Kosuwon 2003.

Methods	Site: Thailand Design: parallel‐group RCT Parents recorded adverse events in diary
Participants	Included: age 4 to 6 years old; healthy, who had received 4 doses of DTwP at 2, 4, 6 and 18 months Excluded: history of diphtheria or tetanus at any time, confirmed pertussis in the previous 5 years, if received vaccines not foreseen in the protocol within 30 days prior to study start or after receiving a study vaccine, history of allergic disease or reactions by any component of the vaccine or previously recorded following previous DTP, history of any serious adverse reactions following previous DTP vaccination, history of administration of immunosuppressive agents, immunoglobulin or blood products within the previous 3 months or during the trial, major congenital defects, neurological including seizure disorders and acute febrile illness
Interventions	Booster (aP versus wP) DTaP: GSK [3] DTwP: GSK [W] Number studied: 165 aP, 165 wP Dose schedule: 1 dose (4 to 6 years) Concurrent vaccine: not stated
Outcomes	Efficacy: not studied Primary series non‐completion (due to adverse events): excluded (booster) Deaths: excluded (booster) Encephalopathy: excluded (booster) Convulsions: no data Hypotonic‐hyporesponsive episodes: no data Minor adverse events: anorexia, drowsiness, fever, irritability, pain/tenderness, redness, swelling/induration
Notes	All symptoms (solicited or unsolicited) were classified by the investigators as not related, unlikely, suspected or probably related. But not a clear temporal definition of this criterion (before or after data collection)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Unclear risk	Details not reported