A dose-range study assessing immunogenicity and safety of one dose of a new candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered in the second year of life and in young children

Knuf, Markus; Kieninger‐Baum, Dorothee; Habermehl, P.; Muttonen, P.; Maurer, Helen S.; Vink, Peter; Poolman, Jan; Boutriau, Dominique

doi:10.1016/j.vaccine.2009.10.064

Cited by 74 publications

(69 citation statements)

References 27 publications

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“…Pain at the injection site tended to be reported more frequently for participants who received the MenACWY-TT vaccine than the Men-PS vaccine. This observation is consistent with previous studies showing that injection site reactions are more frequent in individuals vaccinated with MenACWY-TT versus Men-PS (35,36,45,46) and those vaccinated with other quadrivalent meningococcal conjugate vaccines versus plain PS vaccines (47,48). It is likely that the increased reactogenicity following vaccination with the MenACWY-TT vaccine is due to the TT component (49).…”

Section: Discussionsupporting

confidence: 92%

Meningococcal Polysaccharide A O -Acetylation Levels Do Not Impact the Immunogenicity of the Quadrivalent Meningococcal Tetanus Toxoid Conjugate Vaccine: Results from a Randomized, Controlled Phase III Study of Healthy Adults Aged 18 to 25 Years

Lupisan

Limkittikul

Sosa³

et al. 2013

Clin Vaccine Immunol

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(ACWY-B) (92% O-acetylation), or Men-PS (82% O-acetylation).Immunogenicity was evaluated in terms of serum bactericidal activity using rabbit complement (i.e., rabbit serum bactericidal activity [rSBA]). Solicited symptoms, unsolicited adverse events (AEs), and serious AEs (SAEs) were recorded. The immunogenicities, in terms of rSBA geometric mean titers, were comparable for both lots of MenACWY-TT. The vaccine response rates across the serogroups were 79.1 to 97.0% in the two ACWY groups and 73.7 to 94.1% in the Men-PS group. All subjects achieved rSBA titers of >1:8 for all serogroups. All subjects in the two ACWY groups and 99.5 to 100% in the Men-PS group achieved rSBA titers of >1:128. Pain was the most common solicited local symptom and was reported more frequently in the ACWY group (53.9 to 54.7%) than in the Men-PS group (36.8%). The most common solicited general symptoms were fatigue and headache, which were reported by 28.6 to 30.3% and 26.9 to 31.0% of subjects, respectively. Two subjects reported SAEs; one SAE was considered to be related to vaccination (blighted ovum; ACWY-B group). The level of serogroup A PS O-acetylation did not affect vaccine immunogenicity. Men-ACWY-TT (lot A) was not inferior to Men-PS in terms of vaccine response and was well tolerated.

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Section: Discussionsupporting

confidence: 92%

Meningococcal Polysaccharide A O -Acetylation Levels Do Not Impact the Immunogenicity of the Quadrivalent Meningococcal Tetanus Toxoid Conjugate Vaccine: Results from a Randomized, Controlled Phase III Study of Healthy Adults Aged 18 to 25 Years

Lupisan

Limkittikul

Sosa³

et al. 2013

Clin Vaccine Immunol

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“…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.…”

Section: Menacwy-tt Ile Ilgili Yürütülen Antikor Sürekliliğiunclassified

“…Knuf ve ark. 'nın (28) çalışmalarında MenACWY-TT ile MenC-CRM197 (Meningitec TM , Wyeth) ve PS aşıları (Mencevax TM ) karşılaştırılmış ve aşıların genel olarak iyi tolere edildiği, özellikle 12-14 ay ve 3-5 yaş arası grupta 3. derece olarak belirtilen yan etki insidansının her grup için düşük olduğu ve bu yaş grubunda en sık saptanan lokal yan etkinin aşı yerinde kızarıklık gelişimi olduğu ifade edilmiştir. Dokuzuncu ayda aşılanan çocukların incelendiği diğer bir çalışmada, %3.3 oranında ateş göz-lenmiş olup, hiçbir vakada >40°C'nin üzerine çıkma-dığı raporlanmıştır (24) .…”

Section: Menacwy-tt Ile Ilgili Yürütülen Antikor Sürekliliğiunclassified

Meningococcal Vaccines

Somer¹,

Acar²

2017

Cocuk Dergisi

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“…MenACWY-TT was initially assessed using four formulations of the experimental vaccine in 240 healthy 12 to 14 months toddlers from multiple clinics in Germany and Austria. 42 Subjects received either monovalent meningococcal C conjugate vaccine (MenC-CRM197, Meningitec TM ) or one of the four MenACWY-TT formulations. All formulations were found to be immunogenic with a vaccine response against the four serogroups in 91.1% of subjects.…”

Section: Immunogenicity Of Menacwy-ttmentioning

confidence: 99%

“…At least 97.7% achieved a post vaccination rSBA titers 1:8 against all serogroups after a single dose of MenACWY-TT. 42 Following this study, the formulation containing 5 mg of each of the four meningococcal PS antigens with spacer technology for PS A and C, which had the best immune response, was selected for further development. 42 In another study, Vesikari et al demonstrated in 304 healthy toddlers aged 12 to 23 months that MenACWY-TT was non-inferior to MenC-CRM197 in terms of immunogenicity to serogroup C and the prespecified immunogenicity criteria for the other serogroups were met.…”

Section: Immunogenicity Of Menacwy-ttmentioning

confidence: 99%

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

Assaf-Casals

Dbaibo

2016

Human Vaccines & Immunotherapeutics

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Introduction: Meningococcal disease is a major cause of morbidity and mortality worldwide with reported epidemics and outbreaks in different parts of the world. Despite the availability of antimicrobial therapy, challenges remain in early recognition and prevention of disease. Several vaccines have been developed to date aiming at preventing disease spread. Discussion: MenACWY-TT (Nimenrix TM ) has been extensively studied for use in different age groups. Phase II and III randomized trials have demonstrated its immunogenicity when administered in children aged 1 year and older, adolescents and adults. It has an acceptable safety profile with minor adverse events comparable to other vaccines. Follow up studies have shown persistence of protective antibodies up to three years. MenACWY-TT was safely and effectively coadministered with different recommended vaccines. Conclusion: MenACWY-TT is a safe and immunogenic vaccine that can be used to protect against these four serogroups in individuals older than 1 year of age.

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A dose-range study assessing immunogenicity and safety of one dose of a new candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered in the second year of life and in young children

Cited by 74 publications

References 27 publications

Meningococcal Polysaccharide A O -Acetylation Levels Do Not Impact the Immunogenicity of the Quadrivalent Meningococcal Tetanus Toxoid Conjugate Vaccine: Results from a Randomized, Controlled Phase III Study of Healthy Adults Aged 18 to 25 Years

Meningococcal Polysaccharide A O -Acetylation Levels Do Not Impact the Immunogenicity of the Quadrivalent Meningococcal Tetanus Toxoid Conjugate Vaccine: Results from a Randomized, Controlled Phase III Study of Healthy Adults Aged 18 to 25 Years

Meningococcal Vaccines

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

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