A Systematic Review of Studies of the Effect of Influenza Vaccine Against Mismatched Strains - Full Text View

Purpose

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	Intervention
Influenza	Biological: Vaccines


Study Type:	Observational
Official Title:	Effect of Influenza Vaccine Against Mismatched Strains: Systematic Review

Resource links provided by NLM:

MedlinePlus related topics: Flu Flu Shot

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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.


Enrollment:	1
Study Start Date:	August 2011
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416597

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01416597 History of Changes
Other Study ID Numbers:	115997
Study First Received:	August 12, 2011
Last Updated:	December 13, 2012

Keywords provided by GlaxoSmithKline:


Influenza Systematic review Meta-analysis Mismatched strains Cross-protection

Additional relevant MeSH terms:


Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections	Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2017