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. 2011 Sep 14;4:155–160. doi: 10.2147/IDR.S10339

Table 1.

Description of studies included in review

Clemens et al27 Taylor et al28 Sur et al30 Trach et al29
Used whole cell vaccines and dosage; availability WC-BS (3 doses, 6 weeks apart);* not yet available WC-rBS (2 doses, 2 weeks apart + booster at 10 months); available BivWC (2 doses, 2 weeks apart); available vWC (2 doses, 2 weeks apart); not yet available
Study design Randomized, double blind trial Randomized, double blind trial Randomized, double blind trial Nonrandomized, open label trial
Intervention for control group Heat killed E. coli K12 placebo Heat killed E. coli K12 placebo Heat killed E. coli K12 placebo Heat killed E. coli K12 placebo
Setting, study population Bangladesh, children aged 2–15 years and women over the age of 15 years Peru, residents aged 2 years or more and less than 66 years India, children aged more than 1 year and adults (non-pregnant) Vietnam, residents aged 1 year or more
Population (N) [Children (n)] 62,285 [38,617] 8089 [14,997] 66,900 [19,073] 134,453 [30,414]
Efficacy outcomes
  1. Cases of cholera identified through active surveillance

  2. Cases of diarrhea

  3. Deaths from cholera

  4. All-cause deaths

  1. Cases of cholera identified through active or passive surveillance

  2. Cases of dehydrated participants with cholera

  1. Cases of symptomatic cholera identified through passive surveillance and confirmed microbiologically

  2. All-cause deaths

  1. Cases of cholera requiring inpatient care

  2. Deaths from cholera

  3. Visits to health care centres for treatment of diarrhea

First year: vaccine efficacy (95% CI) Overall 62% (46%–74%) −4% (−88%–43%) 45% (−5%–NA) 66% (46%–79%)
Children ≤ 5 years old 38% (−1%–62%) −291% (−339%–56%) NA 69% (16%–88%)
Children > 5 years old 78% (61%–87%) 16% (−77%–60%) NA 64% (42%–78%)
Second year: vaccine efficacy (95% CI) Overall 58% (40%–71%) 60% (28%–79%) 77% (55%–NA) NA
Children ≤ 5 years old 47% (4%–71%) 52% (−162%–91%) 41% (−13%–69%) NA
Children > 5 years old 63% (41%–77%) 62% (23%–81%) 72% (49%–84%) NA

Notes:

*

The killed whole cell only group was not considered in this review.

Abbreviations: WC-BS, whole cell plus B subunit vaccine; WC-rBS, whole cell plus recombinant B subunit vaccine; BivWC, bivalent whole cell vaccine; vWC, variant whole cell vaccine; NA, data not available; CI, confidence interval; E. coli, Escherichia coli.