Munoz 2001.
Methods | The study was a prospective, double‐blind, randomized, controlled trial. | |
Participants | Country: United States.
Number: 20 women in the intervention group and 40 women in the control group. Mean age: 30.2 years. Mean gestational age: 33.3 weeks. |
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Interventions | 23‐valent pneumococcal polysaccharide vaccine vs Hemophilus influenzae type b conjugate vaccine. | |
Outcomes | Incidence of neonatal and infant pneumococcal colonization. Neonatal antibody levels (GM). Maternal antibody levels (GM). Incidence of tenderness at the injection site. | |
Notes | ||
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 | 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 | 2/60 were lost to follow‐up. |
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. |