Topics

Immunogenicity and safety of high-dose quadrivalent influenza vaccine in Japanese adults ≥65 years of age: a randomized controlled clinical trial.

08:00 EDT 21st October 2019 | BioPortfolio

Summary of "Immunogenicity and safety of high-dose quadrivalent influenza vaccine in Japanese adults ≥65 years of age: a randomized controlled clinical trial."

A trivalent high-dose inactivated influenza vaccine has been licensed in healthy adults ≥65 years of age and provides better protection against influenza infection and related complications than trivalent standard-dose vaccine. This phase I/II clinical trial (NCT03233217), conducted at two sites in Japan, examined the safety and immunogenicity of a quadrivalent formulation of the high-dose inactivated influenza vaccine (IIV4-HD). Healthy adults ≥65 years of age were randomized to receive IIV4-HD by intramuscular injection (n=60), IIV4-HD by subcutaneous injection (n=60), or a quadrivalent standard-dose inactivated influenza vaccine (IIV4-SD) by subcutaneous injection (n=55). Irrespective of administration route, post-vaccination (day 28-35) hemagglutination inhibition geometric mean titers and seroconversion rates were higher for IIV4-HD than for IIV4-SD. Hemagglutination inhibition geometric mean titers and seroconversion rates were also higher for intramuscular than subcutaneous administration of IIV4-HD. Solicited reactions were more common in participants who received IIV4-HD administered subcutaneously than in those who received IIV4-HD administered intramuscularly or IIV4-SD administered subcutaneously. Unsolicited adverse events were similar between the vaccine groups, and no safety signals were detected. This study showed that IIV4-HD administered by either intramuscular or subcutaneous injection was well tolerated and highly immunogenic in healthy Japanese adults ≥65 years of age. Although this study was descriptive, the results add to the evidence that high-dose inactivated influenza vaccines are more immunogenic than standard-dose vaccines in this age group and that intramuscular administration provides greater immunogenicity and lower reactogenicity than subcutaneous administration.

Affiliation

Journal Details

This article was published in the following journal.

Name: Human vaccines & immunotherapeutics
ISSN: 2164-554X
Pages:

Links

DeepDyve research library

PubMed Articles [23309 Associated PubMed Articles listed on BioPortfolio]

Randomized, single-blind, active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose, quadrivalent influenza vaccine) in healthy adults.

Influenza is a major medically attended respiratory illness. The impact of influenza on morbidity and mortality is particularly high in the elderly. Immunosenescence attenuates the immune response of ...

Immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in children and adolescents: A phase III randomized study.

To analyze the immunogenicity and safety of inactivated subunit quadrivalent influenza vaccine (QIV) versus trivalent influenza vaccine (TIV) in children and adolescents 3-17 years of age.

Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial.

Vaccines against human papillomavirus (HPV), tetanus, diphtheria, pertussis (Tdap) and Neisseria meningitidis are widely recommended in adolescents. A phase-4 observer-blind study was performed to inv...

Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain for the 2018/19 Season: Interim Analysis.

Influenza is an important cause of morbidity and mortality in Europe. Prevention by annual vaccination is most effective but with yearly vaccine reformulation to match circulating virus strains, vacci...

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.

Clinical Trials [20182 Associated Clinical Trials listed on BioPortfolio]

A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older

The aim of the study is to assess the safety and immunogenicity of two formulations of the high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent influenza v...

Safety and Immunogenicity of the Butantan Quadrivalent Influenza Vaccine

Studies have showed that a broader spectrum influenza vaccine may help in reducing the influenza burden of disease. Butantan Institute is currently developing a quadrivalent influenza vacc...

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US

This randomized, modified double-blind, active-controlled, multi-center trial will assess the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to...

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

This phase I/II, randomized, modified double-blind, multi-center study will assess the safety and immunogenicity of a high-dose quadrivalent influenza vaccine (QIV-HD) in older adults (≥...

Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.

Medical and Biotech [MESH] Definitions

A vaccine containing L1 capsid proteins from four types of HPV (ALPHAPAPILLOMAVIRUS), types 6, 11, 16 and 18 that is used to prevent infections from HUMAN PAPILLOMAVIRUSES of these subtypes.

The relationship between an elicited ADAPTIVE IMMUNE RESPONSE and the dose of the vaccine administered.

The capacity of VACCINES to stimulate the ADAPTIVE IMMUNE RESPONSE to produce antibodies and antigen-specific T-CELL responses.

A species of FLAVIVIRUS, one of the Japanese encephalitis virus group (ENCEPHALITIS VIRUSES, JAPANESE), found in Australia and New Guinea. It causes a fulminating viremia resembling Japanese encephalitis (ENCEPHALITIS, JAPANESE).

A species of FLAVIVIRUS, one of the Japanese encephalitis virus group (ENCEPHALITIS VIRUSES, JAPANESE), which is the etiological agent of Japanese encephalitis found in Asia, southeast Asia, and the Indian subcontinent.

Quick Search


DeepDyve research library

Relevant Topics

Swine Flu - H1N1 influenza - H7N9
Swine flu is the common name given to a relatively new strain of influenza (flu) that caused a flu pandemic in 2009-2010. It is also referred to as H1N1 influenza (because it is the H1N1 strain of virus). The H1N1 flu virus will be one of the main vi...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Article