UNITED KINGDOM-NIP SETTING
More than 1 million infants were vaccinated with BEXSERO in a national immunisation programme in the United Kingdom from 2015 to 20174
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Study design: 3-year observational study with impact measured by comparing observed incidence to that expected based on the 4-year prevaccination incidence in equivalent cohorts and using disease trends in vaccine-ineligible cohorts aged <5 years.¹
The same results were first published in the Archive of Diseases in Children, 2020. The graph has been independently created by GSK from the original data.
aNote during the assessment period MenB disease also decreased in the other regions where no vaccination took place; the magnitude of that decrease in younger and older age groups was more than 50%. Taking into account the decrease in MenB incidence at the provincial level, the overall campaign impact in Saguenay—Lac-Saint-Jean, Quebec, Canada was 86% [95% CI: -2%, 98%].2
Study design: Observational study with impact measured by comparing observed incidence before the programme to 4 years post-vaccination in vaccine-eligible cohorts aged 2 months to 20 years.2
In Tuscany, Italy, between 2014 and 2018, children were vaccinated with BEXSERO using a 3+1 dosing schedule starting at 2 months of age. In Veneto, Italy, between 2015 and 2018, children were vaccinated with a 2+1 dosing schedule starting at 7 months of age.3
Study design3: The observational, retrospective study (2014–2018) evaluated vaccine effectiveness and impact in two regions in Italy using two different vaccination protocols (3+1 dosing schedule starting at 2 months of age in Tuscany and 2+1 dosing schedule starting at 7 months of age in Veneto). The data collected referred to the period 2006–2018 for Tuscany and 2007–2018 for Veneto with vaccination beginning in 2014 in Tuscany and 2015 in Veneto. Vaccine impact was calculated by comparing incidence in the pre- and post-vaccination periods. It was evaluated as overall impact (the effect of the BEXSERO vaccination program on the entire population, regardless of vaccination status) and the total impact (the effect of BEXSERO vaccination on the vaccinated population).
*The crude incidence of MenB in Tuscany was 1.96 (95% CI: 1.52; 2.40) per 100,000 children in the pre-vaccine era and it dropped to an ASR of 0.62 (95% CI: 0.60; 0.64; p=0.058) in the post-BEXSERO era.3
**The crude incidence of MenB in Veneto, was 1.94 (95% CI: 1.92; 1.96) in the pre-vaccine era while the ASR in the post-vaccine era was 1.34 (95% CI: 1.31; 1.38, p=ns).3
In an endemic setting in Portugal, the effectiveness of BEXSERO was evaluated in a case-control study from 2014 to 2019 (2 months to 18 years)6
Study design: An observational case-control,* endemicsetting study measured vaccine effectiveness of BEXSERO in children 2 months to 18 years of age in Portugal from 2014 to 2019. (Vaccine uptake: 40% to 60%)6
*A case-control design compares the odds of vaccination in individuals who develop the disease (cases) and those without the disease (controls) who are representative of the population where the cases originate.9
Contraindications10 :
Hypersensitivity to the active substances or to any of the excipients listed as below
Warning and precautions10:
As with other vaccines, administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination
Adverse Events10 :
Very Common : sleepiness, unusual crying, headache Uncommon: seizures (including febrile seizures)
Not known: hypotonic-hyporesponsive episode, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination. diarrhoea, vomiting
References:
For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
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PM-RCH-BEX-WCNT-240001, Date of Preparation July 2024