ab Swierkosz 1994.
| Methods | Randomised, double‐blinded, placebo‐controlled trial to assess safety of adding a third dose of a live attenuated, cold‐recombinant, trivalent influenza vaccine | |
| Participants | 22 healthy infants and children aged 2 to 22 months were recruited. 17 were seronegative to all 3 haemagglutinin types, while 2 were seronegative to H3 and B and 2 were seronegative to H1 and B. | |
| Interventions | Children were randomised to receive 3 doses of 0.5 mL vaccine or placebo intranasally in a double‐blinded fashion. 17 children received vaccine and 5 received placebo. Vaccine was administered at day 0, day 60, and day 120. Vaccine contained 3 strains: A/Kawasaki/9/86 (H1N1), A/Los Angeles/2/87 (H3N2), and B/Yamagata/16/88. The vaccine lots contained 108.0, 108.0, and 107.6 TCID50/mL H1N1, H3N2, and B. 106 TCID50 of each strain was present in 0.5 mL of trivalent vaccine. | |
| Outcomes |
Serological
"HAI titres against H1, H3, B and all types (H1, H3 and B) after first dose at day 0, second dose at day 60 and third dose at day 120
ELISA response to H1, H3, B and to all types (H1, H3 and B) after dose first dose at day 0, after second dose at day 60 and third dose at day 120" Effectiveness N/A Safety Adverse reactions were defined as fever (rectal temperature > 38.3 °C, or > 37.2 °C axillary); cough (2 or more episodes during examination on 2 consecutive days); otitis media (red immovable ear drum diagnosed by pneumotoscopy); and lower respiratory tract infection as indicated by wheezing (sustained musical sound during expiration) or pneumonia (a new alveolar consolidation seen radiographically). Clinical observations were recorded daily for 11 days. |
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| Funding Source | Government | |
| Notes | The authors conclude that trivalent, cold‐adapted intranasal influenza vaccine is safe and immunogenic when administered in a 3‐dose regimen. A tiny schedule‐ranging trial. Only 4 children were aged less than 6 months. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not described |
| Summary assessments | Unclear risk | Insufficient information to assess study design |