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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, 27–30, 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, 28–30]

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