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Table 1 Quality assessment of vaccine trials for immunization against – cholera

From: Vaccines for the prevention of diarrhea due to cholera, shigella, ETEC and rotavirus

  Quality Assessment Summary of Findings
     Directness No of events  
No of Studies Design Limitations Consistency Generalizability to population of interest Generalizability to intervention of interest Intervention Control Risk Ratio
Effectiveness against morbidity, Cholera Infection: Low-outcome-specific quality
02 [6, 32] RCT/Quasi One study was a Quasi Experimental Design All studies show consistent benefit Results can be generalised to population in developing countries Included WC and BS-WC oral vaccines 63 75 0.48 [0.35, 0.64]a
O1 [5] Case Control Random model used   Study was conducted in Mozambique BS-WC vaccine 2 22 0.18 (0.03, 1.08)
Efficacy against morbidity, Cholera Infection: High-outcome-specific quality
02 [29, 33] RCT   All studies show consistent benefit Results can be generalised to population in developing countries Included WC and CVD 103-HgR live oral Vaccines 11 13 0.90 [0.40, 2.03]a
Efficacy/Effectiveness against morbidity- Cholera Infection (Various Types of vaccines)
03 [6, 32, 33] RCT/Quasi One study was a quasi-experimental design Two studies showed significant impact Results can be generalised to population in developing countries WC Vaccines 45 85 0.53 [0.36, 0.76]b
01 [32] RCT Only one study   Study was conducted in Bangladesh BS-WC Vaccines 26 56 0.47 [0.30, 0.74]
01 [29] RCT Only one study   Study was conducted in Indonesia CVD 103-HgR live oral 03 03 1.00 [0.20, 5.00]
Vibriocidal antibody: Low outcome-specific quality
07 [23, 25, 2730, 65] RCT None Results from analysis significant. Five studies show benefit All from Developing Countries All Oral Vaccines 503 234 2.24 (1.32, 3.80)b
03 [23, 27, 31] RCT   Two studies show benefit All from Developing Countries Oral Killed Vaccines 202 205 0.97 [0.75, 1.25]b
04 [25, 2830] RCT   Three studies show significant benefit All from Developing Countries Oral Live Vaccines 301 29 10.73 [1.94, 59.37]b
One or more Adverse effect: Low outcome-specific quality
06 [24, 25, 27, 28, 30, 32, 33] RCT None significant results All from developing countries All Oral Vaccines 132 91 1.42 (1.06, 1.89)a
  1. a: Fixed Effect Model
  2. b: Random Effect Model