Taylor 1999a.

Study characteristics
Methods	Design: Randomized controlled trial (individually randomized) Duration: Enrollment from Jan to Feb 1995; follow‐up for 28 days
Participants	Sample size: 216 enrolled Inclusion criteria: Age 2 to 64 years and residing in the study area, informed consent Exclusion criteria: None stated.
Interventions	Vaccine: Killed whole‐cell vaccine plus recombinant cholera toxin subunit (WC‐rBS; Dukoral®, SBL, Sweden) Placebo: Heat killed E. coli K12 strain All participants were randomized to receive 2 doses, at a minimum interval of 14 days. All doses were administered via pumps designed to deliver the correct dose
Outcomes	Included in review: Adverse events within 3 days of each dose Not included in the review: Immunological outcomes: Geometric mean serum vibriocidal antibody titre, proportion who develop ≥2 or ≥4‐fold rises from baseline after one or two doses
Notes	Location: Flores de Villa, southern Lima Setting: Source of funding: The U.S. Army Medical Material and Development Command.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: 'Vaccination teams were assigned to a section of households using pre‐randomized forms to enter adults and children in the study'.
Allocation concealment (selection bias)	Low risk	Quote: 'Each bottle was identified with a unique number; vaccine and placebo preparations were pre‐coded'.
Blinding (performance bias and detection bias) Efficacy outcomes	Unclear risk	Not applicable as efficacy not reported
Blinding (performance bias and detection bias) Safety outcomes	Low risk	Quote: 'The participants and the persons who assessed side effects were blinded to the vaccine code'. 'The placebo consisted of a suspension of heat‐inactivated E. coli K12 strain (SBL Vaccin AB) in a concentration that matched the turbidity and appearance of the vaccine preparation'.
Incomplete outcome data (attrition bias) Efficacy outcomes	Unclear risk	Not applicable as efficacy not reported
Incomplete outcome data (attrition bias) Safety outcomes	Low risk	Comment: 12 participants were lost to follow‐up between doses. Reasons for drop‐out were not given but follow‐up in the 3 days after each dose was complete.
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting
Other bias	Low risk	No evidence of any other bias