ECDC - Technical Document - Protocol for case-control studies to measure influenza vaccine effectiveness in the European Union and European Economic Area Member States - 17 July 2009

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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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2 Objectives

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2.1 Primary objectives

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2.2 Secondary objectives (for pandemic and seasonal influenza)

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3 Methods

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3.1 Study design

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3.2 Study population

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3.3 Study period

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3.4 Outcome

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3.5 Cases

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3.6 Influenza case

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3.7 Laboratory confirmation

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3.8 Case finding

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Case identification

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Case inclusion criteria

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Case exclusion criteria

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3.9 Controls

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3.10 Exposure (vaccination)

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Definition

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Ascertainment.

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3.11 Risk groups

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Definition and identification

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3.12 Confounding factors and effect modifiers

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Chronic diseases

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Severity

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Smoking history

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Previous vaccinations

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Functional status

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Number of GP consultations in the previous year

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Antivirals administration

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Source of information

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3.13 Sample size

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3.14 Data

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Collected information

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Data validation

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3.15 Analysis

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Individual study analysis

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Pooled analysis

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3.16 Data management

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Individual analysis

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Data cleaning

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Pooled analysis

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Missing data

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3.17 Potential biases

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Negative confounding

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Positive confounding

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Pooled estimate and its bias

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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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