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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Condition or disease | Intervention/treatment |
---|---|
Influenza | Biological: Vaccines |
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 |

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. |
- Incidence of laboratory-confirmed influenza [Polymerase Chain Reaction (PCR) or viral culture].
- 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.

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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 |
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.

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
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
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 |
Influenza Systematic review Meta-analysis Mismatched strains Cross-protection |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |