Peter

doi:10.1016/j.vaccine.2013.12.034

Cited by 19 publications

(19 citation statements)

References 13 publications

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“…22 As already shown in other clinical trials in which MenACWY-CRM was administered alone or with routine pediatric vaccines, injection site tenderness and irritability were the most frequently reported solicited local and systemic AEs for young chil-dren<2 years of age. 12,13,[23][24][25] Overall, in pre-licensure trials, solicited AEs were observed in ≥50% of children receiving vaccination until 23 months of age, in line with observations made in our study. Unsolicited AEs occurred with similar or lower frequency to that reported in a large phase 3 multicountry pivotal safety study in 5772 infants, who received MenACWY-CRM co-administered with routine vaccines, with overall incidences of AEs observed up to 84%.…”

Section: Discussionsupporting

confidence: 91%

“…The meningococcal ACWY quadrivalent CRM 197 -conjugate vaccine (MenACWY-CRM; Menveo, GSK) is approved for use in different age groups in many countries. 11 The vaccine has been shown to be immunogenic, able to prime immunological memory, and well tolerated in infants, 12,13 children, 14 adolescents and adults. [15][16][17] MenACWY-CRM was initially licensed in the Republic of Korea for use in individuals aged 11-55 years in 2012, and subsequently in children aged 2-11 years and infants ≥2 months of age in 2013 and 2014, respectively.…”

Section: Introductionmentioning

confidence: 99%

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Results from a large post-marketing safety surveillance study in the Republic of Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 2 months–55 years

Yoo

Jung

Byeon³

et al. 2019

Human Vaccines & Immunotherapeutics

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The quadrivalent meningococcal conjugate vaccine MenACWY-CRM is approved in the Republic of Korea for use in individuals from 2 months of age. This single-arm, open-label, observational, multicenter, post-marketing study (NCT01766206) assessed the safety of MenACWY-CRM vaccine administered according to local clinical practice. A total of 3939 individuals aged 2 months-55 years provided safety data post-vaccination; the analysis was conducted on the per-protocol set (3920 participants). Solicited and unsolicited adverse events (AEs) were collected over 7 days post-vaccination and medically-attended AEs (MAAEs) and serious AEs (SAEs) over 29 days post-vaccination. Among recorded solicited AEs, injection site AEs were reported by 21.38% of participants, with tenderness/pain being most frequent across age groups; systemic AEs were reported in 13.95% of participants, with irritability (in ˂6-year-olds), headache and myalgia (in ≥6 year-olds) being the most frequently reported. Most solicited AEs were mild or moderate in nature. The percentage of participants reporting unsolicited AEs varied in the study population, i.e. 12.56% in participants aged 2-23 months and 3.18% in those ≥2 years of age. Overall, less than 22% of unsolicited AEs were considered as related to vaccination. MAAEs (10.89% of participants) were mostly mild; 2.82% were considered as related to vaccination. Three (0.46%) and 5 (0.15%) SAEs (none vaccination-related) occurred in participants aged 2-23 months and 2-55 years, respectively. No deaths were reported. The safety profile for MenACWY-CRM in this postmarketing surveillance was consistent with observations from studies conducted during the vaccine's clinical development, with no new safety concerns. ARTICLE HISTORY

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Results from a large post-marketing safety surveillance study in the Republic of Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 2 months–55 years

Yoo

Jung

Byeon³

et al. 2019

Human Vaccines & Immunotherapeutics

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“…The incidence of meningococcal infections in patients with congenital complete deficiency in terminal complement factors is 0.5 % per year, a relative risk of 5,000 compared to the normal population [102]. Prevention of meningococcal infection is therefore crucial in eculizumab-treated patients, relying on vaccination and antibiotic prophylaxis (Box 2) [103][104][105][106]. The tetravalent conjugated vaccines protect against serogroups A, C, W135 and Y, but not against serogroup B which predominates in European countries, North America, Australia and New Zealand.…”

Section: The Risk Of Meningococcal Infection Under Eculizumabmentioning

confidence: 99%

An international consensus approach to the management of atypical hemolytic uremic syndrome in children

et al. 2015

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Atypical hemolytic uremic syndrome (aHUS) emerged during the last decade as a disease largely of complement dysregulation. This advance facilitated the development of novel, rational treatment options targeting terminal complement activation, e.g., using an anti-C5 antibody (eculizumab). We review treatment and patient management issues related to this therapeutic approach. We present consensus clinical practice recommendations generated by HUS International, an international expert group of clinicians and basic scientists with a focused interest in HUS. We aim to address the following questions of high relevance to daily clinical practice: Which complement investigations should be done and when? What is the importance of anti-factor H antibody detection? Who should be treated with eculizumab? Is plasma exchange therapy still needed? When should eculizumab therapy be initiated? How and when should complement blockade be monitored? Can the approved treatment schedule be modified? What approach should be taken to kidney and/or combined liver-kidney transplantation? How should we limit the risk of meningococcal infection under complement blockade therapy? A pressing question today regards the treatment duration. We discuss the need for prospective studies to establish evidence-based criteria for the continuation or cessation of anticomplement therapy in patients with and without identified complement mutations.

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“…In all cases, the vaccines induced high-affinity antibodies in infants, and they eliminated both the disease and the carriage of bacteria from the immunized population. During the past decade, the same technology has been used to develop vaccines against meningococcus serogroups A, C, Y and W 36,37 and against six additional pneumococcus serotypes, making possible a 13-valent pneumococcal conjugate vaccine 38 . Clinica l studies have recently been carried out with conjugate vaccines against group B streptococcu s 39 and typhoid fever 40,41 .…”

Section: Glycoconjugate Vaccinesmentioning

confidence: 99%

From empiricism to rational design: a personal perspective of the evolution of vaccine development

2014

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Vaccination, which is the most effective medical intervention that has ever been introduced, originated from the observation that individuals who survived a plague or smallpox would not get the disease twice. To mimic the protective effects of natural infection, Jenner - and later Pasteur - inoculated individuals with attenuated or killed disease-causing agents. This empirical approach inspired a century of vaccine development and the effective prophylaxis of many infectious diseases. From the 1980s, several waves of new technologies have enabled the development of novel vaccines that would not have been possible using the empirical approach. The technological revolution in the field of vaccination is now continuing, and it is delivering novel and safer vaccines. In this Timeline article, we provide our views on the transition from empiricism to rational vaccine design.

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Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: Results of an open-label, randomized, phase 3b controlled study in healthy infants

Cited by 19 publications

References 13 publications

Results from a large post-marketing safety surveillance study in the Republic of Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 2 months–55 years

Results from a large post-marketing safety surveillance study in the Republic of Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 2 months–55 years

An international consensus approach to the management of atypical hemolytic uremic syndrome in children

From empiricism to rational design: a personal perspective of the evolution of vaccine development

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