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Table 2 Quality assessment of vaccine trials for immunization against – Shigella

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

Efficacy against morbidity, Shigella Infection (S.Flexneri): Low-outcome-specific quality

03 [35, 38, 40]

RCT

Random effect model. Insignificant results

Two studies show consistent benefit

Two studies were from developed countries

Two used oral vaccine while one used intramuscular

56

107

0.72 (0.37, 1.39)b

02 [35, 38]

RCT

Random effect model. Insignificant results

One study shows significant benefit

One study from developed country

Oral Vaccines

49

99

0.67 [0.28, 1.59]b

01 [40]

RCT

Only one study

 

Study was conducted in Israel

Parenteral Vaccine

07

08

0.92 [0.33, 2.53]

Efficacy against morbidity, Shigella Infection (S.Sonnei): Low-outcome-specific quality

03 [35, 38, 40]

RCT

Random effect model. Insignificant results

Two studies show consistent benefit

Two studies were from developed countries

Two used oral vaccine while one used intramuscular

39

94

0.47 (0.12, 1.85)b

02 [35, 38]

RCT

Random effect model. Insignificant results

One study shows significant benefit

One study from developed country

Oral Vaccines

10

56

0.39 [0.04, 4.33]b

01 [40]

RCT

Only one study

 

Study was conducted in Israel

Parenteral Vaccines

29

38

0.73 [0.45, 1.17]

One or more Adverse events (S.Flexneri): Low outcome-specific quality

02 [36, 41]

RCT

None

inconsistent results

Both from developing countries

 

45

08

1.58(0.81, 3.07)a

  1. a: Fixed Effect Model
  2. b: Random Effect Model