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A Systematic Review of Studies of the Effect of Influenza Vaccine Against Mismatched Strains

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ClinicalTrials.gov Identifier: NCT01416597
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date August 12, 2011
First Posted Date August 15, 2011
Last Update Posted Date December 17, 2012
Study Start Date August 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2012)
Incidence of laboratory-confirmed influenza [Polymerase Chain Reaction (PCR) or viral culture].
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: December 13, 2012)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy subjects vaccinated with an influenza vaccine.
Condition Influenza
Intervention Biological: Vaccines
Unadjuvanted, monovalent, and trivalent vaccines, and vaccines delivered intramuscularly, intradermally, or intranasally, depending on what is found in the included studies.
Study Groups/Cohorts Cross-Protection Studies
Intervention: Biological: Vaccines
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 12, 2011)
1
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number NCT01416597
Other Study ID Numbers 115997
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date December 2012