Lopes 2009.
Methods | Pregnant women were randomly assigned to one of three groups for the study. | |
Participants | Country: Brazil.
Number: 47 women in the control group (no vaccine); 45 women received vaccine at 30‐34 weeks of gestation; and 47 women received vaccine after delivery. Mean age: data not available. Mean gestational age: data not available. |
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Interventions | 23‐valent pneumococcal polysaccharide vaccine. | |
Outcomes | Incidence of neonatal infection. Incidence of infant pneumococcal colonization. Maternal antibody levels (GM). |
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Notes | Data from women received vaccine after delivery were excluded from analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Details were not reported. |
Allocation concealment (selection bias) | Unclear risk | Details were not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Lack of blinding would be unlikely to affect results. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Lack of blinding would be unlikely to affect results. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All infants completed follow‐up at 3 months old. |
Selective reporting (reporting bias) | Low risk | All outcomes were predefined and reported. |
Other bias | Low risk | The trial appears to be free of industry sponsorship. |