Obaro 2004.
Methods | The study was a randomized, double‐blind, controlled trial. | |
Participants | Country: The Gambia.
Number: 56 women in the intervention group and 57 women in the control group. Mean age: data not available. Mean gestational age: data not available. |
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Interventions | 23‐valent pneumococcal polysaccharide vaccine vs meningococcal vaccine. | |
Outcomes | Pneumococcal polysaccharide‐specific s‐IgA antibody concentrations in breast milk. | |
Notes | Did not contribute data to analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were vaccinated with 1 dose of either a pneumococcal vaccine or control by computer‐generated random assignment. |
Allocation concealment (selection bias) | Unclear risk | Details were not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: “double blind”. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “double blind”. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two mothers withdrew their consent before the completion of the study, and 6 mothers traveled out of the study area and did not return before the completion of the study. |
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. |