InfluenzaNCT01416597
A Systematic Review of Studies of the Effect of Influenza Vaccine Against Mismatched Strains
An observational study of Influenza, run by GlaxoSmithKline.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Vaccines
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy subjects vaccinated with an influenza vaccine.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effect of Influenza Vaccine Against Mismatched Strains: Systematic Review
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.
Read the 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.
- Conditions
- Influenza
- Being tested
- Vaccines
- Keywords
- Influenza, Systematic review, Meta-analysis, Mismatched strains, Cross-protection
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccinesBiological
Unadjuvanted, monovalent, and trivalent vaccines, and vaccines delivered intramuscularly, intradermally, or intranasally, depending on what is found in the included studies.
| Study group | Role | What they receive |
|---|---|---|
| Cross-Protection Studies | Not described Receives: Biological: Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of laboratory-confirmed influenza [Polymerase Chain Reaction (PCR) or viral culture].
Secondary outcomes (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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416597
- Sponsor's protocol ID
- 115997
- Status last verified
- Dec 2012
- First submitted
- 12 Aug 2011
- Last updated
- 17 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Influenza Vaccine Against Mismatched Strains: Systematic Review
- ClinicalTrials.gov ID
- NCT01416597
- Acronym / sponsor ID
- 115997
- Conditions
- Influenza
- Keywords
- Influenza, Systematic review, Meta-analysis, Mismatched strains, Cross-protection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-Protection Studies | – | Biological: Vaccines |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy subjects vaccinated with an influenza vaccine.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaccinesUnadjuvanted, monovalent, and trivalent vaccines, and vaccines delivered intramuscularly, intradermally, or intranasally, depending on what is found in the included studies. | Biological | Cross-Protection Studies |
Primary outcome
Incidence of laboratory-confirmed influenza [Polymerase Chain Reaction (PCR) or viral culture].
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of laboratory-confirmed influenza [Polymerase Chain Reaction (PCR) or viral culture].. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.