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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

Study Description
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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.

Condition or disease Intervention/treatment
Influenza Biological: Vaccines

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 Design
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Study Type : Observational
Actual Enrollment : 1 participants
Official Title: Effect of Influenza Vaccine Against Mismatched Strains: Systematic Review
Study Start Date : August 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cross-Protection Studies Biological: Vaccines
Unadjuvanted, monovalent, and trivalent vaccines, and vaccines delivered intramuscularly, intradermally, or intranasally, depending on what is found in the included studies.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of laboratory-confirmed influenza [Polymerase Chain Reaction (PCR) or viral culture].

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects vaccinated with an influenza vaccine.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416597


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01416597    
Other Study ID Numbers: 115997
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012
Keywords provided by GlaxoSmithKline:
Influenza
Systematic review
Meta-analysis
Mismatched strains
Cross-protection
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases