Last updated: 11/07/2018 10:03:12
A Systematic Review of Studies of the effect of influenza vaccine against mismatched strains
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Effect of influenza vaccine against mismatched strains: Systematic Review
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Incidence of laboratory-confirmed influenza [Polymerase Chain Reaction (PCR) or viral culture].
Timeframe: Not Applicable.
Secondary outcomes:
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.
Timeframe: Not Applicable.
Interventions:
Biological/vaccine: Vaccines
Enrollment:
1
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Other
Clinical publications:
Tricco AC et al. (2012) Effect of influenza vaccines against mismatched strains: A systematic review protocol. Syst Rev. 1:35.
Tricco AC et al. (2013) Comparing influenza vaccine efficacy against mismatched and matched strains: a systematic review and meta-analysis. BMC Med. 11:153.
Medical condition
Influenza
Product
GSK1536489A, GSK1562902A, GSK2340274A, SB218352
Collaborators
Not applicable
Study date(s)
August 2011 to December 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.
Exclusion criteria:
- 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.
RCTs which are not providing any data will be excluded.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2011-12-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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