Table 4

Quality assessment of vaccine trials for immunization against – 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

Relative Risk (95% CI)


Effectiveness against very severe rotavirus infection: Moderate/low outcome-specific quality


One

Matched case control

Hospital-based surveillance for cases

NA

Urban and peri-urban hospitals in Nicaragua

Pentavalent vaccine

43

255

74% (35–90%)


Effectiveness against severe rotavirus infection: Moderate/low outcome-specific quality


One

Matched case control

Hospital-based surveillance for cases

NA

Urban and peri-urban hospitals in Nicaragua

Pentavalent vaccine

155

926

61% (38–75%)


Effectiveness against rotavirus hospitalizations: Moderate outcome-specific quality


One

Matched case control

None

NA

Urban and peri-urban hospitals in Nicaragua (-0.5)

Pentavalent vaccine

216

1250

47% (22–64%)

One

Matched case control

None

NA

Rural hospital in the Northern Territory of Australia

Monovalent vaccine

10

58

57% (<0–83%)


Efficacy against severe rotavirus infection: High outcome-specific quality


Eight

RCT

None

Heterogeneity from meta-analysis all studies show benefit

Four studies from developing and four from developed countries

Two used Monovalent Vaccine

237

745

0.17 [0.09, 0.32]b


Efficacy against severe GI infection: Moderate outcome-specific quality


Six

RCT

None

All studies show benefit

Two from developed countries

Two used Monovalent Vaccine

1328

1573

0.68 [0.57, 0.81]b


Efficacy against rotavirus hospitalizations: Moderate outcome-specific quality


Five

RCT

None

All studies show benefit

Four studies from developed countries

Two used Monovalent Vaccine

46

329

0.11 [0.05, 0.27]b


Efficacy against GI hospitalizations: Moderate outcome-specific quality


Two

RCT

None

All studies show benefit

USA, Europe and Latin America

Two of three studies used monovalent vaccine; one used pentavalent.

203

607

0.43 (0.21, 0.9)b


Efficacy against any rotavirus: High outcome-specific quality


Five

RCT

None

All studies show benefit

Four studies from developed countries

One study used monovalent vaccine

586

1348

0.39 [0.25, 0.61]b


a: Fixed Effect Model

b: Random Effect Model

Das et al. BMC Public Health 2013 13(Suppl 3):S11   doi:10.1186/1471-2458-13-S3-S11

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