Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Adolescents and Young Adults 10 to 25 Years of Age

Baxter, Roger; Baine, Yaela; Ensor, Kathleen; Bianco, Véronique; Friedland, Leonard R.; Miller, Jacqueline M.

doi:10.1097/inf.0b013e3182054ab9

Cited by 57 publications

(51 citation statements)

References 18 publications

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“…The safety profile of MenACWY-TT was comparable to that observed in previous studies conducted with adolescents and young adults (42,43). However, a lower incidence of pain at the injection site was observed in two other studies, one conducted with adolescents from India, Taiwan, and the Philippines (26.2%) (44) and the other with adults from Lebanon and the Philippines (19.4%) (36).…”

Section: Discussionsupporting

confidence: 81%

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: 81%

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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“…52 Another phase II randomized controlled study was conducted on 872 subjects aged 10-25 years to assess the immunogenicity of MenACWY-TT using the quadrivalent MenACWY-DT as a comparator. 53 Results confirmed that MenACWY-TT was immunogenic in healthy subjects aged 11 to 25 years. When results in 10 year old children for each serogroup were compared, 83% of the MenACWY-TT group and 70.7% the MenACWY-DT group had hSBA titers 1:4.…”

Section: Immunogenicity Of Menacwy-ttsupporting

confidence: 73%

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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“…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

“…Baxter ve ark. 'nın (29) çalışmasında, 10-25 yaş arası adolesan ve genç erişkinlerde tek doz MenACWY-TT aşısının immünojenik ve güvenilir olduğu saptanmıştır. Benzer şekilde 11-55 yaş arası çocuk ve erişkinlerde de tek doz aşının immünojenik ve güvenilir olduğu bildirilmektedir (22) .…”

Section: Menacwy-tt Ile Ilgili Yürütülen Antikor Sürekliliğiunclassified

Meningococcal Vaccines

Somer¹,

Acar²

2017

Cocuk Dergisi

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Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Adolescents and Young Adults 10 to 25 Years of Age

Abstract: The investigational MenACWY-TT vaccine was immunogenic in adolescents and young adults, with an acceptable safety profile.

Cited by 57 publications

References 18 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 quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT, Nimenrix™): A review of its immunogenicity, safety, co-administration, and antibody persistence

Meningococcal Vaccines

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