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

Taneja 1965.

Methods Randomized controlled trial
Generation of allocation sequence: not stated
Blinding: double blind
Completeness: not assessable
Surveillance: through participant making a postal, telephone, or clinic notification
Participants Number: 51,135 persons of all ages and both sexes
Previous vaccination status not explicitly given, but it is stated that "previous anti‐cholera vaccination, as usually practiced in an endemic zone" might have influenced the results
Interventions Injected cholera vaccine: Classical bivalent (Ogawa + Inaba)
  • Phenol‐killed whole cell (Vaccine Lab, W Bengal)

  • Phenol‐killed whole cell (India)

  • Formol‐killed freeze‐dried whole cell (Walter Reed)

  • Formol‐killed whole cell (Haffkine Inst, Bombay)


Vaccines made in India contained 8 x 109/dose
Placebo: TAB (CRI)
Route: injected
 Dose: 1 dose; 0.2 mL for ages 2 to 4 years; 0.4 mL for ages 5 to 8 years; 0.6 mL for ages 9 to 12 years; 0.8 mL for ages 13 to 15 years; 1 mL for ages > 15 years
Outcomes
  1. Cholera cases

  2. Adverse effects within 24 hours

Location India: Calcutta
Notes Length of follow up: 6 months after the last vaccination (vaccination occurred during 12 March to 30 June 1964)
WRAIR vaccine (No 3) supply ran short; this group had only 7975 participants compared to 10,784‐10,789 in the other groups
Results from all 4 vaccine groups (all of which are Classical bivalent killed whole cell) have been combined at present
Rates of adverse effects are very different in the 2 publications

Al(OH)3: aluminium hydroxide (alum).

HHS Vulnerability Disclosure