| Methods | Case‐control study to asses correlation between ILIs and influenza immunisation status in schoolchildren aged between 6 and 12 years during an epidemic | |
| Participants | 814 children from 1 of the 9 elementary schools of Kasuga City (Fukoka Prefecture, Japan). Children were aged 6 to 12 years | |
| Interventions | Immunisation with commercial inactivated flu vaccine prepared with the strains A/Yamagata/120/86 (H1N1), A/Fukoka/C29/85 (H3N2), B/Nagasaki/1/87. Each ml of vaccine contained 200 CCA units of each strains. Vaccine was subcutaneously administered in 2 doses of 0.3 ml. Vaccination was carried out after consensus from parents was obtained: the first dose was administered on October 25th while the second on November 16th, 1988. 496 children (60.9%) were not immunised, 187 (23.0%) received 2 doses of vaccine and 131 (16.1%) only 1 dose From data recorded by the Surveillance System for Tuberculosis and Infectious Diseases, an influenza epidemic lasted in Fukoka between October 30th and April 1st (with a sharp peak between December 25th and February 11th), which was caused mainly by the strains A H1N1 (95%), A/H3N2 (3%) and B (2%. Percentages refer to 1575 isolates from all Japan) | |
| Outcomes |
Serological N/A Effectiveness
Cases were defined as:
Controls defined as:
Questionnaires were returned from the parents of 803 children. MILI and SILI groups were composed from 48 and 80 children respectively. Control group NS consisted of 196 children" Safety N/A |
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| Funding Source | Unclear | |
| Notes | "The authors conclude that vaccination was effective against SILI but not MILI‐case definition omits ARI onsets during the first 2 weeks of epidemic peak and those after the period (enhances it for the conservative determination for the risk factor). Immunisation data for MILI were not shown. Criteria for selection of case and controls (i.e. absenteeism and medical consultation) might have introduced selection bias" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| CC‐Case Selection | Unclear risk | Based on self‐report |
| CC‐Control Selection | Unclear risk | Not independent from case selection |
| CC‐Comparability | High risk | No description |
| CC‐Exposure | Low risk | Secure record |
| Summary assessments | High risk | Vaccination was voluntary but its basis was not described |