Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds

Tseng, Hung-Fu; Sy, Lina S.; Ackerson, Bradley; Hechter, Rulin C.; Tartof, Sara Y.; Haag, Mendel; Slezak, Jeffrey M.; Luo, Yi; Fischetti, Christine A.; Takhar, Harp S.; Yan, Miao; Cunnington, Marianne; Solano, Zendi; Jacobsen, Steven J.

doi:10.1542/peds.2016-2084

Cited by 26 publications

(25 citation statements)

References 13 publications

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“…Evidence to date does not indicate any major safety signals for the multivalent MenACWY vaccines; however, there was a significant association between Bell's palsy and MenACWY-CRM when administered concomitantly with other vaccines. Further, there was no association when the vaccine was administered alone [132], thus highlighting the need for further investigations. The immunogenicity of co-administration of MenC-CRM and 4CMenB has also been studied with no immediate safety or effectiveness concerns [133].…”

Section: New Approaches For Vaccination Strategiesmentioning

confidence: 92%

The Global Meningococcal Initiative meeting on prevention of meningococcal disease worldwide: Epidemiology, surveillance, hypervirulent strains, antibiotic resistance and high-risk populations

Acevedo

Bai

Borrow

et al. 2018

Expert Review of Vaccines

136

132

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2019) The Global Meningococcal Initiative meeting on prevention of meningococcal disease worldwide: Epidemiology, surveillance, hypervirulent strains, antibiotic resistance and highrisk populations, Expert Review of Vaccines, 18:1, 15-30, ABSTRACT Introduction: The 2018 Global Meningococcal Initiative (GMI) meeting focused on evolving invasive meningococcal disease (IMD) epidemiology, surveillance, and protection strategies worldwide, with emphasis on emerging antibiotic resistance and protection of high-risk populations. The GMI is comprised of a multidisciplinary group of scientists and clinicians representing institutions from several continents. Areas covered: Given that the incidence and prevalence of IMD continually varies both geographically and temporally, and surveillance systems differ worldwide, the true burden of IMD remains unknown. Genomic alterations may increase the epidemic potential of meningococcal strains. Vaccination and (to a lesser extent) antimicrobial prophylaxis are the mainstays of IMD prevention. Experiences from across the globe advocate the use of conjugate vaccines, with promising evidence growing for protein vaccines. Multivalent vaccines can broaden protection against IMD. Application of protection strategies to high-risk groups, including individuals with asplenia, complement deficiencies and human immunodeficiency virus, laboratory workers, persons receiving eculizumab, and men who have sex with men, as well as attendees at mass gatherings, may prevent outbreaks. There was, however, evidence that reduced susceptibility to antibiotics was increasing worldwide. Expert commentary: The current GMI global recommendations were reinforced, with several other global initiatives underway to support IMD protection and prevention. ARTICLE HISTORY

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Section: New Approaches For Vaccination Strategiesmentioning

confidence: 92%

The Global Meningococcal Initiative meeting on prevention of meningococcal disease worldwide: Epidemiology, surveillance, hypervirulent strains, antibiotic resistance and high-risk populations

Acevedo

Bai

Borrow

et al. 2018

Expert Review of Vaccines

136

132

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“…Two GSK-sponsored observational studies using a large US health-care claims database (Kaiser Permanente Southern California) also investigated post-marketing safety of MenACWY-CRM, administered to children and adolescents and young adults in a health-care setting in the US [58,59]. In the first study, the medical records of 387 children 2-10 years of age who received MenACWY-CRM between 30 September 2011 and 30 September 2014 were searched for the occurrence of SAEs or 26 prespecified AEs of interest up to 1 year post vaccination [58].…”

Section: Post-marketing Experience Using Acwy-crmmentioning

confidence: 99%

An update of clinical experience with the quadrivalent meningococcal ACWY-CRM conjugate vaccine

Keshavan¹,

Pellegrini²,

Vadivelu-Pechai

et al. 2018

Expert Review of Vaccines

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Menveo, quadrivalent meningococcal ACWY-CRM conjugate vaccine, was first licensed in 2010 in the United States and has a long track record of immunogenicity and safety in all age groups, including infants from 2 months of age. Areas covered: This review presents clinical and post-marketing experience with MenACWY-CRM from 32 studies conducted in 20 countries that included individuals aged from 2 months to 75 years. Expert commentary: This decade has seen an increased number of countries reporting serogroup W ST-11 clonal complex outbreaks of invasive meningococcal disease. As infant vaccination programs targeting the meningococcus are reevaluated, the role of quadrivalent meningococcal vaccines including MenACWY-CRM will be expanded. MenACWY-CRM was immunogenic in all populations and age groups studied, regardless of country of origin. MenACWY-CRM can be coadministered with many routinely used infant, toddler and adolescent vaccines, and traveler vaccines in adults, allowing for flexible use within national immunization programs and recommendations. Antibody persistence has been demonstrated up to 5 years post vaccination in all age groups. Booster doses induced robust increases in antibody titers for all four serogroups, indicative of effective priming and induction of immunological memory. The acceptable safety profile of MenACWY-CRM has been confirmed in large post-marketing safety studies.

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“…Of the 23 articles collectively evaluated for inclusion, 2 presented results from the same study, with one focusing on immunogenicity and one on safety; 49,50 data from both publications were used as needed. One study was excluded because the concomitant vaccines differed from subject to subject rather than being consistent across all subjects; 51 2 arms of another study were excluded for the same reason. 52 In total, 21 studies were included in this review.…”

Section: Introductionmentioning

confidence: 99%

Concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults: a review of available evidence

Alderfer

Srivastava

Istúriz

et al. 2019

Human Vaccines & Immunotherapeutics

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Invasive meningococcal disease (IMD), a rapidly progressing and potentially fatal illness, disproportionately affects adolescents and young adults. While IMD is best prevented by vaccination, vaccine uptake in these groups is low. An evidence-based understanding of the safety and effectiveness of concomitant vaccination of meningococcal vaccines, including the newer MenB protein vaccines and the more established MenACWY conjugate vaccines, with other vaccines recommended for adolescents and young adults may help maximize vaccination opportunities. We identified 21 studies assessing concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults. Although studies varied in methodology, concomitant administration generally did not affect immunogenicity of the meningococcal or coadministered vaccines. In some cases, reactogenicity increased following concomitant administration, but no definitive safety concerns were raised. In general, data suggest that meningococcal vaccines can be safely and effectively coadministered with other vaccines.

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Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds

Abstract: BACKGROUND: Meningococcal conjugate vaccination is recommended in the United States. This study evaluates the safety of quadrivalent meningococcal conjugate vaccine in a cohort aged 11 to 21 years.

Cited by 26 publications

References 13 publications

The Global Meningococcal Initiative meeting on prevention of meningococcal disease worldwide: Epidemiology, surveillance, hypervirulent strains, antibiotic resistance and high-risk populations

The Global Meningococcal Initiative meeting on prevention of meningococcal disease worldwide: Epidemiology, surveillance, hypervirulent strains, antibiotic resistance and high-risk populations

An update of clinical experience with the quadrivalent meningococcal ACWY-CRM conjugate vaccine

Concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults: a review of available evidence

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