Vaccine
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Randomized Controlled Trial
A phase 1, randomized, observer blind, antigen and adjuvant dosage finding clinical trial to evaluate the safety and immunogenicity of an adjuvanted, trivalent subunit influenza vaccine in adults ≥ 65 years of age.
To assess the safety and immunogenicity of the MF59®-adjuvanted trivalent influenza vaccine (aTIV; Fluad®) compared with modified aTIV formulations. ⋯ In this phase I trial of adults ≥ 65 years of age who received increased adjuvant and antigen dosages relative to the licensed aTIV, increased dosage of MF59 resulted in increased immunogenicity against all 3 components of seasonal influenza vaccine. The increase in immunogenicity was accompanied by an increase in the incidence of local reactogenicity.
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Randomized Controlled Trial Multicenter Study Comparative Study
Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adults.
Evaluate whether adjuvanted quadrivalent influenza vaccine (aQIV) elicits a noninferior immune response compared with a licensed adjuvanted trivalent influenza vaccine (aTIV-1; Fluad™) and aTIV-2 containing an alternate B strain, examine whether aQIV had immunological superiority for the B strain absent from aTIV comparators, and evaluate reactogenicity and safety among adults ≥65 years. ⋯ aQIV induces a similar immune response as the licensed aTIV vaccine against homologous influenza strains and has a comparable reactogenicity and safety profile. Superior immunogenicity against the additional B strain was observed, indicating that aQIV could provide a broader protection than aTIV against influenza in older adults (NCT03314662).
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Comparative Study
Comparative effectiveness of high dose versus adjuvanted influenza vaccine: A retrospective cohort study.
Adults 65 years and older (seniors) experience more complications following influenza infection than younger adults. We estimated the relative vaccine effectiveness (rVE) of a trivalent high dose (HD-IIV3) versus an adjuvanted trivalent influenza vaccine (aIIV3) in seniors for respiratory-related hospitalizations. ⋯ Pooled over two predominantly A/H3N2 respiratory seasons, HD-IIV3 was associated with fewer respiratory hospital admissions than aIIV3 in senior members of large national managed health care company in the U.S.
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Comparative Study
Cost-effectiveness of the introduction of two-dose bi-valent (Cervarix) and quadrivalent (Gardasil) HPV vaccination for adolescent girls in Bangladesh.
Cervical cancer is one of the most prevalent cancers in women caused by the human papillomavirus (HPV) that leads to a substantial disease burden for health systems. Prevention through vaccination can significantly reduce the prevalence of cervical cancer. The objective of this study is to evaluate the potential health and economic impacts of introducing two-dose bivalent (Cervarix) and quadrivalent (Gardasil) HPV vaccines in Bangladesh. ⋯ Introducing a two-dose bi-valent HPV vaccination program is cost-effective in Bangladesh at Gavi negotiated prices. Vaccine price is the dominating parameter for the cost-effectiveness of bivalent and quadrivalent vaccines. Both vaccines are not cost-effective at listed prices in Bangladesh. The evaluation highlights that introducing the two-dose bivalent HPV vaccine at Gavi negotiated prices into a national immunization program in Bangladesh is economically viable to reduce the burden of cervical cancer.
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To support vaccine decision-making we estimated from the societal perspective the potential health impact and costs averted through immunization with three vaccines - Haemophilus influenzae type b (Hib), pneumococcal conjugate vaccine (PCV) and rotavirus vaccine (RVV). ⋯ Hib, PCV and RVV vaccine introduction in India can result in immediate benefits to the government and households in terms of savings.