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
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
Tracking Information | ||||
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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 |
Incidence of laboratory-confirmed influenza [Polymerase Chain Reaction (PCR) or viral culture]. | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | ||||
Current 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. | |||
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.
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Study Groups/Cohorts | Cross-Protection Studies
Intervention: Biological: Vaccines
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | GlaxoSmithKline | |||
Verification Date | December 2012 |