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Is there a Difference in the Immune Response, Efficacy, and Safety of Seasonal Influenza Vaccine in Males and Females? - A Meta-Analysis.
Proposal
6044
Title of Proposed Research
Is there a Difference in the Immune Response, Efficacy, and Safety of Seasonal Influenza Vaccine in Males and Females? - A Meta-Analysis.
Lead Researcher
Caroline Quach
Affiliation
Department of Microbiology, Infectious diseases & Immunology and CHU Sainte-Justine Research Center, Université de Montréal, Montréal, QC, Canada
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
23 August 2021
Lay Summary
Influenza is the leading vaccine-preventable infection that affects Canadians of all ages yearly. Data show that the immune system of males and females do not respond to infections in the same way. Females seem to be able to clear viruses more rapidly. Sex hormones and chromosomes seem to play a role in these differences. When vaccinated with influenza vaccine, females seem to be able to mount a better response against the vaccine, but may also have more adverse events. What we don't know is if this actually translates into better efficacy, i.e., does the vaccine protect females better than males, with the same dose. We therefore aim to review the existing literature in a systematic way and to perform new analyses of data from trials on influenza vaccine, stratified by sex and vaccine type. There is first a need to determine the magnitude of the difference in response to the vaccine between males and females, and then to see how this is translated into public health recommendations.
Study Data Provided
[{ "PostingID": 1795, "Title": "GSK-114269", "Description": "Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults." },{ "PostingID": 1797, "Title": "GSK-112963", "Description": "Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Quadrivalent Influenza Vaccine FLU Q-QIV (GSK2282512A) When Administered Intramuscularly to Adults 18 Years of Age and Older" },{ "PostingID": 2752, "Title": "SANOFI-QID01", "Description": "Immunogenicity and Safety Trial of Quadrivalent Influenza Vaccine Administered by Intradermal Route in Adult Subjects Aged 18 through 64 Years" },{ "PostingID": 4995, "Title": "GSK-ZOS117036", "Description": "Immunogenicity and safety study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with GSK Biologicals’ seasonal influenza vaccine GSK2321138A in adults aged 50 years and older" },{ "PostingID": 5035, "Title": "GSK-117276", "Description": "Immunogenicity and safety study of GSK Biologicals’ Quadrivalent Split Virion Influenza Vaccine 2014/2015 Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) when co-administered with Pneumovax™ 23 in adults 50 years of age and older" },{ "PostingID": 16041, "Title": "GSK-201251", "Description": "Safety and immunogenicity study of GSK Biologicals’ Quadrivalent Influenza Candidate Vaccine (GSK23211381A) manufactured with a new process in adults and children" },{ "PostingID": 19771, "Title": "SANOFI-GQM11", "Description": "Immunogenicity and Lot-to-Lot Consistency Study of a Quadrivalent Influenza Vaccine in Adult and Elderly Subjects" },{ "PostingID": 19774, "Title": "SANOFI-GQM01", "Description": "Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adult and Elderly Subjects" },{ "PostingID": 19775, "Title": "SANOFI-GQM04", "Description": "Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Child/Adolescent and Adult Subjects" },{ "PostingID": 19777, "Title": "SANOFI-GQM07", "Description": "Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 18 to 60 Years in the Republic of Korea" },{ "PostingID": 20283, "Title": "SANOFI-RPV03C", "Description": "Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old" },{ "PostingID": 20284, "Title": "SANOFI-QIV03", "Description": "Study of Quadrivalent Influenza Vaccine Among Adults" },{ "PostingID": 20285, "Title": "SANOFI-QIV06", "Description": "Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India" }]
Statistical Analysis Plan
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