Center for Global Research Data

Is there a Difference in the Immune Response, Efficacy, and Safety of Seasonal Influenza Vaccine in Males and Females? – A Meta-Analysis

Lead Investigator: Caroline Quach, CHU Sainte-Justine
Title of Proposal Research: Is there a Difference in the Immune Response, Efficacy, and Safety of Seasonal Influenza Vaccine in Males and Females? – A Meta-Analysis
Vivli Data Request: 7743
Funding Source: This research project is funded by the Canadian Institutes of Health Research (CIHR)
Potential Conflicts of Interest: None

Summary of the Proposed Research:

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.

Requested Studies:

Immunogenicity and Safety Trial of Quadrivalent Influenza Vaccine Administered by Intradermal Route in Adult Subjects Aged 18 Through 64 Years
Data Contributor: Sanofi
Study ID: NCT01712984
Sponsor ID: QID01

Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adult and Elderly Subjects
Data Contributor: Sanofi
Study ID: GQM01

Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Child/Adolescent and Adult Subjects
Data Contributor: Sanofi
Study ID: NCT01481454
Sponsor ID: GQM04

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
Data Contributor: Sanofi
Study ID: NCT02550197
Sponsor ID: GQM07

Immunogenicity and Lot-to-Lot Consistency Study of a Quadrivalent Influenza Vaccine in Adult and Elderly Subjects
Data Contributor: Sanofi
Study ID: GQM11

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
Data Contributor: Sanofi
Study ID: RPV03C

Safety and Immunogenicity Trial Among Adults Administered Quadrivalent Influenza Vaccine
Data Contributor: Sanofi
Study ID: NCT01218646
Sponsor ID: QIV03

Immunogenicity and Safety of a Single Dose or Two Doses Given 28 Days Apart of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 6 Months or Older in India
Data Contributor: Sanofi
Study ID: NCT02451358
Sponsor ID: QIV06