Back to resultsA Systematic Review of Studies of the Effect of Influenza Vaccine Against Mismatched Strains
Primary Purpose
Influenza
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Vaccines
Sponsored by
About this trial
This is an observational trial for Influenza focused on measuring Influenza, Systematic review, Meta-analysis, Mismatched strains, Cross-protection
Eligibility Criteria
Inclusion Criteria:
- Healthy children, adults or the elderly will be included that participated in randomized clinical trials (RCTs) and quasi-RCTs comparing influenza vaccine(s) with placebo.
- Placebo-controlled randomized clinical trials (RCTs) reporting laboratory-confirmed influenza among healthy participants vaccinated with antigens of influenza strains that differed from those circulating.
- All influenza vaccines will be included, and will be categorized as TIV, LAIV, and others (that is, non-TIV or non-LAIV).
- Only RCTs written in English will be included.
Exclusion Criteria:
- RCTs which are not providing any data will be excluded.
- Studies using rapid influenza diagnostic tests will not be included, as their sensitivity is low (especially during flu season) and false positives are common during low activity seasons.
- Laboratory-confirmed influenza through antibody assay as part of the primary outcome will not be included, as this is a less sensitive test than PCR and viral culture.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Arm Label
Cross-Protection Studies
Arm Description
Outcomes
Primary Outcome Measures
Incidence of laboratory-confirmed influenza [Polymerase Chain Reaction (PCR) or viral culture].
Secondary Outcome Measures
Incidence of laboratory-confirmed influenza through antibody assay (a less sensitive test than PCR or viral culture), alone or combined with PCR, and/or viral culture.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01416597
Brief Title
A Systematic Review of Studies of the Effect of Influenza Vaccine Against Mismatched Strains
Official Title
Effect of Influenza Vaccine Against Mismatched Strains: Systematic Review
Study Type
Observational
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to consolidate the cross-protection offered by influenza vaccines against circulating influenza A or B viruses that are not antigenically well-matched to vaccine strains and to determine the degree of cross-protection separately for influenza A and influenza B, through a systematic review of the literature.
Detailed Description
The research question of this project is: "what is the cross-protection afforded by vaccination (using an LAIV, TIV, or other type of vaccine) against influenza A or B and their subtypes and lineages?" The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Statement will be used to guide the reporting of this review. Studies reporting cross-protection data after vaccination with approved formulations of influenza vaccines with influenza A or B will be included. Inclusion will not be limited by publication status, or year of dissemination but will be limited to randomized clinical trials (RCTs) and quasi-RCTs comparing influenza vaccine(s) with placebo. Only RCTs written in English will be included. A meta-analysis will be conducted if there is sufficient data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Systematic review, Meta-analysis, Mismatched strains, Cross-protection
7. Study Design
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cross-Protection Studies
Intervention Type
Biological
Intervention Name(s)
Vaccines
Intervention Description
Unadjuvanted, monovalent, and trivalent vaccines, and vaccines delivered intramuscularly, intradermally, or intranasally, depending on what is found in the included studies.
Primary Outcome Measure Information:
Title
Incidence of laboratory-confirmed influenza [Polymerase Chain Reaction (PCR) or viral culture].
Secondary Outcome Measure Information:
Title
Incidence of laboratory-confirmed influenza through antibody assay (a less sensitive test than PCR or viral culture), alone or combined with PCR, and/or viral culture.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy children, adults or the elderly will be included that participated in randomized clinical trials (RCTs) and quasi-RCTs comparing influenza vaccine(s) with placebo.
Placebo-controlled randomized clinical trials (RCTs) reporting laboratory-confirmed influenza among healthy participants vaccinated with antigens of influenza strains that differed from those circulating.
All influenza vaccines will be included, and will be categorized as TIV, LAIV, and others (that is, non-TIV or non-LAIV).
Only RCTs written in English will be included.
Exclusion Criteria:
RCTs which are not providing any data will be excluded.
Studies using rapid influenza diagnostic tests will not be included, as their sensitivity is low (especially during flu season) and false positives are common during low activity seasons.
Laboratory-confirmed influenza through antibody assay as part of the primary outcome will not be included, as this is a less sensitive test than PCR and viral culture.
Study Population Description
Healthy subjects vaccinated with an influenza vaccine.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Systematic Review of Studies of the Effect of Influenza Vaccine Against Mismatched Strains
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