| Methods |
Randomised controlled trial, double‐blind, conducted in the USA during the 1984 to 1985 influenza season. Follow‐up lasted the whole epidemic period. The influenza period was defined as the interval during which community surveillance recovered influenza viruses from 10% or more of people with febrile respiratory illness per calendar week (from 6 January to 9 March 1985) and lasted 9 weeks. Volunteers were randomly allocated to receive vaccine or placebo using a table of random numbers according to prior vaccination experience. Specimens for culture and acute‐convalescent blood specimens were obtained from ill people. At spring time volunteers were asked to record any illness that occurred during the epidemic period, and blood specimens were collected. |
| Participants |
697 healthy employees working in the Texas Medical Center in Houston, Texas, or in surrounding industrial companies: 456 treated and 241 placebo. Age of participants was 30 to 60. |
| Interventions |
Trivalent, killed, whole, intramuscularly administered vaccine. Schedule and dose were: single dose; 15 µg of haemagglutinin of each influenza strain. Vaccine composition was: A/Philippines/2/82 (H3N2), A/Chile/1/83 (H1N1), and B/USSR/100/83. Placebo was sterile saline for injection. |
| Outcomes |
Outcomes were: ILI, influenza. Illnesses were classified as "any", "flu‐like" (lower respiratory or systemic illness, or both), and "febrile" (oral temperature of 37.8 °C or higher). Laboratory confirmation was based on culture and/or 4‐fold or greater rise in antibody titre occurring between postvaccination (pre‐epidemic), acute, convalescent and/or spring (postepidemic) sera. Surveillance was passive. |
| Notes |
Government funded |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No description |
| Allocation concealment (selection bias) |
Unclear risk |
Unclear |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
No description |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
No description |
| Summary assessment |
Unclear risk |
No description |
