ab Wright 1976a.
| Methods | 2 studies are reported in the paper:
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| Participants | 33 preschool children aged 3 to 6 were enrolled in Wright 1976 1. 35 children enrolled in the Pediatric Vaccine Clinic at Vanderbilt Hospital (Nashville, Tennessee) aged between 12 and 28 months | |
| Interventions | Children randomly received a single dose of 0.25 mL of monovalent inactivated flu vaccine B/Hong Kong/5/72 (zonally purified, Eli Lilly and Company) containing at least 250 CCA units per dose or saline control at the time of a routine clinic visit. Wright 1976 1 was conducted on preschool children. All children from 1 classroom received 1 dose of vaccine; 8 children from another classroom consisting of 12 children received vaccine, whereas the remaining 4 were given saline solution in double‐blind manner. 3 of these 4 controls received 1 dose of vaccine 6 weeks later. | |
| Outcomes |
Serological
Haemagglutinin inhibition antibody test against 4 units of Flu/B/HK/8/73 antigen Effectiveness N/A Safety Parents of the children completed a questionnaire to record local and systemic reactions such as the temperature at 20:00 on the day of vaccination. Parents were unaware if the children received immunisation. |
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| Funding Source | Industry | |
| Notes | Parents of the children completed a questionnaire to record local and systemic reactions such as the temperature at 20:00 on the day of vaccination. Parents were unaware if the children received immunisation. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | High risk | Not used |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Single |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
| Summary assessments | High risk | Insufficient information to assess study design |