ECDC - Technical Document - Protocol for case-control studies to measure influenza vaccine effectiveness in the European Union and European Economic A

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[Table of contents below; full document at link]

Protocol for case-control studies to measure influenza vaccine effectiveness in the European Union and European Economic Area Member States

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Abbreviations ​

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iv​

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1 Background​

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1​

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2 Objectives ​

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3​

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2.1 Primary objectives​

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3​

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2.2 Secondary objectives (for pandemic and seasonal influenza) ​

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3​

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3 Methods​

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4​

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3.1 Study design ​

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4​

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3.2 Study population​

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4​

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3.3 Study period​

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4​

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3.4 Outcome ​

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4​

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3.5 Cases​

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4​

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3.6 Influenza case ​

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4​

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3.7 Laboratory confirmation ​

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4​

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3.8 Case finding ​

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5​

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Case identification ​

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5​

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Case inclusion criteria ​

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5​

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Case exclusion criteria ​

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5​

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3.9 Controls ​

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5​

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3.10 Exposure (vaccination) ​

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6​

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Definition​

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6​

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Ascertainment.​

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6​

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3.11 Risk groups ​

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6​

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Definition and identification ​

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6​

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3.12 Confounding factors and effect modifiers​

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6​

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Chronic diseases ​

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6​

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Severity ​

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7​

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Smoking history ​

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7​

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Previous vaccinations ​

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7​

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Functional status​

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7​

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Number of GP consultations in the previous year​

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7​

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Antivirals administration​

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7​

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Source of information ​

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8​

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3.13 Sample size ​

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3.14 Data​

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10​

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Collected information​

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10​

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Data validation​

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11​

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3.15 Analysis​

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11​

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Individual study analysis ​

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11​

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Pooled analysis ​

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12​

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3.16 Data management ​

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12​

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Individual analysis ​

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12​

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Data cleaning​

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12​

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Pooled analysis ​

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13​

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Missing data​

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13​

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3.17 Potential biases​

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13​

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Negative confounding​

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Positive confounding ​

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13​

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Pooled estimate and its bias​

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13​

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3.18 Consent​

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3.19 Dissemination of results ​

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Publications, scientific communication ​

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3.20 Training​

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4 Logistical aspects​

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4.1 Study leader ​

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4.2 Human resources​

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4.3 Supervision ​

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4.4 Questionnaires ​

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4.5 Computer support​

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4.6 Consent ​

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4.7 Further studies ​

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5 Budget​

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6 References​

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Annexes​

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Annex 1: List of variables, definitions and coding​

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Annex 2: Guidelines for coding (to be developed)​

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Study-specific annexes​

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