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. 2010 Aug 8;2010(8):CD000974. doi: 10.1002/14651858.CD000974.pub2

Benenson 1968a.

Methods Quasi‐randomized controlled trial
Generation of allocation sequence: sequential allocation
Blinding: double blind
Completeness: 100% with adverse effect data
Surveillance: by daily clinical assessments at home
Participants Number: 2801 residents (all ages, both sexes)
87 staff of a military hospital (who had previously been vaccinated many times) and 419 residents of Kadamtali village, Matlab
Interventions Injected cholera vaccines:
  • CRL: Classical bivalent phenol‐killed whole cell

  • 13: Classical bivalent phenol killed whole cell

  • T: lipopolysaccharide (El Tor Ogawa)


Placebos:
  • TAB

  • Tetanus toxoid

  • Saline


Route: injected
 Dose: 1 or 2 doses
Outcomes
  1. Geometric mean agglutinin titre and vibriocidal titre to Ogawa antigen

  2. Adverse effects in 24 hours

Location East Pakistan: Bandar refugee colony, Mudafa (a rural area), and Kaliganj (a semi‐urban area)
Notes Only the military hospital and Kadamtali village have adverse effect data. Data from the military hospital is excluded as it is not possible to match the 164 vaccinations to the 87 subjects (each participant vaccinated twice, often with different vaccines). Data for Kadamtali (for vaccines 1 and 3 combined) have been estimated from a Figure. The placebo was tetanus toxoid
HHS Vulnerability Disclosure